Abstract of thesis entitled

“An evidence based guideline of using pelvic floor muscle training in

reducing the severity of urinary incontinence in prostate cancer

patients after having prostatectomy”

Submitted by

LEUNG Lai Ting

For the degree of Master of Nursing

at The University of Hong Kong

in July 2016

Abstract Summary: Despite the improvements in surgical techniques, urinary

incontinence is still a common complication after radical prostatectomy. Urinary

incontinence after operation hampers patient’s sense of wellness and quality of life. It

is also a significant clinical problem to the healthcare system.

Pelvic floor muscles training (PFMT) has been well established in literature for

managing urinary incontinence after prostatectomy. This non-invasive conservative

treatment option is easy to implement and cost-effective. Therefore, there is a strong

reason for implementing it in clinical setting to reduce the severity of urinary

incontinence in men underwent radical prostatectomy.

The objectives of this study are to systemically review the current literature on the

effectiveness of PFMT in prostate cancer patients after having radical prostatectomy.

Data from the selected studies are extracted for establishing table of evidence.

Moreover, quality assessment of the selected articles is performed. An evidence-based

guideline of using pelvic floor muscle training in reducing the severity of urinary

incontinence in prostate cancer patients after having radical prostatectomy is

developed and its feasibility and transferability to the target setting and audience are

determined.

In this study, PFMT program is proposed. The target setting is one of the urology

wards in a local public hospital and the target audience is stage T1 or T2 prostate

cancer patients undergoing radical prostatectomy. Data are extracted from five high

quality studies. It is found that the implementation potential of the proposed guideline

is high because of its transferability, feasibility and cost-effectiveness in the target

setting. An evidence-based practice guideline is therefore developed based on the best

available evidence. With comprehensive plan for implementation and evaluation of

the guideline, it is recommended to establish the practice to the urology ward so as to

reduce the severity of urinary incontinence in post-prostatectomy patients.

An evidence based guideline of using pelvic floor muscle

training in reducing the severity of urinary incontinence in

prostate cancer patients after having prostatectomy

by

LEUNG LAI TING

BSc (Hons) NURS, R.N.

A dissertation submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing

at The University of Hong Kong

July 2016

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Declaration

I declare that this thesis thereof represents my own work, except where due

acknowledgement is made, and that it has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a

degree, diploma or other qualifications.

Signed

Leung Lai Ting

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Acknowledgements

I would like to express my sincere gratitude to my supervisor, Dr. William Li. Without

his valuable guidance and continued assistance throughout this process, this would not

be possible. I had a difficult time for submitting the assignment previously, but with

his understanding and generous support, I could accomplish this dissertation. He

inspired me a lot in completing the dissertation with enrichment of content and

enhancement of my thinking process.

I would also like to take this opportunity to express my heartfelt gratitude to my

beloved husband, Rick Tong. Without his endless support, love and care during these

two years, I would not be able to get to this point. In addition, I offer my heartfelt

blessings to my family, friends, and colleagues for their sincere support, love and

understanding throughout the period of my study.

I also offer my sincere thanks to my groupmates for all their contribution throughout

the dissertation tutorials, which further enriched my learning.

At last, I offer my heartfelt gratitude to my best classmate, Ada Leung. Without her,

my wish of obtaining a Master Degree would not be that memorable, easy and happy.

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Table of Contents

Declaration ...................................................................................................................... i

Acknowledgements ........................................................................................................ ii

Table of Contents ......................................................................................................... iii

List of appendices ........................................................................................................ vii

Chapter 1: Introduction .................................................................................................. 2

1.1 Background ........................................................................................................... 2

1.2 Research Significance........................................................................................... 3

1.3 Affirming needs .................................................................................................... 5

1.4 Research question ................................................................................................. 8

1.5 Objectives ............................................................................................................. 9

Chapter 2: Critical appraisal ........................................................................................ 10

2.1 Searching strategies ............................................................................................ 10

2.2 Inclusion criteria ................................................................................................. 10

2.2.1 Study design ................................................................................................. 10

2.2.2 Subjects ........................................................................................................ 10

2.2.3 Intervention .................................................................................................. 11

2.2.4 Outcome ....................................................................................................... 11

2.3 Exclusion criteria ................................................................................................ 11

2.4 Results ................................................................................................................ 11

2.5 Summary of the studies ...................................................................................... 12

2.5.1 Studies’ characteristics ................................................................................. 12

2.5.2 Subjects’ characteristics ............................................................................... 13

2.5.3 Intervention & control .................................................................................. 13

2.5.4 Assessment points ........................................................................................ 15

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2.5.5 Outcome measure ......................................................................................... 16

2.5.6 Conclusion .................................................................................................... 19

2.6 Critical appraisal strategies ................................................................................. 19

2.6.1 Focused question, randomization & concealment ........................................ 20

2.6.2 Binding & study subjects ............................................................................. 21

2.6.3 Measurements of outcome ........................................................................... 22

2.6.4 Drop-out rate & intention-to-treat ................................................................ 22

2.7 Data synthesis ..................................................................................................... 23

