Portable bladder ultrasound · Portable bladder ultrasound products are portable ultrasound devices that use automated technology to digitally register bladder volume, including post-void

Portable bladder ultrasound Health Technology Policy Assessment Pre-edit Proof Completed April 2006

Portable bladder ultrasound

Disclaimer

This health technology scientific literature and policy review was prepared by the Medical Advisory Secretariat Ontario Ministry of Health and Long-Term Care for the Ontario Health Technology Advisory Committee and developed from analysis interpretation and comparison of scientific research andor technology assessments conducted by other organizations It also incorporates when available Ontario data and information provided by experts and applicants to the Medical Advisory Secretariat to inform the analysis While every effort has been made to do so this document may not fully reflect all scientific research available Additionally other relevant scientific findings may have been reported since completion of the review Please contact MASInfomohgovonca if you are aware of scientific research findings that should inform the report or would like further information

The Medical Advisory Secretariat Ministry of Health and Long-Term Care 56 Wellesley Street West 8th floor Toronto ON CANADA M5S 2S3 Email MASinfomohgovonca ISBN

Table of Contents Portable bladder ultrasound 1

Executive Summary 5

Abbreviations 7

Issue 8

Background 8

Clinical Need Target Population and Condition 8

Existing Treatments Other Than Technology Being Reviewed 12

New Technology Being Reviewed 14

History 14

Literature Review on Effectiveness 17

Results of Literature Review 19

Summary of Findings of Literature Review 20

Summary of Existing Health Technology Assessments 20

Summary of Controlled Diagnostic Experiments Prospective Clinical Series 20

Summary of Observational Studies 27

Medical Advisory Secretariat Review 28

Economic Analysis 32

Results of Literature Review on Economics 32

Ontario-Based Economic Analysis 33

Diffusion 33

Demographics 34

Economic Model 35

Costs 36

Existing Guidelines for Use of Technology 37

AppraisalPolicy Development 38

Policy Options 41

Appendices 42

Appendix 1 42

Appendix 2 44

Appendix 3 46

References 47

Executive Summary

Purpose In May 2005 the Continence Care Panel was formed to identify ways of integrating the continence care technologies reviewed by MAS (sacral nerve stimulation (SNS) and tension-free vaginal tape (TVT)) into the management pathways for continence in Ontario At the first meeting of the Panel in June 2005 it became clear that prior to incorporating SNS and TVT into the management of incontinence better consistency in the diagnosis prevention and the initial management of incontinence was required The Guidelines Advisory Committee (GAC) has prioritized continence care on its agenda and will work on the guidelines with members of the Continence Care Panel During the Continence Care Panel discussions it became apparent that there were other technologies used in the management of urinary conditions that were recommended for review by OHTAC These technologies include hydrophilic catheters bladder ultrasound and pessaries This health technology and policy assessment (HTPA) will focus specifically on portable bladder ultrasound The Technology Portable bladder ultrasound products are portable ultrasound devices that use automated technology to digitally register bladder volume including post-void residual (PVR) and provide 3-D images of the bladder The predominant clinical use of portable bladder ultrasound is diagnostic where health professionals (predominantly nurses) administer the device to measure PVR in order to prevent unnecessary catheterization Adjunctive functions of the bladder ultrasound device can be utilized in order to visualize the placement and removal of catheters Portable bladder ultrasound products may also be used in the diagnosis and differentiation of urological problems management and treatment including the establishment of voiding schedules bladder biofeedback reduction of urinary tract infections (UTI) and in post-operative and trauma monitoring of potential urinary incontinence (UI) Review Strategy The Medical Advisory Secretariat used its standard search strategy to retrieve international health technology assessments and English-language journal articles from selected databases to determine the effectiveness and clinical utility of portable bladder ultrasound Case reports letters editorials non-systematic reviews non-human studies and comments were excluded Summary of Findings Studies examining the clinical utility of portable bladder ultrasound in the elderly population all found the device acceptable (1-4) including one study which reported that the device underestimated catheterized bladder volume Amongst 3 studies of portable bladder ultrasound devices in urology patients 2 of the 3 found the devices acceptable to use although Huang et al (5) did not find the devices as accurate for small PVR and Goode et al (6) found that they overestimated catheterized bladder volume In the remaining study by Alnaif and Drutz (7) the authors reported that because of misaimed scanheads there were missed bladders and that partial bladder volume measurements where lateral borders were missing resulted in the underestimation of PVR measurements They concluded that caution should be used in interpreting PVR from Portable bladder ultrasound machines and that catheterization may be the preferred assessment modality if an accurate PVR measurement is necessary

Three studies in post-operative populations all found Portable bladder ultrasound reasonably acceptable with 2 studies finding that the devices overestimated catheter derived bladder volumes by 7 (8)) and 21 ml(9) with the other study finding the opposite that the devices overestimated catheter bladder volume by 39 ml Two studies in rehabilitation settings found Portable bladder ultrasound to underestimate catheter derived bladder volumes yet both authors concluded that the mean errors were within acceptable limits(1011) Two studies in the neurogenic bladder population also found Portable bladder ultrasound to be an acceptable alternative to catheterization despite the fact that it was not as accurate as catheterization for obtaining bladder volumes Lastly in studies that examined negative health outcomes avoided unnecessary catheterizations were decreased by 20 to 47 and UTIs were decreased by 38 to 50 after the implementation of Portable bladder ultrasound(12-15) In sum all but one article advocated the use of Portable bladder ultrasound as an alternative to catheterization Policy Options Option 1 Recommend portable bladder ultrasound for use in complex continuing care and rehabilitation facilities for neurogenic bladder populations and in urology settings for UI assessment Option 2 Recommend portable bladder ultrasound for acute post-surgical care settings Data is not available for catheterized populations in hospital care settings and as such expected outcomes cannot be estimated reliably however hospitals should feel free to explore and evaluate the clinical utility of Portable bladder ultrasound use based on their populations needs Option 3 Do not recommend portable bladder ultrasound for the catheterized population in long-term care (LTC) Only 28 of all LTC residents are catheterized and at the institution level the purchase of this device would not be justified for so few patients (approximately 3 catheterized patients per facility) Option 4 Recommend portable bladder ultrasound for LTC for the purpose of prompted voiding Option 5 Recommend use of portable bladder ultrasound in community and home care settings It is difficult to comment on this option given the lack of literature on portable bladder ultrasound use in home care and community care settings and population catheterization rates and incontinence data as outcomes dependant on case mix served Portable bladder ultrasound should be used at own discretion

Abbreviations

95 CI 95 Confidence Interval AUA American Urological Association CCC Complex Continuing Care GAC Guidelines Advisory Committee HTPA Health Technology and Policy Assessment LTC Long Term Care PVR Post Void Residual SCI Spinal Cord Injury UI Urinary Incontinence UR Urinary Retention

In May 2005 the Continence Care Panel was formed to identify ways of integrating the continence care technologies reviewed by MAS (sacral nerve stimulation (SNS) and Tension-Free Vaginal Tape (TVT)) into the management pathways for continence in Ontario At the first meeting of the Panel in June 2005 it became clear that prior to incorporating SNS and TVT into the management of incontinence better consistency in the diagnosis prevention and the initial management of incontinence was required The Guidelines Advisory Committee (GAC) has prioritized continence care on its agenda and will work on the guidelines with members of the Continence Care Panel During the Continence Care Panel discussions it became apparent that there were other technologies used in the management of urinary conditions that were recommended for review by OHTAC These technologies include hydrophilic catheters bladder ultrasound and pessaries This health technology policy assessment (HTPA) will focus specifically on portable bladder ultrasound for use in clinical and community care settings by health professionals including long-term care rehabilitation and post-surgical acute care patients Other populations such as pediatric self-catheterizing and benign prostatic hyperplasia populations are beyond the scope of this HTPA Background

Clinical Need Target Population and Condition

Urinary incontinence (UI) is defined as any involuntary leakage of urine(16) Incontinence can be classified into diagnostic clinical types that are useful in planning evaluation and treatment The major types of incontinence are stress (physical exertion) urge (overactive bladder) mixed (combined urge and stress UI) reflex (neurological impairment of the central nervous system) overflow (leakage due to full bladder) continuous (urinary tract abnormalities) congenital incontinence and transient incontinence (temporary incontinence) (1718) Data from the National Population Health Survey indicate prevalence rates of urinary incontinence in the general population are 25 in women and 14 in men (19) Prevalence of UI is higher in women than men and prevalence increases with age (19) Identified risk factors for UI include female gender increasing age urinary tract infections (UTI) poor mobility dementia smoking obesity consuming alcohol and caffeine beverages physical activity pregnancy childbirth forceps and vacuum assisted births episiotomy abdominal resection for colorectal cancer and hormone replacement therapy(171818) The elements of UI assessment include a focused history and physical urinalysis post-void residual (PVR) and a void diary(18) Treatment for UI can be divided into behavioral management pharmacotherapy surgery and devices(18) PVR urine volume is the amount of urine in the bladder immediately after urination PVR urine volume is an important component in continence assessment and bladder management to provide quantitative feedback to both the patient and continence care team regarding the effectiveness of the voiding technique (20) Although there is no standardized universal agreed upon definition of normal PVR measurements of greater than 100 to 150 ml are an indication for intermittent catheterization whereas a PVR urine volume of 100 to 150 ml or less is generally considered an acceptable result of bladder training

Urinary Retention Urinary retention (UR) has been associated with poor outcomes including urinary tract infections bladder overdistension and higher hospital fatalities (2122) Overdistension following surgery under general anesthesia is probably the most common cause of acute urinary retention (12) In neurogenic populations UR may occur due to the loss of function in muscles and nerves in the urinary system UR can be silent and lower abdominal symptoms of acute UR may be masked in the elderly by analgesics or may not be perceived due to cognitive impairment Clinical examination of the abdomen is a notoriously unreliable method of detecting UR

The definition of UR based on the volume of PVR is somewhat arbitrary It depends on the population being studied or the clinically relevant condition Smith and Albazzaz (1996) defined UR where PVR was greater than 300 ml in a study of outcomes in elderly women undergoing surgery for proximal hip fracture(22) Diokno (1990) maintains one cannot establish a normal or pathologic value while most authors accept a figure of between 100-150 ml as being within the normal range(23) Clinically significant volumes may vary between a lower limit of 50 ml and an upper limit of 300 ml(224) The post void residual urine may vary in the elderly and may reflect lower urinary tract obstruction poor contractility or detrusor hyperactivity with impaired contractility (DHIC) or a combination of these entities (25)

Studies on varied populations have yielded no consensus regarding normal and abnormal PVR According to an extensive literature review by Borrie et al (2001) clinically significant post-void volumes varied between 50 ml and 300 ml (10) Most authors in the studies reviewed by the Medical Advisory Secretariat accepted volumes between 100 ml and 150 ml as normal While not all urethral catheterizations are unnecessary many catheterizations can be avoided Urinary retention can be assessed noninvasively by portable ultrasound (21026)The implementation of bladder ultrasound protocols will help caregivers determine when catheterization is necessary More research is required in order to better define pathologic urinary retention

Intermittent catheterization remains the gold standard for precise measurement of PVR volumes Catheterization especially after hip fracture post stroke or in the presence of cognitive impairment can be very challenging for nursing staff and uncomfortable for people with these conditions Portable bladder ultrasound offers a non-invasive painless method of estimating PVR urine and eliminates the risk of introducing urinary infection or causing urethral trauma by catheterization Previous research in various settings has supported portable handheld ultrasound scanners as non-invasive cost effective reliable and accurate for measuring PVR urine (1211252728)

Indwelling urinary catheters are often used for bladder drainage during hospital care Urinary tract infection is a common complication Other issues that should be considered when choosing an approach to catheterization are patients comfort other complicationsadverse effects and costs However patients report that catheterization is uncomfortable and humiliating (Personal communication January 2005) Furthermore costs are increased because each catheter is an expense and there is also increased demand on nursing time (15)

Indwelling urinary catheters are commonly used for bladder drainage during hospital care The most common complication is infection Urinary tract infections account for about 40 of hospital-acquired (nosocomial) infections (29) and about 80 of these are associated with urinary catheters Such infections not only prolong hospital stay and are expensive to treat but also cause unpleasant symptoms in patients life-threatening infections and shock When used in patients who are acutely ill the risk of a catheter-associated infection may be higher and hence pose a greater threat to life The first step in

reducing catheter-associated urinary tract infections and other complications is to avoid unnecessary catheterization the second is to remove the catheter as soon as possible

Portable ultrasound has been evaluated in several populations (126) It has been found to have an acceptable level of accuracy and may be considered an acceptable alternative to intermittent catheterization Elderly in Long-Term Care Settings Although the precise impact of normal aging on bladder function remains to be defined a number of physiologic changes have been described Bladder capacity urethral compliance maximal urethral closing pressure and flow rates all appear to decline in healthy continent women(25) Post-void residuals and involuntary detrusor contractions increase in both genders while urethral resistance increases in older men (25)

None of these factors alone or even in combination result in incontinence Nevertheless any of these may contribute towards the loss of continence in an otherwise vulnerable individual The vast majority of older individuals remain fully mobile even at an advanced age Nevertheless speed range and functional flexibility of locomotion are all reduced even in ostensibly healthy older individuals Such changes may for example impact the individuals ability to reach the bathroom following onset of urgency Moreover even relatively minor changes in visual perception and fine motor coordination may influence the removal of clothes and positioning in the bathroom

Daily fluid excretion pattern also changes with older individuals excreting a much larger proportion of their ingested fluid at night Sleep patterns are altered in aging with increased episodes of nocturnal awakening resulting in increased nocturia The risk of incontinence and falls at night is particularly great due to changes in lighting As well neuropsychologic and perceptual changes associated with transition from sleep to an awake state may also be problematic