2.7.1 Assessment tools .......................................................................................... 23

2.7.2 Content of PFMT ......................................................................................... 24

2.7.3 Addition of biofeedback to PFMT ............................................................... 24

2.7.4 Control strategies.......................................................................................... 25

2.7.5 Time for initiating PFMT ............................................................................. 26

2.7.6 Timeframe for PFMT ................................................................................... 27

2.7.7 Conclusion .................................................................................................... 27

Chapter 3: Implementation potential ........................................................................... 28

3.1 Target audience/ setting ...................................................................................... 28

3.2 Transferability of the findings ............................................................................ 29

3.2.1 Target audience/ setting ................................................................................ 29

3.2.2 Philosophy of care ........................................................................................ 30

3.2.3 Number of patients benefit from the innovation .......................................... 31

3.3 Time frame .......................................................................................................... 32

3.4 Feasibility ........................................................................................................... 34

3.4.1 Autonomy of nurses to manipulate the innovation....................................... 34

3.4.2 Workload of nurses & administrative and organizational support ............... 34

3.4.3 Facility & education tool .............................................................................. 35

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3.4.3 Interfere to patients ....................................................................................... 36

3.4.4 Potential barriers & strategies to overcome ................................................. 36

3.5 Cost-benefit ratio of the innovation .................................................................... 38

3.5.1 Tangible Cost ................................................................................................ 38

3.5.2 Intangible cost .............................................................................................. 39

3.5.3 Potential risks ............................................................................................... 39

3.5.4 Potential benefit for patients ........................................................................ 40

3.5.5 Potential benefit for nurses ........................................................................... 41

3.5.6 Potential benefit for hospital organization ................................................... 41

3.5.6 Conclusion .................................................................................................... 42

Chapter 4: Developing evidence-based practice guideline .......................................... 43

4.1 Name of evidence-based practice guideline ....................................................... 43

4.2 Objectives ........................................................................................................... 43

4.3 Target audience ................................................................................................... 44

4.4 Intended users ..................................................................................................... 44

4.5 Recommendations .............................................................................................. 45

Assessment ............................................................................................................... 45

Recommendation 1 ................................................................................................ 45

Recommendations 2 .............................................................................................. 45

Intervention ............................................................................................................... 46

Recommendation 3 ................................................................................................ 46

Recommendation 4 ................................................................................................ 47

Evaluation ................................................................................................................. 49

Recommendation 5 ................................................................................................ 49

Chapter 5: Implementation Plan .................................................................................. 50

5.1 Communication plan........................................................................................... 50

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5.1.1. Identification of stakeholders ...................................................................... 50

5.1.2. Communication plan with administrators ................................................... 52

5.1.3 Communication with urology physicians ..................................................... 54

5.1.4 Set up of steering committee ........................................................................ 54

5.1.5 Communication with frontline nurses .......................................................... 55

5.1.6 Monitoring and sustaining the change ......................................................... 56

Chapter 6: Pilot testing plan ......................................................................................... 57

6.1 Objectives of the pilot test .................................................................................. 57

6.2 Study design ....................................................................................................... 57

6.3 Data collection and analysis ............................................................................... 58

Chapter 7: Evaluation plan........................................................................................... 60

7.1 Identifying outcomes to be achieved .................................................................. 60

7.1.1 Outcome for effectiveness evaluation .......................................................... 60

7.1.2 Outcomes for qualitative/ process evaluation .............................................. 61

7.1.3 Outcome for cost/ risk evaluation ................................................................ 62

7.2 Data collection .................................................................................................... 62

7.3 Data analysis ....................................................................................................... 64

7.4 Nature and number of patients involved ............................................................. 65

7.5 Basis for implementation of protocol ................................................................. 65

7.5.1 Reduction on the number of incontinence episodes ..................................... 66

7.5.2 Satisfaction of patients and healthcare providers ......................................... 66

7.5.3 Cost and utilization....................................................................................... 67

Chapter 8: Conclusion.................................................................................................. 68

References .................................................................................................................... 70

Appendices ................................................................................................................... 74

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List of appendices

Appendix 1 - PRISMA flow diagram ....................................................................... 74

Appendix 2 - Table of Evidence (1): ........................................................................ 75

Appendix 3 - Table of Evidence (2): ........................................................................ 76

Appendix 4 - Table of Evidence (3): ........................................................................ 77

Appendix 5 - Table of Evidence (4): ........................................................................ 78

Appendix 6 - Table of Evidence (5): ........................................................................ 79

Appendix 7 - SIGN Checklist for RCT Studies (1) (Goode et al., 2011) ................. 80

Appendix 8 - SIGN Checklist for RCT Studies (2) (Tienforti et al., 2012) ............. 81

Appendix 9 - SIGN Checklist for RCT Studies (3) (Centemero et al., 2010) .......... 82