Finally response to medication changes in old age This also occurs in healthy older individuals showing altered responsiveness to some medications and a greater risk of adverse reactions Anticholinergic medications represent a particular risk with a much greater risk of xerostomia constipation urinary retention and impaired cognition The percentage of body composition that is fat tends to increase while lean body mass decreases Thus the volume of distribution of lipid soluble drugs tends to increase while that of water-soluble compounds tends to decrease Decreased renal clearance of the latter category medications requires dose adjustments in many if not all older individuals

Urinary incontinence affects approximately half of nursing home residents ranging from a 40 to 70 prevalence rate Amongst Ontariorsquos 64 000 plus long-term care residents approximately 805 have reported constant incontinence and 89 have reported occasional incontinence 656 of LTC residents require daily car toileting (MOHLTC 2004) The prevalence of UR in LTC residents is approximately 9 Urinary retention in the elderly has been associated with poor outcomes including urinary tract infections bladder overdistension and higher hospital fatalities (21) Smith NKG 1996 248 id) UR can be silent and lower abdominal symptoms of acute UR may be masked in the elderly by analgesics or may not be perceived due to cognitive impairment The definition of UR based on the volume of a PVR is somewhat arbitrary Smith and Albazzaz (22) (1996) defined PVR greater than 300 ml in a study of outcomes in elderly women undergoing surgery for proximal hip fracture PVR urine volume may vary in the elderly and may reflect lower urinary tract obstruction poor contractility detrusor hyperactivity with impaired contractility (DHIC) or a combination of these entities(25)

In the elderly as part of investigation of incontinence Ouslander (1) has listed criteria for referral of elderly incontinent patients for urologicgynecological urodynamic evaluation A PVR urine of greater than 100 ml is one suggested indication for referral Neurogenic population Neurogenic bladder is a urinary problem in which there is abnormal emptying of the bladder with subsequent retention or incontinence of urine Depending on the type of neurological disorder causing the problem the bladder may empty spontaneously (incontinence) or may not empty at all (retention with overflow leakage) Neurogenic bladders may be caused by spinal cord injuries or brain trauma diabetes heavy metal poisoning acute infections or genetic nerve problems The prevalence of the population with neurogenic bladders is difficult to estimate similar to other incontinence-related statistics Symptoms of neurogenic bladder may include urinary incontinence urinary retention kidney damage kidney stones urinary tract infection absent or incomplete bladder emptying urinary frequency and urgency overflow incontinence and loss of bladder sensation Long-term consequences particularly upper tract damage and renal failure can contribute to premature death(30) Treatment for neurogenic bladder depends on the cause of the nerve damage the type of voiding dysfunction that results the patients medical profile severity of symptoms and a physicians recommendation Treatment options may include catheterization medication or artificial sphincters Intermittent catheterization is an important component of clinical management of neurogenic bladders through prevention of infection from incomplete or absent bladder emptying However intermittent catheterization puts patients at greater risk for UTI

Post-Surgical Urinary Incontinence

Overdistension (bladder contraction) following surgery under general anesthesia is probably the most common cause of acute urinary retention (31) The incidence of urinary retention following surgery varies with type of surgery sex age pre-operative urinary tract history medication and on type of anesthesia(9) The prevalence of post-operative UR ranges from 38 to 80 depending on the definition used and the type of surgery performed (32) One study in a population of post-operative gynecologic patients found a UR prevalence of 92 (32) Post-surgical patients with urinary retention are at risk of permanent detrusor damage

Prevention of urinary retention by catheter insertion may increase the risk of UTI Often patients receive intermittent catheterization prior to anesthesia administration to eliminate any urinary retention prior to surgery Intermittent catheters are also used to provide relief to individuals with an initial episode of acute urinary retention Indwelling urinary catheters are commonly used for bladder drainage during hospital care Alternatively surgical patients may receive a Foley catheter to empty the bladder prior to surgery to ensure increased space in the pelvic cavity to protect the bladder during pelvic abdominal surgery Indwelling catheters maintain a continuous outflow of urine for persons undergoing surgical procedures that cause a delay in bladder sensation

The most common complication of catheterization is infection Urinary tract infections account for about 40 of hospital-acquired (nosocomial) infections (29) and about 80 of these are associated with urinary catheters Such infections not only prolong hospital stay and are expensive to treat but also cause unpleasant symptoms in patients Sometimes the infection may threaten life by causing septic shock When used in patients who are acutely ill the risk of a catheter-associated infection may be higher and hence pose a greater threat to life

Existing Treatments Other Than Technology Being Reviewed

Catheters A catheter is a soft thin flexible tube which is inserted through the urethra to drain urine from the bladder PVR is removed with the placement of a catheter to decrease the build-up of urine in the bladder Large urine build-up is the cause of bladder infections urinary incontinence and permanent damage to bladder and kidneys Common problems associated with catheter management are

By-passing ie a leakage around the catheter Blocking of the catheter Discomfort in the urethra Bladder spasm Interruption of sexual activity Introducing bacteria into the urethra and bladder resulting in urinary tract infections and causing

fever and inflammation to the urinary tract Injury to the urethra caused by rough insertion of the catheter Narrowing of the urethra due to scar tissue caused by catheter insertion Injury to the bladder caused by incorrect insertion of the catheter Bladder stones usually after years of catheterization

Intermittent Catheterization The standard method of determining post-void residual urine volumes is intermittent catheterization which is associated with increased risk of urinary infection urethral trauma and discomfort for the patient After draining the bladder the catheter is removed as it is safer than leaving it intact Insertion of the catheter several times daily may decrease overdistension Intermittent catheterization may also be referred to as in-and-out catheterization The accuracy of in-and-out catheterization is considered the most accurate and readily available means of assessing bladder emptying In-and-out catheterization may be uncomfortable due to prostatic enlargement urethral stricture and bladder neck contracture in men and atrophic urethritis in postmenopausal women (1) Foley Catheter A Foley catheter is a closed sterile system inserted into the urethra to allow the bladder to drain Foley catheterization is usually used for individuals for whom other UI treatments have not been successful in patients who are impaired or where movement is painful or in patients with skin irritation or pressure ulcers Because it can be left in place in the bladder for a period of time it is also called an indwelling catheter It is held in place with a balloon at the end which is filled with sterile water to hold it in place The urine drains into a bag and can then be taken from an outlet device to be drained Laboratory tests can be conducted on urine to assess infection blood muscle breakdown crystals electrolytes and kidney function Risks with urinary indwelling catheterization include

Balloon does not inflate after insertion Balloon breakage during catheter insertion Balloon deflation Improper Foley placement causing stop of urine flow Urine flow blockage

Bleeding urethra Increased risk of infection with length of catheter in place Balloon opening during catheter insertion causing bleeding damage and even rupture of the

urethra Potential for long-term and permanent scarring of the urethra X-rays An X-ray using contrast dye may also be used to determine bladder volume and PVR This method is often not employed because the patient must fast prior to X-ray complex calculations are required to determine bladder volume and PVR X-rays are invasive where the patient is injected with contrast dye and X-rays involve radiation exposure Additionally the use of X-rays requires a trained operator and a radiologist to interpret the X-ray and determine the diagnosis Ultrasound Large Stationary Ultrasound Ultrasound-measured urine volume has been developed as a convenient non-invasive method of measuring bladder volume primarily PVR as an alternative to catheterization It is associated with less discomfort and potentially less risk of infection or trauma than catheterization and does not carry the hazards of radiation exposure from X-rays or complications associated with the use of a contrast medium The availability of a portable ultrasound machine may help alleviate some of the major drawbacks of larger ultrasound machines which include transport and scheduling constraints and the availability of trained sonographers Portable Ultrasound The use of portable ultrasound has many of the benefits of portable bladder ultrasound including its portability However its major drawback is that a real-time estimation of bladder volume and PVR are not provided The estimation of bladder urine volume and PVR using portable ultrasound would require additional time and training for calculating these volumes An additional step to calculate volumes would decrease the time available for estimating PVR and total bladder volume for other patients This would limit the utility of the portable ultrasound particularly in high volume settings where urine volume estimates are required several times daily and where large proportions of patients have UI such as in long-term and complex-continuing care environments

New Technology Being Reviewed

Portable bladder ultrasound products are portable ultrasound devices that use automated technology to digitally register bladder volume including post-void residual and provide 3-D images of the bladder The predominant clinical use of Portable bladder ultrasound is diagnostic where health professionals (predominantly nurses) administer the device to obtain PVR in order to prevent unnecessary catheterization Adjunctive functions can be utilized in order to visualize the placement and removal of catheters In addition to measuring PVR Portable bladder ultrasound products may also be used for the diagnosis and differentiation of urological problems for management and treatment including the establishment of voiding schedules bladder biofeedback reduction of UTI and in post-operative and trauma monitoring of potential UI

Portable bladder ultrasound devices are accurate reliable cost-effective and non-invasive (122627) The use of a bladder ultrasound device is appropriate when there is urinary frequency absent or decreased urine output bladder distention or inability to void after catheter removal and during the early stages of intermittent catheterization programs(28) McCliment et al discussed use of bladder ultrasound devices to help manage incontinence in nursing home patients(33) By monitoring fluid intake habits and using the scanner for 3 days staff members customized ldquocontinence care schedulesrdquo for each patient This has helped patients to recognize the sensations associated with bladder volumes and establish voiding patterns McCliment reports that bladder ultrasound devices have been used to assess the patency of indwelling catheters When urine output from an indwelling catheter decreases or when a patient has signs of urinary retention with a catheter in place the bladder scan device can be used to determine bladder volume In theory there should be minimal urine in the bladder if an indwelling catheter is in place High urine volumes may suggest that the catheter is occluded or positioned improperly

Portable bladder ultrasound devices are easy to use and well tolerated by patients Smith et al (24) offered step-by-step instructions for use of the BVI 3000 as one example of the bladder ultrasound First after the machine is turned on the operator indicates whether the patient is male or female After explaining the procedure the operator applies ultrasound gel to the hand-held transducer Next with the patient supine the transducer is placed 1 inch above the symphysis pubis pointing toward the bladder There is an icon of a person on the transducer and the head of the icon should be pointing toward the head of the patient Finally the transducer button is pressed to scan the bladder The device signals when the scan is complete and a picture of the bladder and an estimated volume appears on the screen Several scans can be done in order to obtain the best picture and most accurate assessment of the bladders volume

History

Since the introduction of ultrasounds machines in the 1950s they have been used to estimate various organ volumes Early studies of ultrasound measurement of PVR urine volume utilized large stationary ultrasound machines Using the large immobile ultrasound machines required separate calculation methods of total bladder volume and PVR urine volume Additionally it was often difficult to transport a patient across the hospital to a stationary ultrasound machine whereas portable ultrasound machines permit ultrasonography to be preformed bedside The cost of large portable ultrasound machines may also be limiting in comparison to the cost of a small portable ultrasound scanner particularly in settings where multiple scans are required Description Developments in the past several decades have led to advances in portable ultrasound machines Specifically portable ultrasound machines have been developed for the non-invasive measurement of

total bladder volume and PVR urine volume The portable bladder volume ultrasound machines consist of a hand-held ultrasound transducer (scanhead) and a base unit with a display screen (20) The transducer is placed on the patientsrsquo abdomen (suprapubic area) and aimed towards the bladder The portable ultrasound unit automatically calculates and displays the bladder volume There are several portable bladder ultrasound devices that produce an automatic output of bladder volume on the device display screen One newer device displays both a 3-dimensional image of the bladder area and an automatic calculation of bladder volume and in some models ultrasound-estimated bladder weight The Portable bladder ultrasound devices are specifically designed to measure residual urine volumes PBU have a measuring frequency of 2 MHz that has a scanning depth of up to approximately 20 cm The base unit of the Portable bladder ultrasound machine has an LCD screen which displays measured volume maximal volume measured and an aiming circle displaying the scanned bladder image to assist the device operator The LCD screen is attached to the scan head that is placed over the skin in the suprapubic region touching the ultrasound gel placed on the patientrsquos abdomen Facts on Benefits and Adverse Events Ultrasound may be preferred to manual palpation which is imprecise and catheterization the gold standard which is invasive Ultrasonography is safe as it avoids trauma to the urinary tract and risk of infection associated with catheterization both to the patient and attendant Using a Portable bladder ultrasound device also eliminates the need to calculate bladder volume formulas and may avoid unnecessary catheterization Additionally non-invasive biofeedback toileting trials and self-continence programs may be implemented based on Portable bladder ultrasound measurements of urine volume and PVR Lastly as Portable bladder ultrasound is a non-invasive portable device patient transfer is not necessary and patient comfort and dignity are improved The costs associated with implementing Portable bladder ultrasound are offset by savings in nurse time catheterization equipment laundering and medical imaging Table 1 Advantages of Using Portable Bladder Ultrasound Advantages of Portable bladder ultrasound bull Readily acceptable by patients bull Non-invasive bull Less uncomfortable bull Less risk for infection and trauma bull Risk free as regards to radiation or reaction

to medium bull Easy to use thus readily acceptable by staff bull Faster than in-and-out catheterization bull New computerized ultrasound devices

require no mathematical calculation Clinical Applications of Portable bladder ultrasound bull Bladder scanning is indicated as a component of all continence assessments bull Bladder scanning can be combined with a symptom profile to assess the need for mechanical

bladder emptying such as intermittent self-catheterization vibration or other methods bull To provide biofeedback to patients with urgency and to help with bladder retraining by

demonstrating the small volumes causing symptoms

bull To check for residual urine which may indicate an obstructive voiding pattern bull To identify level of bladder sensation related to bladder volume bull To evaluate if a patient is able to void and to what degree following a trial without catheter bull To assess the degree of retention and whether further investigation or intervention is necessary bull To assessmonitor clients on anticholinergic medication to ensure the medication has not induced a

voiding problem Morbid obesity severe abdominal scarring ovarian cysts fluid-filled structures in the pelvis greater than 2 cm pregnancy muscle spasms abdominal herniation and abdominal breathing may interfere with bladder ultrasound scanning and prevent accurate measurements (2030) Potential adverse effects of Portable bladder ultrasound use may include skin irritation allergic reaction to ultrasound gel and padding and pressure sore formation at the site of sensor placement(30) There are no contraindications for using Portable bladder ultrasound devices but informed consent must be obtained and health care workers must be trained on the use of the device Additional precautions to undertaking a Portable bladder ultrasound include recognizing that patients with urinary incontinence may find gentle probe pressure uncomfortable and that the machine battery should not be on charge Regulatory Status Several Portable bladder ultrasound devices are currently licensed for use in Canada (Appendix 1) The Diagnostic Ultrasound Corporation is the only company licensed to provide sale of portable ultrasound machines with automated bladder volume measurements in Canada BardScan (34) and Bladder Manager (35) are two other portable ultrasound devices that provide an automated readout of bladder volume OHIP Funding Currently physicians may bill for measurement of post-void residual under the Ontario Schedule of Benefits This may be performed in office using an ultrasound or through catheterization Catheterization and Portable bladder ultrasound use are also in the scope of practice of nurses as they are measurement and treatment tools OHIP Billing does not apply to nurses and therefore the costs of performing PVR measurement is represented in their hourly wage or salary Current Use Currently both nurses and physicians alike use Portable bladder ultrasound in many facilities Often urologists gerontologists and gynecologists are the physician specialties most likely to use Portable bladder ultrasound Nurses in post-operative units obstetric-gynecology units long-term care home-care rehabilitative complex-continuing care and general practice use Portable bladder ultrasound Portable bladder ultrasound instruments are often purchased through operating budgets of individual institutions and departments During the Improving Continence Care in Complex Continuing Care IC5 project aimed at improving continence care in Ontario complex continuing care facilities twelve institutions purchased Portable bladder ultrasound instruments for implementation and evaluation in continence care nursing practice (Personal Communication February 2006)

Literature Review on Effectiveness

Objective To assess the clinical utility of portable bladder ultrasound Questions Asked

1) What is the sensitivity and specificity of Portable bladder ultrasoundtrade in measuring PVR a In what populations

2) What is the utility of Portable bladder ultrasound in prevention a Catheterizations avoided b Urinary tract infections avoided c Discontinued catheter use d Reducing catheter-related damage to the urinary tract e Reducing incontinence episodes as an outcome of bladder trainingprompted voiding

3) What are the harms of Portable bladder ultrasound 4) What is the effect of Portable bladder ultrasound use on quality of life 5) What is the nursing preference for Portable bladder ultrasound use

Methods The Medical Advisory Secretariat completed a computer-aided search limited to English-language studies in humans Case reports letters editorials non-systematic reviews and comments were excluded (Appendix 2) Inclusion and exclusion criteria were applied to the results according to the criteria listed below Each article was critically appraised for quality using Jaeschkersquos (36) and Greenhalghrsquos (37) criteria for evaluating diagnostic studies (Appendix 3) Inclusion Criteria English-language articles Journal articles that reported primary data on the effectiveness or cost-effectiveness of data obtained in a clinical setting or analysis of primary data maintained in registries or databases Study design and methods that were clearly described Systematic reviews randomized controlled trials (RCTs) non-RCTs or cohort studies that had gt20 patients and cost-effectiveness studies Relevant populations (ie not healthy volunteers) Device licensed by Health Canada Exclusion Criteria Duplicate publications (superseded by another publication by the same investigator group with the same objective and data) Non-English language articles Non-systematic reviews letters and editorials Animal and in-vitro studies Case reports

Studies that did not examine the outcomes of interest Subjects not population of interest or did not describe the population of interest (ie healthy volunteers) Intervention Use of Portable bladder ultrasound Comparator Urinary catheterization No use of Portable bladder ultrasound for voiding trials and prompted voiding Incontinence episodes Literature Search Cochrane database of systematic reviews ACP Journal Club DARE INAHTA EMBASE MEDLINE Reference sections from reviews and extracted articles Outcomes of Interest Sensitivity and specificity of portable bladder ultrasound Effect of portable bladder ultrasound use in diagnosis between different types of UI Effect of Portable bladder ultrasound use with catheterizations avoided Effect of Portable bladder ultrasound use with discontinued catheter use Effect of Portable bladder ultrasound use with UTIs avoided Effect of Portable bladder ultrasound use with catheter-related damage to urinary tract Effect of Portable bladder ultrasound use with self-toileting outcomes of bladder training Effect of Portable bladder ultrasound use with incontinence episodes avoided Effect of Portable bladder ultrasound use with voiding trials voiding schedules and biofeedback outcomes Effect of Portable bladder ultrasound use on quality of life Effect of Portable bladder ultrasound use with nursing preference Harms of Portable bladder ultrasound

Results of Literature Review

Table 2 Quality of Evidence of Included Studies RCT refers to randomized controlled trial daggerg indicates grey literature

Study Design Level of Evidence

Number of Eligible Studies

Large RCT systematic reviews of RCT health technology assessments

Large RCT unpublished but reported to an international scientific meeting

1(g)dagger 0

Small RCT 2 0Small RCT unpublished but reported to an international scientific meeting

2(g) 0

Non-RCT with contemporaneous controls 3a 17Non-RCT with historical controls 3b 0Non-RCT presented at international conference 3(g) 0Surveillance (database or register) 4a 0Case series (multisite) 4b 0Case series (single site) 4c 0Retrospective review modeling 4d 0Case series presented at international conference 4(g) 0

Summary of Findings of Literature Review After scanning the literature search results 17 articles were considered relevant to the MAS review Articles were found with regards to the clinical utility of Portable bladder ultrasound in elderly urology rehabilitation post-surgical and neurogenic bladder patients along with data on episodes of catheterizations avoided reduction in catheterizations and subsequent UTI with implementation of Portable bladder ultrasound There were no RCTs found in the literature review on Portable bladder ultrasound Several of the study questions were not addressed by studies found in the literature review and were not included in the Medical Advisory Secretariat analysis Summary of Existing Health Technology Assessments

In 1996 the Alberta Heritage Foundation for Medical Research (AHFMR) completed an HTA on the use of bladder ultrasound scanning for the measurement of PVR in comparison to intermittent catheterization in patients with neurological disorders following stroke or spinal cord injury (20) Based on the four diagnostic studies reviewed AHFMR concluded that bladder ultrasound was not as accurate as intermittent catheterization in measuring PVR however bladder ultrasound was effective in measuring clinically relevant levels of PVR The HTA concluded that bladder ultrasound was much easier and faster to perform than catheterization but requires standardized training protocols for care staff Summary of Controlled Diagnostic Experiments Prospective Clinical Series Geriatric Medicine Patients and Long-Term Care Facility Patients A community-based study by Ouslander et al (1) assessed the clinical utility of Portable bladder ultrasound in 201 consecutive incontinent nursing home residents who were participating in a larger clinical trial PVR measurements were obtained using the Portable bladder ultrasound model BVI 2000 or the BVI 2500 from 3 trained staff members and then compared with the gold standard in-and-out catheterization The accuracy of the Portable bladder ultrasound was calculated in comparison to the volume obtained via catheterization This study took place over a period of three years Most ultrasound measurements of bladder volume were made using the BVI 2000 During the course of the study the BVI 2500 was developed and the newer device was used for 61 of the subjects The results obtained using the BVI 2500 were highly correlated with those obtained using the older model (range r2 087 to 090) The ultrasound demonstrated excellent test-retest (range r2 097 to 098) and inter-rater reliability (range r2

092 to 094) For low PVR the device was highly sensitive (r2 =90 for PVR lt50 ml and r2 = 95 for PVR lt100 ml) and moderately specific (r2 71 for PVR lt 50 ml and r2 63 for PVR lt 100 ml) For PVR of more than 200 ml (n = 26) the ultrasound had a sensitivity of 69 and a specificity of 99 Portablebladder ultrasound was highly sensitive and moderately specific for low volumes of PVR and was moderately specific and highly specific for high PVR volumes (Table 3) Due to the low sensitivity of Portable bladder ultrasound (069) in high PVR repeated measurements may be needed to exclude high PVR in some individuals Their investigators concluded that the portable ultrasound device may also be useful in the nursing home setting

Table 3 Accuracy of Portable Bladder Ultrasound for Various PVR Levels in Incontinent Nursing Home Residents (Ouslander et al 1994) (1) PVR from Intermittent Catheterization Sensitivity Specificitylt 50 ml (n=70) 09 071lt 100 ml (n=118) 095 063gt 100 ml (n=68) 063 095gt 150 ml (n=37) 059 097gt 200 ml (n=26) 069 099

A prospective study in the geriatric medicine department of a Singapore hospital (n=80) investigated the clinical utility of Portable bladder ultrasound (BVI 2500) (4) One hundred Portable bladder ultrasound measurements were first made by one investigator and then compared to corresponding catheterization volumes taken by blinded hospital medical staff (doctor or nurse) In the first 20 cases a single Portable bladder ultrasound reading was taken In the subsequent 80 cases 2 Portable bladder ultrasound PVR measurements were performed to investigate whether the accuracy of the Portable bladder ultrasound could be further improved upon PVR volumes ranged from 5 to 1150 ml Accuracy in PVR volumes greater than 100 ml was 89 and accuracy in PVR volumes greater than 200 ml was 86 The K values obtained for the agreement on whether PVR volumes were greater than 100 ml or 200 ml were 078 and 076 respectively In the 80 cases where 2 Portable bladder ultrasound readings were performed the absolute errors were +54 ml (SD 81) and +55 ml (SD 86) respectively indicating that 2 PVR measurements did not result in measurement improvements The Pearson co-efficient of variation was 096 for pairs of Portable bladder ultrasound and catheterized PVR measurements Analysis of the 100 Portable bladder ultrasound measurements did not reveal any statistically significant findings with regards to increased accuracy with increasing experience with the Portable bladder ultrasound device (P =21) Study investigators concluded that Portable bladder ultrasound was reasonably accurate and was recommended in routine use for the measurement of PVR Urology Patients One study among older urology outpatients (n=249) in the United States was prospectively evaluated by first using Portable bladder ultrasound (BVI 2500) and then catheterization for comparison by two independent observers(2) Portable bladder ultrasound and catheter volumes were correlated (r2=090 Plt001) across the range of 0 to 1015 cc On average the Portable bladder ultrasound underestimated catheter volume by 10 cc in men and 20 cc in women Using the cut-point of 100 cc or greater the Portable bladder ultrasound 2500 had a sensitivity of 97 a specificity of 91 with an overall accuracy of 94 The 1994 BVI 2500 model was used for 81 of the accuracy studies and 101 were conducted using the 1995 model Portable bladder ultrasound BVI 2500+ in order to test inter-device variability The accuracy of the 2 machines was compared with no significant differences found Inter-rater reliability between the 2 observers was performed the 2 observers one a physician and the other a graduate physician had achieved similar volume determinations (r2=090 Plt001) Eleven patients had a Portable bladder ultrasound reading of 0 In these patients with 0 readings corresponding catheter volumes ranged from 0 to 55 cc with a mean volume of 215 cc In the 17 patients with Portable bladder ultrasound readings between 0 and 50 cc catheter volumes ranged from 10 to 94 cc with a mean of 374 cc Therefore in null or very low bladder volume outputs it may be that Portable bladder ultrasound readings may reflect either accurate or underestimated bladder volume readings Lastly patient characteristics (age sex height weight diagnosis uterine presenceprostate size or user experience) were analyzed and did not impact the accuracy of the Portable bladder ultrasound Study investigators concluded that Portable bladder ultrasound was an accurate and reliable device for adult outpatient bladder volume

measurement A prospective study by Huang et al(5) investigated the accuracy of Portable bladder ultrasound in comparison to a traditional stationary ultrasound device in the measurement of PVR Sixty-four patients (37 men 27 women) with voiding dysfunction referred for PVR measurement from April to September 2001 were included in the study Patient diagnosis included spinal cord injury (n=23) stroke (n=32) traumatic brain injury (n=6) and other conditions (n=3) In sequence PVR measurements were taken by the Portable bladder ultrasound (BVI 3000) stationary ultrasound and then by the gold standard catheterization volume Three examiners performed the 3 measurements separately and were blind to one anotherrsquos results The mean operating time was 449 plusmn188 seconds for Portable bladder ultrasound 1037plusmn 341 seconds for stationary ultrasound and 2772 plusmn890 seconds for catheterization The mean absolute errors were 344 ml (695 plt05) for Portable bladder ultrasound and 219 ml (166 plt05) for the stationary ultrasound when correcting for examination interval time (1 mlminute) (Table 4) Portable bladder ultrasound and stationary ultrasounds had sensitivities of 8049 and 8696 and the specificities of 9024 and 100 respectively In a subgroup analysis based on bladder volume (ml) determined by catheterization there was a significant increase in accuracy with the Portable bladder ultrasound device from Group I (less than or equal to 100 ml bladder PVR volume) with a percentage error of 661 plusmn 762 to Group II (101-300 ml bladder PVR volume) with a percentage error of 202 plusmn 187 With regards to Group III (301-500 ml PVR) and Group IV (gt500 ml PVR) there was insufficient power to detect any significant differences (Table 5) The authors concluded that portable ultrasound might not provide as an accurate measurement of PVR particularly with small bladder volumes in comparison to stationary Portable bladder ultrasound Table 4 Comparison of Mean Absolute Error and Mean Percentage Error of Portable bladder ultrasound and Stationary Ultrasonography (Huang et al 2004)(5)

Ultrasound Equipment

Stationary Ultrasound P-value

Mean Absolute Error 344 plusmn 382 219 plusmn 250 Plt05 Mean Percentage Error 36 plusmn 524 131 plusmn 105 Plt005

Table 5 Sub Group Comparison of Different Bladder Volume Levels (Huang et al 2004)(5) Stationary Ultrasound Portable bladder ultrasound

Bladder Volume Group n

Catheterized Bladder Volume

(ml) Absolute Error

(ml) Percentage Error ()

Absolute Error (ml)

Percentage Error ()

le 100 ml 23 614 plusmn 245 79 plusmn 78 129 plusmn 78 254 plusmn 258 661 plusmn 762 101 - 300 ml 32 1690 plusmn 472 253 plusmn 205 148 plusmn 115 298 plusmn 289 202 plusmn 187 301 - 500 ml 7 4143 plusmn 614 309 plusmn 226 69 plusmn 40 754 plusmn 729 168 plusmn 139 gt 500 ml 2 8500 plusmn 707 995 plusmn 658 101 plusmn 55 690 plusmn 523 77 plusmn 57

Goode et al (6) assessed the clinical utility of BladderScanreg (BVI 2500) in 95 community-dwelling women ages 32-92 who sought treatment for urinary incontinence Study participants underwent an interview physical examination pre- and post-void Portable bladder ultrasound and urethral catheterization for PVR Initial ultrasound volume for PVR was significantly correlated with catheterized volume (r2 = 60 Plt 001)) but was significantly larger than average catheterized volume (mean difference 17ml Plt 0001 95 CI 8 25 ml) Only 9 participants had elevated PVR volumes greater than

or equal to 100 ml on catheterization On Portable bladder ultrasound only 6 of the 9 patients PVR measurements were gt100 ml for a sensitivity of 667 Specificity of the Portable bladder ultrasound device for PVR ge100 ml was 965 The authors concluded that the Portable bladder ultrasound was quick easy to use reasonably sensitive and very specific for determining elevated PVR A study by Alnaif and Drutz (1999) examined the accuracy of Portable bladder ultrasound (BVI 2500) in a population of 80 women undergoing uroflowmetry in an urodynamic unit in Toronto Ontario (7) Ultrasound PVR measurements were performed immediately prior to urinary catheterization Catheterized PVR was considered the gold standard and the Portable bladder ultrasound reading was considered accurate if it was within 25 of the PVR obtained from catheterization Readings from bladder volumes below 50 ml correlated poorly with actual PVR derived from catheterization (606 correlation) Ultrasound readings of lsquo000rsquo were obtained 35 times (44) and corresponding catheter obtained volumes ranged from 5 to 170 ml Of the 35 null Portable bladder ultrasound readings 85 had a corresponding catheter measurement volume of less than 50 ml but 3 of the null Portable bladder ultrasound readings had catheter-measured PVR volumes ge 100 ml a clinically significant indicator for catheterization In further analysis women with null Portable bladder ultrasound readings were not significantly different from other patients with regards to BMI and height which are hypothesized to affect Portable bladder ultrasound accuracy The large variability in differences between catheterized and Portable bladder ultrasound PVR was a statistically significant difference using the Wilcoxian signed-rank test (Plt001) Only 3875 of the Portable bladder ultrasound measurements were within 25 of the actual catheterized PVR Assessing accuracy as the difference between catheterized and Portable bladder ultrasound PVR as less than 25 or less than 20 ml for readings of lsquo000rsquo the Portable bladder ultrasound had 606 accuracy in PVR lt50 ml (n=33) 27 accuracy in detecting PVR of 50-150 ml (n=36) and 10 accuracy in detecting residuals gt150 ml (n=10) (Table 6) The authors concluded that because of misaimed scanheads there were missed bladders and partial bladder volume measurements where lateral borders were missing producing underestimated PVR measurements They concluded that caution should be used in interpreting PVR from Portable bladder ultrasound machines and that catheterization may be the preferred assessment modality if an accurate PVR measurement is necessary Table 6 Accuracy of Portable bladder ultrasound in detecting PVR at different PVR volumes within 25 of catheterized volume (Alnaif amp Drutz 1999)(7)

PVR volume N Accuracy lt50 ml 33 6060 50-150 ml 36 2700 gt150 ml 10 1000

Post-Operative and Acute Care Patients In a validation trial of Portable bladder ultrasound (BVI 2500) Brouwer et al (8) investigators used a sample of 60 healthy volunteers and 50 patients (ages 18-80) scheduled to undergo surgeries requiring anesthesia and catheterization The results from the 50 healthy volunteers were excluded from this Medical Advisory Secretariat review Pre- and post- induction of anesthesia ultrasound measurements were recorded and then followed by catheterization for measurement of true urinary volume for the surgical sample The Portable bladder ultrasound bladder volume measurements underestimated true bladder volume by 7 across the total volume range of 17 ml to 970 ml Underestimation of PVR was greater in females than in males (Plt02) The correlation of Portable bladder ultrasound volume to catheter volume was r2 = 094 in awake patients (Plt01) and r2=095 in anesthetized patients (Plt01) Bland and Altman analysis indicated a bias of 19 ml in patients with a precision of 80 ml for Portable

bladder ultrasound An evaluation of body length and weight by BMI found no significant differences in PVR measurement in either male or female surgical patients (Plt05) Rosseland et al (9) compared BladderScan BVI 2500+ readings in comparison to catheterized PVR volumes in 36 patients who underwent spinal anesthesia and were monitored in a post-anesthesia care unitThe 13 nurses working in the post-anesthesia care unit were given 5 to 10 minutes training on the operation of Portable bladder ultrasound Portable bladder ultrasound bladder volume measurements were compared to catheter obtained volumes The mean difference between Portable bladder ultrasound and catheterization estimates was -215 ml (95 CI -147 +104 ml) using Bland and Altman statistical techniques Hence on average Portable bladder ultrasound underestimated bladder volume by 215 ml Study investigators concluded that there was good agreement between Portable bladder ultrasound and catheter estimates of bladder volume The use of portable bladder ultrasound (BVI 2500) was studied in a sample of 40 consecutive women undergoing laparoscopy(38) Prior to surgery the study patients were given the opportunity to void pre-operatively Following the induction of general anesthesia PVR estimates were obtained using Portable bladder ultrasound The same operator performed all scans If estimated bladder volume was ge100 ml urinary catheterization was performed prior to surgery and true PVR volume was recorded Of the 40 women 14 had estimated PVR greater than 100 ml (range 101-445 ml) as obtained by Portable bladder ultrasound and were catheterized The true PVR obtained by catheterization had a range of 47 to 370 ml In 5 women PVR was less than 100 ml In all but one woman scanning overestimated the PVR Using Bland and Altman methods the mean overestimated volume was 39 ml (95 CI -13 85 ml) Investigators concluded that use of Portable bladder ultrasound may eliminate unnecessary catheterizations and felt that a mean error of 39 ml was acceptable of recorded bladder volume was over 100 ml However due to study design limitations Portable bladder ultrasound estimated volumes under 100 ml were assumed accurate and no true PVR was obtained from catheterization Slappendel et al (12) sought to determine if the use of portable bladder ultrasound to measure bladder volume reduced the number of catheters used and the incidence of UTI among patients who underwent elective orthopedic surgery at a hospital in the Netherlands Portable bladder ultrasound) was used prospectively in an attempt to reduce the need for catheterization of the urinary bladder and the incidence of urinary tract infections after orthopedic surgery Over a 4-month period in which 1920 patients were included catheterization was performed if there was no spontaneous diuresis by 8 hours after surgery A total of 31 of these patients were catheterized and 18 patients developed urinary tract infections In a subsequent 4-month period there were 2196 patients catheterization was performed only if the bladder volume was more than 800 ml 8 hours after surgery as determined by portable bladder ultrasound The rate of catheterization decreased to 16 and 5 patients developed urinary tract infections Reductions in the number of patients catheterized and the number of UTI were statistically significant using the Wilcoxian signed rank test (Plt05)(Table 7) The authors concluded that measuring patient bladder volume reduced the need for a urinary catheter and the likelihood of urinary infection However there were limitations to the study Catheterization guidelines at the institution had changed from the pre-Portable bladder ultrasound period to more stringent guidelines for catheterization when Portable bladder ultrasound was introduced into the hospital and fewer patients underwent surgery with anesthesia post-Portable bladder ultrasound introduction which may have decreased the risk of UR by a small amount

Table 7 Results from a Study in an Orthopedic Surgery Unit Before and After Introducing BladderScan Slappendel et al (12)

Period before Portable bladder

ultrasound measurement

Period with Portable bladder ultrasound

measurement Number of patients 1920 2196 Number of catheters used 602 349 Percentage of patients who were catheterized 3140 1590 Number of UTI 18 5 Plt05

In a study by Moore and Edwards (13) investigators described the implementation of Portable bladder ultrasound and rates of UTI reduction and then reported the expenditures and cost-savings attributable to Portable bladder ultrasound Over a 12 month period 2 units in a Maryland hospital were selected to have bedside assessment of bladder volumes in place of intermittent catheterization Over the 12-month study period 805 Portable bladder ultrasound procedures were performed Only 22 of the patients scanned with the device required catheterization and the hospital had a 50 decrease in UTIs Additionally investigators found the Portable bladder ultrasound device to be more accurate with smaller bladder volumes correlating to the amount of urine drained via catheterization The cost of UTI incidence was estimated at $680 USD and the costs to perform each catheterization ranged from $525 to $1635 USD (excluding practitionerrsquos wages) Given the savings realized from a reduction in treating UTI Moore and Edwards Moore 1997 87 id suggested that one portable bladder device needed to be used 200 times in order to recover the purchase cost ((list price purchased at $8300 USD) However a formal economic analysis was not included in the study and cost analysis was based on author opinion

Rehabilitation Patients Borrie et al Borrie 2001 47 id examined UR in geriatric rehabilitation unit patients (n=167) and assessed the prevalence and risk factors of UR including an investigation of Portable bladder ultrasound (BVI 2500) validityThe prevalence of UR was defined as PVR greater than or equal to 150 ml in two consecutive measurements Estimates were confirmed by ldquoin and outrdquo catheterization for true volumes of PVR for the 19 residents that had a PVR greater than 150 ml Individuals that did not have 2 consecutive PVR measurements of greater than 150 ml were not catheterized In the frail elderly population UR prevalence was 11 with the risk of UR greater for older patients patients on anticholinergic medication patients with a long-term history of diabetes or patients with fecal impaction Scan volumes underestimated catheterization volumes by 808 plusmn 1113 ml (Plt001) The correlation between paired scans and catheter volumes of ge150 ml was 087 The results suggest that the BladderScan BVI 2500+ ultrasound scanner when used by trained nursing staff provides conservative and valid estimates of PVR ge150 ml in people undergoing geriatric rehabilitation Lewis et al (28) conducted an observational study on Portable bladder ultrasound (BVI 2500) implementation at a rehabilitation facility They measured post-void residual volume as part of a standard assessment of patients bladder function to determine patient needs with regards to bladder emptying ability and a secondary objective of portable bladder ultrasound implementation was its effect on urinary catheterization rates in patients Facility staff was trained and used Portable bladder ultrasound to measure PVR The percentage of patients with orders for catheterization decreased from 80 to 60 following the

implementation of the ultrasound program Sixty-eight (79) of post-void residuals done by bladder ultrasound found volumes of 100 cc or less and catheterization was avoided for these patients The volume found in 48 out of 72 post-void residual catheterizations was too low to justify catheterization

Resnick et al (25) evaluated the effectiveness of Portable bladder ultrasound (BVI 2000) in the assessment and treatment of urinary incontinence and in training older adults in a geriatric unit and an acute rehabilitation unit to regain bladder function after the removal of an indwelling Foley catheter All participants in the study were over 65 years of age Over a 3-month period the 16 patients in the study had 95 scans performed The patients bladders were scanned with every spontaneous void or every 8 hours until PVR was 300 cc or less Individuals with residual urine volumes of greater than 300cc were catheterized Of the 95 scans performed in this study only 50 resulted in a patient being catheterized 8 patients were catheterized because of PVR greater than 300 cc Consequently 45 (47) of the scans resulted in patients not being catheterized following the scan Study investigators reported a decrease in UTI rates UTI was present in 50 of patients at admission and in 12 at discharge No study protocol was in place to examine the effect of Portable bladder ultrasound on UTI rates The nurses learned the scanning procedure quickly after an initial demonstration and a single practice assessment The nurses reported informally that the scans were quick and easy to do The patients reported satisfaction at not having to endure catheterizations unless they were necessary Additionally study authors reported that use of the scanner probably reduces hospital costs by decreasing the number of catheterizations reducing nursing time and contributing to a reduction in UTI However the authors did not provide any evidence of cost-savings Neurogenic Bladder Patients Residual urine volumes of 24 men with neurogenic bladder dysfunction were repetitively assessed 400 times with the BVI-2000 Portable bladder ultrasound device prior to 100 episodes of intermittent catheterization(11) By comparing each examiners first ultrasonographic measurement of urine volume with the catheterized urine volume the mean error of the ultrasonographic measurements was -26 ml (-11) and the mean absolute error was 44 ml (22) The ultrasonographic measurements detected the presence of residual urine volumes of ge100 ml with a sensitivity of 90 and a specificity of 81 In the subset of catheterization episodes in which the catheterized urine volumes were le 200 ml the mean error of the ultrasonographic measurements was -15 ml (-9) the mean absolute error was 37 ml (28) and the sensitivity and specificity were 77 and 81 respectively There was no advantage in using the average or maximum of 2 repeated ultrasonographic measurements over using each examiners first ultrasonographic measurement alone Increased examiner experience did not significantly decrease the errors encountered Ireton et al (39) evaluated Portable bladder ultrasound (BVI 2000) in a population of patients from a hospital urology clinic a hospital spinal cord injury unit and cystoscopy clinic patients from a Veterans hospital All patients required PVR measurement for standard clinical indications Exclusion criteria included extreme obesity or abdominal scarring All investigators had completed a minimum of 10 supervised Portable bladder ultrasound estimates prior to the study Every patient had 4 Portable bladder ultrasound measurements completed by 2 different investigators all within a 10-minute interval All patients had the bladder emptied by either cystoscopy or catheterization The correlation co-efficient between Portable bladder ultrasound-estimated PVR and catheterized PVR was r2 =079 Measurements in men were more accurate than in women (r2=082 versus r2=053) and in spinal cord injury patients in comparison to other patients (r2 =075 versus r2= 068) However they were not statistically significant at the 005 level The 2 investigators with the most experience with the device had a better correlation with

catheterized volume than other investigators (r2=084 versus r2 =060) but they were both on the spinal cord injury team which may have biased the results and elevated their correlation with the catheterized volumes Study investigators concluded that although Portable bladder ultrasound design needs improvement it is an alternative to urethral catheterization for determination of bladder volume in most patients Fakhri et al (40) evaluated the use of Portable bladder ultrasound (BVI 3000) in 39 male spinal cord injury patients in a Kuwait rehabilitation hospital Of the patients participating in the trial 21 patients had hyperreflexic bladder and 18 patients had hyporeflexic bladder Bladder Scan was performed immediately prior to catheterization The mean difference between Portable bladder ultrasound and catheterization PVR volume was -29plusmn7 ml in the Hyperreflexic bladder group and -47plusmn11 ml in the Hyporeflexic bladder group There was no significant difference of PVR measured by Portable bladder ultrasound and catheterization in both groups of patients (Pgt05) Study investigators concluded that Portable bladder ultrasound results are reliable with good correlation to results of urethral catheterization Summary of Observational Studies

Studies examining the clinical utility of Portable bladder ultrasound in the elderly population all found portable bladder ultrasound acceptable including one studyrsquos results that found Portable bladder ultrasound to underestimate catheterized bladder volume (1) Marks LS 1997 241 id (4) Of three Portable bladder ultrasound studies in urology patient populations 2 found Portable bladder ultrasound acceptable to use despite each study reporting device shortcomings Huang et al (5) found Portable bladder ultrasound to be less accurate than catheterization particularly for small PVR volumes and another Goode et al (6) reported that that Portable bladder ultrasound overestimated catheterized bladder volume In the third study by Alnaif and Drutz (7) the authors concluded that because of misaimed scanheads there were missed bladders and partial bladder volume measurements where lateral borders were missing producing underestimated PVR measurements They concluded that caution should be used in interpreting PVR from Portable bladder ultrasound machines and that catheterization may be the preferred assessment modality if an accurate PVR measurement is necessary Three studies in post-operative populations all found Portable bladder ultrasound reasonably acceptable with 2 studies finding that the devices overestimated catheter derived bladder volumes by 7 (8)) and 21 ml with the other study finding the opposite that the devices overestimated catheter bladder volume by 39 ml (9) Two studies in rehabilitation settings found Portable bladder ultrasound to underestimate catheter derived bladder volumes yet both authors concluded that the mean errors were within acceptable limits (1011) Two studies in the neurogenic bladder population also found Portable bladder ultrasound to be an acceptable alternative to catheterization despite the fact that it was not as accurate as catheterization for obtaining bladder volumes Lastly in studies that examined negative health outcomes avoided unnecessary catheterizations were decreased by 20 to 47 and UTIs were decreased by 38 to 50 after the implementation of Portable bladder ultrasound(12-15) There were several limitations that applied to the majority of studies There were no randomized controlled trials Randomization may have been appropriate in examining health outcomes such as reductions in catheterizations and UTI rates However randomization would not have been appropriate with regards to the studies examining sensitivity and specificity as an appropriate pattern of work-up in

an individual is required in diagnostic study design A majority of studies did not include details of training protocols with regards to null Portable bladder ultrasound readings and catheterization procedures nor was there mention of training individuals using the Portable bladder ultrasound in some studies Additionally very few studies utilized blinding between the Portable bladder ultrasound measured bladder volume or PVR and the corresponding catheterization derived bladder volume or PVR One of the major flaws in the literature was the inappropriate use of statistical methods Bland and Altman (41) point out that in the comparison of 2 measurement methods measuring the same quantity the statistical concept of limits of agreement would be more appropriate than the correlation co-efficient The Bland Altman Test measures how close the agreement is whereas correlation co-efficients measure the degree of association between the 2 measurement methods Hence studies investigating the clinical utility of Portable bladder ultrasound should use the Bland Altman Plot method (41) Additionally the majority of the studies provided conclusions regarding the utility and effectiveness of Portable bladder ultrasound without a priori definition of appropriate levels of either clinical utility (eg sensitivity and specificity) or in reductions of negative health outcomes such as unnecessary catheterization and UTI Medical Advisory Secretariat Review

Models of Portable bladder ultrasound Devices Currently there are several models of Portable bladder ultrasound in use and licensed by Health Canada but the only products licensed are BladderScan machines The only manufacturer of these devices is Diagnostic Ultrasound Corporation Two studies addressed the use of different Portable bladder ultrasound models BladderScan models BVI 2000 BVI 2500 and BVI 2500+ were evaluated as newer models of the device and were introduced during the study time periods The BVI 2000 compared favorably to BVI 2500 in the first study by Ouslander et al (1) deriving similar results to correlations with catheter volume and in the second study y Marks et al (2) BVI 2500 and BVI 2500+ also obtained similar readings to catheter volumes In the study by Ouslander et al (1) Portable bladder ultrasound BVI 2000 was compared to the BVI 2500 a newer model at the time Study Observer 1 tested 61 pairs on 2 occasions with both models and found a correlation co-efficient of r2=089 for both tests Study Observer 2 found a correlation of r2=087 for the first test on 61 pairs and a correlation of r2=090 for test 2 using 60 pairs Both observed results indicate little variation between Portable bladder ultrasound models BVI 2000 and BVI 2500 In a study by Marks et al (2)(1999) the 1994 and 1995 Portable bladder ultrasound models BVI 2500 and BVI 2500+ respectively were examined Using linear regression they predicted catheter volume from Portable bladder ultrasound volume with the BVI 2500 correlating to scan volume r2=093(SD 42) and BVI 2500+ correlating to scan volume r2=093(SD 40) There were minimal differences between the BVI 2500 and BVI 2500+ in predicting catheter volume Inter-Rater Reliability Inter-rater reliability was evaluated in 3 studies with relatively similar results between raters Ouslander et al (1) compared Observer 1 to Observer 2 in 2 tests using 143 pairs in the first test with a correlation of r2=092 in and a correlation of r2=094 in 142 pairs in test 2 concluding excellent inter-rater reliability In a study by Marks et al (2) a graduate physician and a college student achieved similar volume determinations (r2=090) Study protocol in Ireton et al (39) included performing at minimum 10 supervised Portable bladder ultrasound measurements prior to completing any Portable bladder ultrasound measurements for the study The 2 investigators with the most experience had better correlations with

catheter volumes (r2=084 and r2=083) in comparison to the other investigators (r2=060) However the 2 more experienced investigators were also on the spinal cord catheterization team with some difference potentially accounted to measuring men with mostly neurogenic bladders and whose Portable bladder ultrasound measurements were more closely related to actual catheter volume measurements than other study subjects Repeated Measures Five studies included consecutive Portable bladder ultrasound measurement in individual patients They found that repeated measurements did not improve the accuracy of Portable bladder ultrasound as correlated to catheterization volume In the Ireton et al(39) (1990) study 4 Portable bladder ultrasound measurements were completed on each patient by 2 different examiners Investigators found that taking the first measurement compared to the average of 4 measurements did not diminish correlation to catheter volume (r2=079 to r2=076) Ouslander et al (1994)(1) completed approximately 4 measurements on each subject and used the average of the first 2 measurements when presenting sensitivity and specificity but did not report outcomes across the 4 consecutive PVR measurements made with Portable bladder ultrasound Ding et al(4) (1996) completed 1 Portable bladder ultrasound measurement on the first 20 subjects in their study and then 2 consecutive Portable bladder ultrasound measurements in the subsequent 80 study participants to determine if accuracy could be further improved The first measurement alone had an absolute error of 54 ml and an absolute error of 55 ml when the average of 2 measurements was taken indicating no benefit of multiple scans In a study of 24 men with neurogenic bladders 400 measurements were made and authors reported that there was no clear advantage in using the average or maximum of 2 Portable bladder ultrasound measurements over using the examinerrsquos first measurement alone (11) In a study that took 3 Portable bladder ultrasound measurements investigators used the highest reading rather than average or random readings because it provided the highest correlation to catheterized bladder volume (r2=090 Plt001)(2) However all 3 readings did correlate with catheter volume and each other (all r2gt085 Plt001) Null Readings Two studies examined the null bladder volume measurements made by Portable bladder ultrasound Marks et al(2)(1997) looked at a subgroup of 11 patients with Portable bladder ultrasound readings of 0 and catheter volumes ranged from 0 to 55 cc In the 17 patients where scan volumes were greater than 0 but less than 50 cc corresponding catheter volumes ranged from 10 to 94 cc Low Portable bladder ultrasound readings including null readings in this study were predictive of low catheter volume The authors concluded that the underestimates in scan volumes may be due to continued bladder filling during the delay before catheterization and after Portable bladder ultrasound or the failure of the scan to include all parts of the bladder (2) In another study of female urology outpatients Portable bladder ultrasound readings of lsquo000rsquo were obtained 35 times (44) and corresponding catheter obtained volumes ranged from 5 to 170- ml (7) Of the 35 null Portable bladder ultrasound readings 85 had a corresponding catheter measurement in volumes of less than 50 ml but 3 of the null Portable bladder ultrasound readings had PVR volumes of over 100ml a clinically significant indicator for catheterization In further analysis women with null Portable bladder ultrasound readings were not significantly different from other patients with regards to BMI and height which are hypothesized to affect Portable bladder ultrasound accuracy The large variability in the difference between catheterized and Portable bladder ultrasound PVR was statistically significant using the Wilcoxian signed-rank test (Plt 001) Sensitivity and Specificity Portable bladder ultrasound is highly sensitive and moderately specific for low volumes of PVR and moderately specific and highly specific for high PVR volumes (Table 8) Reported sensitivities ranged from 067 to 090 and reported specificities ranged from 063 to 097

Table 8 Sensitivity and Specificity of Portable bladder ultrasound measured to Catheterization Volume

Reference

Portable bladder ultrasound Population n

Cutoff Value Sensitivity Specificity

Ouslander et al 1994(1)

BVI 2000 BVI2500 Nursing Homes

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

Marks et al 1997(2) BVI 2500 BVI 2500+ Urology Patients

ge 100 cc 097 091

Huang et al 2004(5) BVI 3000 Urology Patients 64

ge 100 ml 08 087

Goode et al 2000(6) BVI 2500 Urology Patients 95

ge 100 ml 067 097

Revord et al 2003(11) BVI 2000

Neurogenic Bladder 24

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Mean Error Estimates The mean error the difference between the bladder volumes derived from Portable bladder ultrasound and that of the catheter was included in several studies (Table 9) Portable bladder ultrasound both over- and underestimated catheter obtained bladder volume Table 9 Mean Error Differences between Portable bladder ultrasound and Catheterization

Reference

Portable bladder ultrasound Setting n

Mean Volume Difference Estimate

Marks et al 1997(2)

BVI 2500 BVI 2500+

Older Urology Patients 249 -152 plusmn 4 cc

Goode et al 1990(6) BVI 2500

Urology Patients 95 17 ml (95CI 8 25 ml)

Rosseland et al 2002(9) BVI 2500+

Post-Operative Patients 36

-215 ml (95CI -147 104 ml)

Moselhi et al 2001(38) BVI 2500

Post-Operative Females 40 39 ml (95CI -13 85 ml)

Brouwer et al 1999(8) BVI 2500

Surgical Patients 50 -31 plusmn 55 ml (Pgt05)

Fakhri et al 2002(40) BVI 3000

-29 plusmn 7 ml (Plt05) hyperreflexic bladder

-47 plusmn 11 ml (Plt05) hyporeflexic bladder

Borrie et al 2001(10) BVI 2500 Rehabilitation 167 -806 plusmn 1112 (Plt001)

Sub Group Analysis Three studies investigating the clinical utility of Portable bladder ultrasound found differences with regards to accuracy of the device in certain sub-populations In a study by Marks et al(2) Portable bladder ultrasound underestimated true bladder volume by 10 cc in men and 20 cc in women One study in a population of patients from a hospital urology clinic a hospital spinal cord injury unit and cystoscopy clinic patients from a Veterans hospital found slight differences in the accuracy of Portable bladder ultrasound in women and spinal cord injury groups (39) Measurements in men were more accurate than in women (r2=082 versus r2=053) and in spinal cord injury patients in comparison to other patients (r2 =075 versus r2= 068) However they were no studies statistically significant at the 005 level Fakhri et al (40) evaluated Portable bladder ultrasound in 39 male spinal cord injury patients in a Kuwait rehabilitation hospital They found the mean difference between Portable bladder ultrasound and catheterization PVR volume was -29plusmn7 ml in the hyperreflexic bladder group and -47plusmn11 ml in the hyporeflexic bladder group Catheterization and UTI Avoided Four studies included outcomes related to reduction of catheterization and UTI with the implementation of Portable bladder ultrasound (Table 10) Unnecessary catheterizations avoided ranged from 16 to 47 in the selected articles Reductions in UTI ranged from 38 to 72 In the study by Slappendel et al (12) there was a statistically significant reduction in catheterizations and UTIs due to the pre- and post-study design of the trial (Plt 05) Often a patient is catheterized upon suspicion of UR The proportion of scanned patients who received catheterization ranged from 16 to 53 indicating a potential relationship between the implementation of Portable bladder ultrasound with reductions in catheterizations and subsequent UTI Table 10 Health outcomes of Portable bladder ultrasound implementation Number of

Scans Catheters Avoided UTI Reduction of Scanned

Patients Catheterized

Resnick et al1995 (25) Geriatric Rehabilitation

Lewis et al1995(28) Rehabilitation

72 20 NR 33

Slappendel et al 1999(12) Orthopedic Post-Surgical Unit

2196 159 Plt05

72 Plt05

Moore and Edwards 1997(13) Acute Hospital

805 NR 50 22

Summary of Medical Advisory Secretariat Review

Acceptable levels of clinical utility Not as accurate as catheterization but non-invasive and therefore other benefits

Highly sensitive and moderately specific for low volumes of PVR and moderately specific and highly specific for high PVR volumes Reported sensitivities ranged from 067 to 090 and reported specificities ranged from 063 to 097

Good levels of inter-rater reliability given training and standardization with Portable bladder ultrasound

Repeated consecutive measurements do not significantly improve Portable bladder ultrasound reading correlation to true bladder volume measurement as derived from catheterization

In sub-group analysis is less accurate for woman than in men Spinal cord injury patients also exhibited higher levels of accuracy than other acute care and rehabilitative patients

Unnecessary catheterizations avoided ranged from 16 to 47 in the review articles Reductions in UTI ranged from 38 to 72 Significant findings in reducing negative health outcomes

Economic Analysis

Results of Literature Review on Economics

In the literature bladder ultrasound devices have been estimated to cost from $8300 to $10000 (131524) Recent studies have outlined cost-benefit analyses used when considering the purchase of a Portable bladder ultrasound device by an institution In a cost-analysis by Moore and Edwards UTI incidence was $680 USD and the costs to perform each catheterization ranged from $525 to $1635 USD (excluding practitionersrsquo wages) (13) Given the savings realized from a reduction in treating UTI Moore and Edwards Moore 1997 87 id suggested that one portable bladder device needed to be used 200 times in order to recover the purchase cost However a formal economic analysis was not included in the study and cost analysis was based on author opinion Philips et al Philips JK 2000 251 id described one facilitys attempt to decrease nosocomial urinary tract infections and the associated cost analysis Prior to implementing their UTI Reduction Project they estimated the yearly cost of nosocomial UTIs to be $17 million A portion of this program encouraged the use of a bladder ultrasound protocol after indwelling catheter removal In the month prior to the introduction of the bladder ultrasound protocol 118 intermittent catheterizations were performed in the rehabilitation unit One month after the protocol only 2 intermittent catheterizations were performed Supply savings alone were estimated at $2784 yearly If 1392 catheterizations were avoided yearly then approximately 27 nosocomial UTIs may also be avoided potential savings were estimated at $45900 for 1 year Frederickson et al (15) also offered a brief cost analysis of a bladder ultrasound protocol in orthopedic and surgical units They estimated the BVI 2500reg to cost $8300 and treatment costs for nosocomial UTIs to be $680 for each incident They concluded that the supply cost saved after 2280 avoided catheterizations would recover the cost of the device in about 29 years However when considering the cost of UTIs it would take only 12 avoided infections to recover the cost of the device

Wooldridge et al (42) clearly outlined the information required for a comprehensive cost analysis when comparing intermittent catheterizations and bladder ultrasound devices Data to be considered for intermittent catheterization included the number of catheterizations yearly number of times a measurement of bladder volume is required time required for catheterizations associated labor costs supply costs UTI rates and UTI treatment and medication costs However Wooldridge directed this information to long-term care facilities and did not include the costs of extended hospital stays which would need to be considered in acute care settings According to Wooldridge these costs should be compared to the costs associated with bladder ultrasound use that include the number of times a measurement of bladder volume is required time spent scanning and labor costs associated with scanning She also noted that catheterization labor costs must be calculated using licensed personnel wages The final step would be to compare approximate savings to the cost of the device Training to use a scan involves a 10-minute video which describes operation is available online from Diagnostic Ultrasound Ontario-Based Economic Analysis

Notes and Disclaimer

The Medical Advisory Secretariat uses a standardized costing methodology for all of its economic analyses of technologies The main cost categories and the associated methodology from the provincersquos perspective are as follows Hospital Ontario Case Costing Initiative (OCCI) cost data is used for all program costs when there are 10 or more hospital separations or one-third or more of hospital separations in the Ministryrsquos data warehouse are for the designated International Classification of Diseases-10 diagnosis codes and Canadian Classification of Health Interventions procedure codes Where appropriate costs are adjusted for hospital-specific or peer-specific effects In cases where the technology under review falls outside the hospitals that report to the OCCI PAC-10 weights converted into monetary units are used Adjustments may need to be made to ensure the relevant case mix group is reflective of the diagnosis and procedures under consideration Due to the difficulties of estimating indirect costs in hospitals associated with a particular diagnosis or procedure the Medical Advisory Secretariat normally defaults to considering direct treatment costs only Historical costs have been adjusted upward by 3 per annum representing a 5 inflation rate assumption less a 2 implicit expectation of efficiency gains by hospitals Non-Hospital These include physician services costs obtained from the Provider Services Branch of the Ontario Ministry of Health and Long-Term Care device costs from the perspective of local health care institutions and drug costs from the Ontario Drug Benefit formulary list price Discounting For all cost-effective analyses discount rates of 5 and 3 are used as per the Canadian Coordinating Office for Health Technology Assessment and the Washington Panel of Cost-Effectiveness respectively Downstream cost savings All cost avoidance and cost savings are based on assumptions of utilization care patterns funding and other factors These may or may not be realized by the system or individual institutions In cases where a deviation from this standard is used an explanation has been given as to the reasons the assumptions and the revised approach The economic analysis represents an estimate only based on assumptions and costing methods that have been explicitly stated above These estimates will change if different assumptions and costing methods are applied for the purpose of developing implementation plans for the technology Diffusion Currently the bladder scanners in Ontario are funded through global hospital and long-term care facility budgets According to the manufacturer of the BladderScan devices (Personal Communication Diagnostic Ultrasound Corporation February 2006) 128 bladder scanners were purchased by acute care

facilities 84 by long term care facilities 10 by urologists 3 by nurse practitioners 11 by private nursing companies and 2 by individuals in Ontario from December 2003 to December 2005(Personal communication date) This economic analysis focuses on the potential cost savings that would result if the Portable bladder ultrasound technology were adopted for the 15 complex continuing care (CCC) facilities within Ontario The total cost of a bladder scanner as reported by the manufacturer is $19566 per device This includes a 5-year manufacturerrsquos warranty scanner insurance training video manuals software upgrades online viewing and printing of images online calibration and 12-month exam storage Demographics The prevalence of urinary incontinence is estimated at 25 for women and 14 in men in the general population (19) Economic analysis was not completed in acute care community and home care and long-term care population settings Data was not available for either catheterization rates or for the effectiveness of Portable bladder ultrasound on relevant health outcomes in these populations Table 11 Urinary Incontinence and Catheter Use in Ontario

7Urinary Incontinence and Catheter use in Ontario

unknown

Urinary Incontinence Prevalence

~65000 residents in ON

~1000000 admissions per

12 million Ontario

residents

Population

26 (unknown how many associated

with catheterization)

25 -- all types of catheters (unknown

of intermittent cath)

Long-term Care Homes

unknown

19-90 -- all types of catheters

(unknown of intermittent cath)

Complex Continuing Care

~35000 per year (unknown how many associated

unknown (UHN purchased

12700 intermittent cath in 200405)

Acute Care

unknown

Rate of intermittent catheterizationHealth sector Rate of UTI

unknown (purchased ~ 46000 intermittent cath in

200405)

Community Care Access Centres

(CCAC)

In the fiscal year 2003 the total population of patients in complex continuing care facilities was estimated at 30360 for all 15 CCC facilities in Ontario which averages at 2024 patients per CCC facility per year (43)The average length of hospital stay for a CCC facility patient was 53 days (PHPDB) The average daily population of a typical CCC facility was calculated based on the average length of hospital stay Total number of patients in a CCC facility = (2024 patients 53 days)365 days = 294 patients Of the 294 patients per CCC facility per day approximately 17 (50 patients) would be classified as

those requiring catheter care (Personal communication February 2006) Therefore a total of 50 patients per CCC facility would benefit from the adoption of the bladder scanner Economic Model

The figure below illustrates a typical CCC facility decision analytic model to estimate cost savings

Figure 1 Economic model for a complex continuing care facility

Approximately 17 of the population in an average CCC facility would be classified as those requiring daily catheter care (Personal communication February 2006) The figure above summarizes the path taken for one instance of catheter care with and without the adoption of bladder scanner technology In the scenario where the bladder scanner is employed a registered nurse would scan the patient to determine PVR A patient with a PVR measurement greater than 150ml indicating urinary retention would be catheterized On the other hand a patient with a PVR measurement less than 150 ml would not be catheterized leading to a decrease in ldquounnecessary catheterizationsrdquo Borrie et al (10) estimated the probability of a PVR measurement greater than 150 ml to be approximately 11 per patient while Wu et al (44) and Tam et al(45) estimated the probability at 215 and 218 respectively An average of these estimates (181) was used in the economic model for this HTPA In the scenario with no bladder scanner adoption each patient would be catheterized regardless of urinary retention In each instance of catheterization the probability of urinary tract infection (UTI) is 5 (46) According to expert opinion a patient would be scanned approximately 4 times daily to determine PVR measurements and whether catheterization is necessary Therefore each scenario would repeat itself 4 times at the end of each path to represent typical daily PVR assessments and catheterization procedures in a CCC facility For example in the scenario with the adoption of the bladder scanner if a patient were to follow the top most path heshe would be initially scanned and catheterized (assuming a PVR measurement gt150ml) and then develop a UTI Six hours after this assessment the patient would be scanned again and the progression within that model would depend on the PVR measurement and whether the patient developed a UTI On the other hand in the no bladder scanner scenario the patient would be catheterized every 6 hours and progression within the model would depend on whether the patient developed a UTI in each instance of catheterization For each unique path within the economic model the path probability was determined as well as the total expected cost per facility per day the expected number of catheterizations per facility per day and

expected number of UTIs per facility per day This was done to estimate expected net costs to a CCC facility and the total number of catheterizations and UTIs avoided due to adopting the Bladder Scanner Costs All costs are in Canadian currency unless otherwise noted Ontario Case Costing Initiative (OCCI) data was unavailable for the CCI and ICD-10 codes in relation to urinary incontinence and catheterizations Since nurses would typically use the bladder scanner for PVR measurements within complex continuing care facilities and due to a lack of physician codes billed nursing time and cost of catheters were used to cost catheterization procedures Similarly nursing time was used to cost each instance that a bladder scan was conducted The average time spent by a nurse for a bladder scan was estimated at 075plusmn03 min while the average time spent by a nurse on a catheterization was estimated at 46plusmn15 min (47) The average cost of 10 days of oral antibiotic treatment was used to cost UTIs which was estimated at $1718 per UTI (average of a ten day regime of Bactirim Amoxil and Macrobid) The average cost of a registered nurse in Ontario is $2980hour (Personal Communication Ontario Nurses Association April 2006) Cost Calculations Estimated cost for a bladder scan 2980(00125) = $037 Average cost of a catheter is $150 Total cost per catheterization is $150 + 2980(00769 hours) = $379 The economic model revealed that approximately 169 catheterizations and 1 urinary tract infection (UTI) were avoided daily in a typical CCC facility The total annual expected cost per CCC facility with the bladder scanner was estimated at $24 per CCC facility per day while the total annual expected cost per CCC facility without the bladder scanner was estimated at $679 per CCC facility per day The difference in costs is mostly attributable to the decrease in the number of catheterizations with the adoption of the bladder scanner technology The total annual cost to a CCC facility (including catheter costs nurse time and UTI treatment costs but excluding device costs) was estimated at $35770 with the adoption of the bladder scanner technology Without the adoption of the bladder scanner technology the cost to a typical CCC facility was estimated at $247835 Budget Impact Analysis In order to estimate the total budget impact and cost to the Ontario Ministry of Health and Long Term Care device costs were factored into the above costs Total first year cost with Bladder Scanner per facility $55336 (= $35770+$19566) Total first year cost without Bladder Scanner per facility $247835 Net first year cost per facility $192499 in savings Net first year cost for 15 CCC facilities = $2887485 in savings

Since the cost of the bladder scanner is a one-time cost to each CCC facility after the first year an additional savings of $19566 would occur each year Existing Guidelines for Use of Technology

Post-Void Residual Measurement The Canadian Urological Association In June 2005 the Canadian Urological Association voted in guidelines on urinary incontinence(48) ldquoAdult patients with a history of urinary incontinence should undergo a basic evaluation that includes a history physical examination evaluation of post-void residual volume and urinalysishellipEstimation of PVR volume is better done by catheterization or pelvic ultrasound hellipResidual volume (repeat test of high residual volume) of 50 to 100 ml is considered ldquoacceptablerdquo but in any case clinical history and circumstances would have to be analyzedrdquo The American Urological Association Optional tests are those that are not required but may aid in the decision-making process When the initial evaluation suggests a nonprostatic cause for the patients symptoms or when the patient selects invasive therapy the physician may consider additional diagnostic testing if the results of the test(s) are likely to change the patients management or more precisely predict the benefits and risks of the selected treatment The 1994 Agency for Health Care Policy and Research (AHCPR) guideline suggested that the physician consider performing one or more optional diagnostic tests prior to offering treatment options to the patient (49) In some cases additional diagnostic tests may aid in the selection of an invasive treatment that is best for an individual patient (eg identification of prostate middle lobe) Optional Following the initial evaluation of the patient urinary flow-rate recording and measurement of PVR may be appropriate These tests usually are not necessary prior to the institution of watchful waiting or medical therapy However they may be helpful in patients with a complex medical history (eg neurological or other diseases known to affect bladder function or prior failure of BPH therapy) and in those desiring invasive therapy Large PVR volumes (eg 350 ml) may indicate bladder dysfunction and predict a slightly less favorable response to treatment In addition large PVRs may herald progression of disease Still residual urine is not a contraindication to watchful waiting or medical therapy Because of large test-retest variability and a lack of appropriately designed outcome studies it is not feasible to establish a PVR cut-point for decision making The Panel considered the use of PVR measurements optional in men undergoing noninvasive therapy based on the observation that the safety of noninvasive therapy has not been documented in patients with residual urine (200 to 300 ml) In some studies however residual urine has predicted a high failure rate of watchful waiting Within the range of residual urine values from 0 to 300 ml the PVR does not predict the response to medical therapy Although long-term controlled data is lacking many patients maintain fairly large amounts of residual urine without evidence of UTI renal insufficiency or bothersome symptoms Therefore no level of residual urine in and of itself mandates invasive therapy

AppraisalPolicy Development

Policy Implications Patient Outcomes ndash Medical Clinical Introduction of the Portable bladder ultrasound into various care units would likely be associated with improved UI-related outcomes in patients As outlined in the evidence-based analysis using the Portable bladder ultrasound device to measure PVR will likely result in identifying a clinically significant PVR volume that may avoid unnecessary catheterization and subsequent UTI Implementation of the Portable bladder ultrasound device may also result in saved nursing time for facility staff from avoiding catheterizations thereby creating additional care time available to patients Ethics Use of the Portable bladder ultrasound device should be restricted to trained health care professionals such as medical doctors and nurse who have undergone training for the use of the device Portable bladder ultrasound usage may be advantageous to the patient as it may avoid catheterizations which are invasive and may lead to UTI Moreover using Portable bladder ultrasound may also be advantageous in preserving patient dignity Demographics Several thousand Ontario residents would benefit from Portable bladder ultrasound This number of Ontarians that would benefit from the technology would be difficult to quantify as incontinence prevalence and incidence are grossly under reported However long-term care and complex continuing care institutions would greatly benefit from Portable bladder ultrasound as would numerous rehabilitation post-surgical care units and urology clinics Diffusion ndash International National Provincial Rapid diffusion of Portable bladder ultrasound technology is expected Recently the IC5 project on improving continence care in Ontario complex continuing care centres piloted Portable bladder ultrasound in 12 sites Preliminary results were promising for the technology (Personal communication January 2006) Numerous physicians and health care facilities already have Portable bladder ultrasound devices in use However the use of Portable bladder ultrasound devices for PVR measurement is not in use in the majority of health care facilities in Ontario and Canada Additionally the use of a PVR measurement is not incorporated into all regular continence care procedures The importance of a PVR should be incorporated into assessment of UI and once fully diffused and incorporated in standard UI assessment and care the diffusion of Portable bladder ultrasound devices is set to increase However the Diagnostic Ultrasound Corporation (DXU) patents BladderScan which is currently the sole licensed manufacturer of the portable bladder ultrasound in Canada Field monopoly may influence the rising costs of Portable bladder ultrasound particularly when faced with rapid expansion of the technology Several hundred Portable bladder ultrasound devices have been sold in Canada since the early 1990s when Portable bladder ultrasound was first introduced in to the market Sales data from the Portable bladder ultrasound manufacturer indicate an increase in the number of units being purchased (Table 11) In Ontario several individual institutions have purchased the bulk of Portable bladder ultrasound products(Table 12) Research project funding and acute care hospital employees transition to working from home have also been other notable sources of increases in purchases Lastly additional units have

been purchased from the Ministry of Health and Long Term Care Standards on Continence Care in Long- Term Care facilities (Personal Communication Diagnostic Ultrasound Corporation March 2005) Table 12 Portable bladder ultrasound Sales in Canada by Year and Model 1999-2005 (Diagnostic Ultrasound Corporation 2006)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

BVI6400BVI6300BVI6200BVI6100PCI5000RPCI5000BVI5000RBVI5000BVI3000DBVI3000UBVI3000RBVI3000BVI2500UBVI2500

Table 13 Portable bladder ultrasound Sales December 2003 to December 2005 by Facility Type (Diagnostic Ultrasound Corporation 2006)

Sector Units Purchased

Acute Care 128

Long Term Care 84

Urologists 10

Nurse Practitioners 3Private Nursing Company (VON Comcare etc) 11

Individuals 2 Cost The cost of the Portable bladder ultrasound devices range from $17 69890 to $19 56595 total purchase price per unit as quoted by the manufacturer Diagnostic Ultrasound Corporation Additional training packages batteries and battery chargers software gel pads and yearly warranties are at an additional cost Studies have indicated that Portable bladder ultrasound is a cost-effective technology due to cost-

avoidance of catheterization equipment nursing time and reductions in catheter-related complications and urinary tract infections (1517) Stakeholder Analysis Licensed health care professionals such as nurses and physicians use Portable bladder ultrasound devices in patients with UI Catheterizations and UTIs may be avoided through use of the technology therefore healthcare professional may save timeand cost-savings will be realized Physician visits may be avoided with the measurement of PVR at the home facility as well as follow up visits to the physician for damage caused to the urinary tract by catheterizations and UTI avoided Moreover there is a health care provider preference for the non-invasive Portable bladder ultrasound instead of performing catheterization The major costs associated with the implementation of Portable bladder ultrasound in a health facility will be the purchase costs of the device itself Facility administrators will be affected by the costs of the device Additionally health professionals using the device will need to calibrate the machine and send the device for yearly tune-ups depending on the model of Portable bladder ultrasound used This will also include additional warranty costs as well as costs associated with the time needed for training battery and gel pads costs to be incorporated into yearly budgets The use of Portable bladder ultrasound device will affect the patient directly in terms of health outcomes In addition to avoiding trauma related to the urinary tract from catheterization and avoiding UTIs there is a patient preference for using Portable bladder ultrasound as to preserve their dignity System Pressures The primary system pressures will occur in budgeting and the diffusion of the Portable bladder ultrasound device Currently funding constraints have prevented some facilities and units from purchasing the Portable bladder ultrasound machine (Personal Communication January 2006) In addition although PVR measurement is included in the physician fee schedule for general assessments in urology visits it is not currently in widespread use during urological examinations by family physicians (Personal Communication January 2006) There is the potential for Portable bladder ultrasound use in prompted voiding Two case reports to date have found success in using Portable bladder ultrasound for prompted voiding(3350) Given that 68 of over 30000 LTC patients currently require assisted toileting and over 80 are incontinent the implications would impact several thousand Ontarians and thus should be considered The implementation of the device may result in decreased incontinence episodes potential saved costs and savings to nursing time required for toileting assistance while increasing patient dignity (Personal communication date) The Canadian Continence Foundation held 7 reactor panels across Canada including Ontariorsquos metropolitan rural and mid-size areas Through the reactor panelsrsquo discussions on continence care in Canada several system-level themes emerged Most notably access to continence care was a major theme and easily reflects system pressures with regards to Portable bladder ultrasound implementation in Ontario Several unmet continence care needs that may affect Portable bladder ultrasound implementation include access to continence care provision of and availability of instruments and knowledge of their proper application (eg ldquoPortable bladder ultrasound to assess manage urinary retention voiding-diary methodrdquo) billing practices disincentive to continence care and follow-up funding as a carrier to services uninsured specialized health professionals such as continence care nurses and physiotherapists the shortage in medical specialists and long waiting lists for referral services

Policy Options

Option 1 Recommend portable bladder ultrasound for use in complex continuing care and rehabilitation facilities for neurogenic bladder populations and in urology settings for UI assessment Option 2 Recommend portable bladder ultrasound for acute post-surgical care settings Data is not available for catheterized populations in hospital care settings and as such expected outcomes cannot be estimated reliably however hospitals should feel free to explore and evaluate the clinical utility of Portable bladder ultrasound use based on their populations needs Option 3 Do not recommend portable bladder ultrasound for the catheterized population in long-term care (LTC) Only 28 of all LTC residents are catheterized and at the institution level the purchase of this device would not be justified for so few patients (approximately 3 catheterized patients per facility) Option 4 Recommend portable bladder ultrasound for LTC for the purpose of prompted voiding Option 5 Recommend use of portable bladder ultrasound in community and home care settings It is difficult to comment on this option given the lack of literature on portable bladder ultrasound use in home care and community care settings and population catheterization rates and incontinence data as outcomes dependant on case mix served Portable bladder ultrasound should be used at own discretion

Appendices

Appendix 1

Appendix 1 Portable bladder ultrasound Devices Licensed by Health Canada

First First First

Lic Device Class

Issue Date License Name

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

PORTABLE BLADDER ULTRASOUND BVI3000 NONINVASIVE BLADDER VOLUME INSTRUMENT

6272001 PORTABLE BLADDER ULTRASOUND BVI 3000

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

DIAGNOSTIC ULTRASOUND CHARGER CRADLE

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

DIAGNOSTIC ULTRASOUND COMMUNICATION CRADLE

1182002 COMMUNICATION CRADLE

1182002 0570-0156

61755 3 262003

BVI PORTABLE BLADDER ULTRASOUND

262003 PORTABLE BLADDER ULTRASOUND BVI 6100 SCANNER

262003 0570-0154

9172004 BVI 6200 PORTABLE BLADDER ULTRASOUND

9172004 0570-0160

63380 3 1292003

BLADDERMASS BVM 6500 1292003 PORTABLE BLADDER ULTRASOUND BVM 6500

1292003 0570-0159

63850 3 2242004

PORTABLE BLADDER ULTRASOUND BVI 6300 - NON INVASIVE BLADDER VOLUME INSTRUMENT

2242004 0570-0161

65809 3 9142004

MOBILE PORTABLE BLADDER ULTRASOUND BVI 6400 - NON INVASIVE BLADDER VOLUME INSTRUMENT

9142004 MOBILE PORTABLE BLADDER ULTRASOUND BVI 6400 SCANNER

9142004 0570-0273

68889 2 7212005

FLOPOINT UROFLOW SYSTEM 7212005 FLOPOINT UROFLOW SYSTEM - COMMUNICATION CRADLE

7212005 0570-0168

7212005 FLOPOINT UROFLOW SYSTEM - FLOSENSOR

7212005 0570-0175

7212005 FLOPOINT UROFLOW SYSTEM - FLOSENSOR CHARGER

7212005 0570-0176

7212005 FLOPOINT UROFLOW SYSTEM - MAIN UNIT

7212005 0270-0292

7212005 FLOPOINT UROFLOW SYSTEM - SCANPOINT DOCKING STATION

7212005 0270-0300

7212005 FLOPOINT UROFLOW SYSTEM - SCANPOINT REMOTE ACQUISITION HANDSET

7212005 0570-0174

Appendix 2

Bladder Ultrasound ndash Search Strategies - Final Search date December 14 2005 Databases searched OVID Medline In Process and Other Non-Indexed Citations Embase Cochrane DSR and CENTRAL INAHTA Database Ovid MEDLINE(R) lt1966 to November Week 3 2005gt Search Strategy -------------------------------------------------------------------------------- 1 (Portable bladder ultrasound or bladder scan or bardscan or bladderscan)mp [mp=title original title abstract name of substance word subject heading word] (46) 2 exp BLADDERus [Ultrasonography] (686) 3 exp Urinary Retentionus [Ultrasonography] (67) 4 exp Urinary Incontinenceus [Ultrasonography] (225) 5 or2-4 (851) 6 exp Bladder or exp Urinary Retention or exp Urinary Incontinence or exp Urinary Catheterization (52802) 7 exp Ultrasonography (156634) 8 6 and 7 (988) 9 (mobile or portable or automated or scan or scanner or bedside)mp [mp=title original title abstract name of substance word subject heading word] (179095) 10 exp Point-of-Care Systems (2371) 11 (5 or 8) and (9 or 10) (193) 12 1 or 11 (211) 13 limit 12 to (humans and english language) (171) 14 limit 13 to (meta analysis or review academic or review tutorial) (9) 15 (systematic review$ or meta-analysis or metaanalysis)mp [mp=title original title abstract name of substance word subject heading word] (21596) 16 13 and (14 or 15) (9) 17 13 (171) 18 limit 17 to (case reports or comment or editorial or letter or review or review literature or review multicase or review of reported cases) (31) 19 17 not 18 (140) 16 20 16 or 19 (149) Database EMBASE lt1980 to 2005 Week 50gt Search Strategy -------------------------------------------------------------------------------- 1 (Portable bladder ultrasound or bladder scan or bardscan or bladderscan)mp [mp=title abstract subject headings heading word drug trade name original title device manufacturer drug manufacturer name] (37) 2 exp Urine Volume (4352) 3 exp Urine Retention (5777) 4 exp BLADDER (28785) 5 exp Bladder Capacity (2007)

6 exp Residual Urine (1200) 7 exp Bladder Emptying (218) 8 exp Bladder Catheterization or exp Urine Incontinence or exp Stress Incontinence or exp Urge Incontinence (15715) 9 or2-8 (50086) 10 exp Ultrasound scanner (422) 11 9 and 10 (15) 12 exp Ultrasound (28612) 13 (mobile or portable or automated or scan or scanner or bedside)mp [mp=title abstract subject headings heading word drug trade name original title device manufacturer drug manufacturer name] (158972) 14 9 and 12 and 13 (64) 15 1 or 11 or 14 (104) 16 limit 15 to (human and english language) (86) 17 exp Systematic Review (7232) 18 Meta Analysis (23734) 19 (systematic review$ or meta-analysis or metaanalysis)mp [mp=title abstract subject headings heading word drug trade name original title device manufacturer drug manufacturer name] (35159) 20 16 and (17 or 18 or 19) (0) 21 16 (86) 22 limit 21 to (editorial or letter or note or review) (4) 23 Case Report (864093) 24 21 not (22 or 23) (73)

Appendix 3

Critical Appraisal Criteria for Diagnostic Studies

Diagnostic Study Critical Appraisal Criteria Reference Relevant Validity Comparison to Gold Standard of Diagnosis Blind Comparison User Training or Protocol Appropriate subjects offered test (Population amp Sampling) Gold standard offered regardless of result Results Sample Size (N) A B C D Sensitivity (aa+c) Specificity (db+d) Positive Predictive Value (aa+b) Negative Predictive Value (dc+d) Positive Likelihood Ratio (sensitivity(1-spec) NLR(1-sensspec) Accuracy (a+D)(a+b+c+d) Pretest Probability (a+ca+b+c+d) Pretest odds (1-prev) Posttest Odds (pretest oddslikelihood ratio) Posttest Probability (posttest odds(postestodds+1) (=PPV) What were the results How Accurate were the results (range CI) Normal range derived Placed in sequence with other diagnostic tests Kappa presented if more than 1 outcome assessor Were likelihood ratios presented or data for their calculation

External Validity Patients similar to my patient Setting similar to my setting is test affordable accurate available Methods of test described to permit replication Prevalence of disease in patients Will results of test affect management if patient (cross a treatment threshold)

Will test results help my patient

References

(1) Ouslander JG Simmons S Tuico E Nigam JG Fingold S Bates-Jensen B et al Use of a portable ultrasound device to measure post-void residual volume among incontinent nursing home residents Journal of the American Geriatrics Society 1994 42(11)1189-1192

(2) Marks LS Dorey FJ macairan ML Park C DeKernion JB Three-Dimensional Ultrasound Device for Rapid Determination of Bladder Volume Adult Urology 1997 50(3)341-8

(3) Bent AE Nahhas DE McLennan MT Portable ultrasound determination of urinary residual volume International Urogynecology Journal 1997 8(4)200-202

(4) Ding YY Sahadevan S Pang WS Choo PW Clinical utility of a portable ultrasound scanner in the measurement of residual urine volume Singapore Medical Journal 1996 37(4)365-368

(5) Huang YH Bih LI Chen SL Tsai SJ Teng CH The accuracy of ultrasonic estimation of bladder volume a comparison of portable and stationary equipment Archives of Physical Medicine amp Rehabilitation 2004 85(1)138-141

(6) Goode PS Locher JL Bryant RL Roth DL BurgioKL Measurement of POstvoid Residual Urine with POrtable Transabdominal Bladder ltrasound Scanner with Urethral Catheterization International Urogynecology Journal 2000 11296-300

(7) Alnaif B Drutz HP The accuracy of portable abdominal ultrasound equipment in measuring postvoid residual volume International Urogynecology Journal 1999 10(4)215-218

(8) Brouwer TA Eindhoven BG Epema AH Henning RH Validation of an ultrasound scanner for determing urinary volumes in surgical patients and volunteers Journal of Clinical Monitoring amp Computing 1999 15(6)379-385

(9) Rosseland LA Stubhaug A Breivik H Detecting postoperative urinary retention with an ultrasound scanner Acta Anaesthesiologica Scandinavica 2002 46(3)279-282

(10) Borrie MJ Campbell K Arcese ZA Bray J Hart P Labate T et al Urinary retention in patients in a geriatric rehabilitation unit prevalence risk factors and validity of bladder scan evaluation Rehabilitation Nursing 2001 26(5)187-191

(11) Revord JP Opitz JL Murtaugh P Harrison J Determining residual urine volumes using a portable ultrasonographic device Archives of Physical Medicine amp Rehabilitation 1993 74(5)457-462

(12) Slappendel R Weber EW Non-invasive measurement of bladder volume as an indication for bladder catheterization after orthopaedic surgery and its effect on urinary tract infections European Journal of Anaesthesiology 1999 16(8)503-506

(13) Moore DA Edwards K Using a portable bladder scan to reduce the incidence of nosocomial urinary tract infections MEDSURG Nursing 1997 6(1)39-43

(14) Teng CH Huang YH Kuo BJ Bih LI Application of portable ultrasound scanners in the measurement of post-void residual urine Journal of Nursing Research JNR 2005 13(3)216-224

(15) Frederickson M Neitzel JJ Hogan Miller E Reuter S Graner T Heller J The Implementation of Bedside

Bladder Ultrasound Technology Effects on Patient and Cost Postoperative Outcomes in Tertiary Care Orthopedic Nursing 2000 19(3)79-87

(16) Abrams P Cardozo L Fall M et al The standardization of terminology of lower urinary tract function report from the standardization Sub=committee of the International Continence Society American Journal of Obstetrics and Gynecology 2002 187(1)116-26

(17) Yagoda Shagam J Urinary Incontinence and Ultrasound Imaging Radiologic Technology 2004 75(4)297-312

(18) Gray M Assessment and Management of Urinary Incontinence The Nurse Practicioner 2005 30(7)35-43

(19) Finkelstein MM Medical conditions medications and urinary incontinence Canadian Family Practicioner 2002 4896-101

(20) Corabian P Bladder Ultrasound Scanning for the Measurement of post-void residual urine volume 1996 Alberta Heritage Foundation for Medical Research

Ref Type Report

(21) Simforoosh N Dadkhah F Hosseini SY Asgari MA Nasseri A Safarinejad MR Accuracy of residual urine measurement in men Comparison between real-time ultrasonography and catheterization Journal of Urology 158 59-61 1997

Ref Type Journal (Full)

(22) Smith NKG Albazzaz MK A prospective study of urinary retention and risk of death after proximal femoral fracture Age Ageing 25 150-4 1996

(23) Diokno AC Diagnostic categories of incontinence and the role of urodynamic testing Journal of the American Geriatrics Society 38 300-5 1990

(24) Smith DA Gauging bladder volume--without a catheter Nursing 1999 29(12)52-53

(25) Resnick B A bladder scan trial in geriatric rehabilitation Rehabilitation Nursing 2003 20(4)194-196

(26) Coombes GM Millard RJ The accuracy of portable ultrasound scanning in the measurement of residual urine volume Journal of Urology 1994 152(6 Pt 1)2083-2085

(27) Chan H Noninvasive bladder volume measurement Journal of Neuroscience Nursing 1993 25(5)309-312

(28) Lewis NA Implementing a Bladder Ultrasound Program Rehabilitation Nursing 20[4] 215-7 1995 Ref Type Journal (Full)

(29) Haley RW Morgan WM Culver DH White JW Emori TG Mosser J et al Update from the SENIC project Hospital infection control recent progress and opportunities under prospective payment American Journal of Infection Control 13[3] 97-108 1985

(30) Anton HA Chambers K Clifton J Tasaka J Clinical utility of a portable ultrasound device in intermittent catheterization Archives of Physical Medicine amp Rehabilitation 1998 79(2)172-175

(31) Jacobsen SJ Girman CJ Roberts RO Rhodes T Guess HA Lieber MM Natural history of prostatism Risk factors for acute urinary retention Journal of Urology 158 481-7 1997

(32) Bodker B Lose G Postoperative urinary retention in gynecologic patients International Urogynecology Journal 2003 14(2)94-97

(33) McCliment JK Non-invasive method overcomes incontinence Program retrains residents to recognize the urge to void Contemporary Long-Term Care 525[5] 2002

(34) Abdel-Fattah M Barrington JW The accuracy of Bardscan a new tool for the measurement of the bladder volume Journal of Obstetrics amp Gynaecology 2005 25(2)186-188

(35) De Ridder D Van Poppel H Baert L Binard J From time dependent intermittent self-catheterisation to volume dependent self-catheterisation in Multiple Sclerosis using the PCI 5000 BladderManagerreg Spinal Cord 35 613-6 1997

(36) Jaeschke R Guyatt GH Sackett DL and the Evidence Based Medicine Working Group How to Use an Article About a Diagnostic Test JAMA 271[5] 389-91 2006

(37) Greenhalgh T How to read a paper Papers that report diagnostic or screening tests BMJ [315] 530-3 1997

(38) Moselhi M Morgan M Use of a portable bladder scanner to reduce the incidence of bladder catheterisation prior to laparoscopy BJOG An International Journal of Obstetrics amp Gynaecology 2001 108(4)423-424

(39) Ireton RC Krieger JN Cardenas DD Williams-Burden B Kelly E Souci T et al Bladder volume determination using a dedicated portable ultrasound scanner Journal of Urology 1990 143(5)909-911

(40) Fakhri S Ahmen MMH Allam SH Akbar M Eyadeh AA Advantages of Using a Portable Ultrasound Bladder Scanner to Measure the Postvoid Residual Urine Volume in Spinal Cord Injury Patients Kuwait Medical Journal 34[4] 286-8 2002

(41) Bland JM Altman DG Statistical Methods for Assessing Agreement Between Two Methods of Clinical measurement Lancet i 307-10 1986

(42) Wooldridge L Ultrasound technology and bladder dysfunction American Journal of Nursing 100[6] S3-11 2000

(43) Canadian Institute for Health Information Ontarios Complex Continuing Care Population Five-Year Trends in Selcted Clinical Characteristic 1999-2000 to 2003-2004 2005

Ref Type Report

(44) Wu J Baguley IJ Urinary retention in a general rehabilitation unit prevalence clinical outcome and the role of screening Archives of Physical Medicine amp Rehabilitation 2005 86(9)1772-7

(45) Tam C Wong K Yip W Incomplete Bladder Emptying in Elderly Wards International Continence Society 2005

Ref Type Electronic Citation

(46) Stark RP Maki DG Bacteriuria in the catheterized patient What quantitative level of bacteriuria is relevant New England Journal of Medicine 1984 311560-4

(47) Frenchman I Cost of Urinary Incontinence in Two Skilled Nursing Facilities A Prospective Study Clinical Geriatrics 2001 9(1)

(48) Canadian Urological Association Urinary Incontinence Guidelines of the Candian Urological Association httpwwwcuaorgguidelinesIncontinence20Guideline_Epdf 2005

(49) American Urological Association AUA Guidelines on the management of benign prostatic hyperplasia Diagnosis and Treatment Reccomendations American Urological Association 1994

(50) Newman DK Palmer MH Incontinence and PPS A New Era OstomyWound Management 199 45(12)32-50

Health Technology Policy Assessment

Completed April 2006

Disclaimer

Executive Summary

Option 2 Recommend portable bladder ultrasound for acute post-surgical care settings Data is not available for catheterized populations in hospital care settings and as such expected outcomes cannot be estimated reliably however hospitals should feel free to explore and evaluate the clinical utility of Portable bladder ultrasound use based on their populations needs

Abbreviations

Issue

Background



Catheters

Intermittent Catheterization

Foley Catheter

X-rays

Ultrasound

Large Stationary Ultrasound

Portable Ultrasound


History



Study Design

Level of Evidence


Summary of Findings of Literature Review

Summary of Existing Health Technology Assessments

Summary of Controlled Diagnostic Experiments Prospective Clinical Series

Post-Operative and Acute Care Patients

Summary of Observational Studies

Medical Advisory Secretariat Review

Economic Analysis


Ontario-Based Economic Analysis

Diffusion

Demographics

Economic Model



Costs

Existing Guidelines for Use of Technology


Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Disclaimer

This health technology scientific literature and policy review was prepared by the Medical Advisory Secretariat Ontario Ministry of Health and Long-Term Care for the Ontario Health Technology Advisory Committee and developed from analysis interpretation and comparison of scientific research andor technology assessments conducted by other organizations It also incorporates when available Ontario data and information provided by experts and applicants to the Medical Advisory Secretariat to inform the analysis While every effort has been made to do so this document may not fully reflect all scientific research available Additionally other relevant scientific findings may have been reported since completion of the review Please contact MASInfomohgovonca if you are aware of scientific research findings that should inform the report or would like further information

The Medical Advisory Secretariat Ministry of Health and Long-Term Care 56 Wellesley Street West 8th floor Toronto ON CANADA M5S 2S3 Email MASinfomohgovonca ISBN

Executive Summary 5

Abbreviations 7

Issue 8

Background 8

History 14

Diffusion 33

Demographics 34

Economic Model 35

Costs 36

Policy Options 41

Appendices 42

Appendix 1 42

Appendix 2 44

Appendix 3 46

References 47

Executive Summary

Abbreviations

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Executive Summary 5

Abbreviations 7

Issue 8

Background 8

History 14

Diffusion 33

Demographics 34

Economic Model 35

Costs 36

Policy Options 41

Appendices 42

Appendix 1 42

Appendix 2 44

Appendix 3 46

References 47

Executive Summary

Abbreviations

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Diffusion 33

Demographics 34

Economic Model 35

Costs 36

Policy Options 41

Appendices 42

Appendix 1 42

Appendix 2 44

Appendix 3 46

References 47

Executive Summary

Abbreviations

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Executive Summary

Abbreviations

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Abbreviations

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Abbreviations

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

History

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

1(g)dagger 0

2(g) 0

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

(ml) Absolute Error

Absolute Error (ml)

Percentage Error ()

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Reference

201 lt50 ml 09 071

201 lt100 ml 095 063

201 gt200 ml 069 069

ge 100 cc 097 091

ge 100 ml 08 087

ge 100 ml 067 097

ge 100 ml 09 081

Neurogenic Bladder

le 200 ml 077 081

Reference

Marks et al 1997(2)

BVI 2500 BVI 2500+

-215 ml (95CI -147 104 ml)

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

72 20 NR 33

2196 159 Plt05

72 Plt05

805 NR 50 22

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Economic Analysis

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

unknown

12 million Ontario

residents

Population

unknown

Acute Care

unknown

200405)

(CCAC)

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Canada Unit Sales

1999 2000 2001 2002 2003 2004 2005

Acute Care 128

Long Term Care 84

Urologists 10

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Policy Options

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Appendices

Appendix 1

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

First First First

Lic Device Class

Issue Date

Device Name

Issue Date

Device Identifier

30416 3 6272001

6272001 0400-0036

6272001 0400-0039 6272001 0570-0090 6272001 0570-0091 6272001 0800-0171

60888 2 1182002

1182002 CHARGER CRADLE 1182002 0570-0155

60889 2 1182002

1182002 0570-0156

61755 3 262003

262003 0570-0154

9172004 0570-0160

63380 3 1292003

1292003 0570-0159

63850 3 2242004

2242004 0570-0161

65809 3 9142004

9142004 0570-0273

68889 2 7212005

7212005 0570-0168

7212005 0570-0175

7212005 0570-0176

7212005 0270-0292

7212005 0270-0300

7212005 0570-0174

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Ref Type Report

Disclaimer

Executive Summary


Abbreviations

Issue

Background



Catheters


Foley Catheter

X-rays

Ultrasound


Portable Ultrasound


History



Study Design

Level of Evidence








Economic Analysis



Diffusion

Demographics

Economic Model



Costs



Policy Options


Appendices

Appendix 1

Appendix 2

Appendix 3

References

Documents

Portable bladder ultrasound · Portable bladder ultrasound products are portable ultrasound devices that use automated technology to digitally register bladder volume, including post-void