Appendix 10 - SIGN Checklist for RCT Studies (4) (Filocamo et al., 2010) .......... 83

Appendix 11 - SIGN Checklist for RCT Studies (5) (Burgio et al., 2006) .............. 84

Appendix 12 – Cost & benefit table ......................................................................... 85

Appendix 13 - SIGN grading system ....................................................................... 86

Appendix 14 – Timeframe for communication & evaluation plan ........................... 87

Appendix 15 - Satisfactory survey of patients.......................................................... 88

Appendix 16 – Satisfactory survey of nurses ........................................................... 89

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Chapter 1: Introduction

1.1 Background

Prostate cancer is the third most common cancer among men in Hong Kong and it is

on a rising trend (Hospital Authority, 2012). However, it is a mercy that as carcinoma

of prostate usually grows slower than other types of cancers, the 10-year survival

probability for localized prostate cancer patients was around 90% with current

curative treatments (To & Yiu, 2011).

In current practice, there are several curative treatment methods for men with

localized carcinoma of prostate, depending on the stage of disease. Regular active

surveillance could be adopted for men with in early stage. Other treatment approaches

include surgery, radiation, chemotherapy and hormonal therapy. Among these

treatment options, radical prostatectomy is the gold-standard for men with prostate

cancer in Hong Kong (Chan et al., 2008).

Although prostatectomy is potentially curative, various post-operative complications,

include bleeding, infection, sphincter injury, erectile dysfunction and urinary

incontinence, may occur. Among them, urinary incontinence is one of the most

disturbing complications that can be occurred soon after catheter removal after

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surgery (Fu, Moul & Sun, 2011). Urinary incontinence defined as an involuntary loss

of urine, the degrees of severity can be ranging from dribble urine to total leakage.

Stress incontinence, i.e. leakage of urine during coughing, laughing or sneezing, is the

commonest type of incontinence. Two to 43% of men who undergone prostatectomy

encountered impaired urethral closure, leading to stress incontinence (Trost & Elliott,

2012).

1.2 Research Significance

Studies reported that almost all men experienced urinary incontinence for the first 3-6

months after prostatectomy (MacDonald, Fink, Huckabay, Monga & Wilt, 2007).

Similarly, from the internal data in a public hospital in Hong Kong, it is observed that

more than 90% of men experienced urinary incontinence after prostatectomy.

Normal urination occurs when the muscles of bladder wall contract and the muscles

along the urethra relax. With current advanced technology in removing prostate, there

are still some degrees of muscles or nerves damage that disrupt the normal urination

mechanism. Urinary control becomes difficult as the strength of pelvis endofascia and

external sphincter muscles are disrupted (Hunter, Glazener & Moore, 2007).

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Although this urinary problem can be transient, it can also be persistent, i.e. continue

for more than 1 year (Goode et al., 2011). Urinary incontinence can undoubtedly

cause severe emotional burden to patients. It is not uncommon for them to feel

distressing, helpless, and shameful about the urinary loss (Serdà & Marcos-Gragera,

2014). Such negative emotional effects may cause them to be isolated from their

normal occupational and social activities, to prevent humiliation resulted from urine

odors and wet pants. This imposed severe negative impact on their quality of life.

Studies showed that urinary incontinence is considered the most bothersome and

distressing post-operative complication to prostate cancer survivors, and the impact of

incontinence is more significant in men than in women (Higa, Lopes & D'Ancona,

2013). In some cases, psychological problems like depression, insomnia, and anxiety

may developed, which may further complicated the treatment progress. Furthermore,

the continuous use of incontinence pads or insertion of indwelling catheters do not

only causes financial burdens to patients and the healthcare system, it also causes the

patients to be suffered from the associated physical complications, i.e. urinary tract

infection, contact dermatitis (Kakihara, Sens & Ferreira, 2007).

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The overall effects of post-prostatectomy urinary incontinence are the reduction of

patient’s quality of life, in terms of physical, sociocultural and psychological aspects;

hinder normal treatment and healing process; and dramatically increase the cost of

care. Therefore, innovation for reducing the severity of post-prostatectomy urinary

incontinence is urgently needed.

With the mission of providing holistic care to patients, nurses play an important role

to take care of the incontinence problem by developing and evaluating evidence-based

intervention to reduce the severity of urinary incontinence. The development of an

effective evidence-based protocol not only can improve the patients’ outcomes

following radical prostatectomy, but also can empower them to regain their health and

stay healthy physically and mentally.

1.3 Affirming needs

The inconvenience and distress caused by post-prostatectomy urinary incontinence

significantly hamper patient’s sense of wellness and quality of life. It also increases

their risk of other physical and psychological complications caused by the unpleasant

nature of incontinence during recovery.

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To many patients, they believe that urinary incontinence is an inevitable consequence

of prostate cancer. This belief commonly associated with anxiety and the feeling of

inability to control over the bodily function, which prevents them from seeking

medical assistance or sharing what they suffer to others (Higa, Lopes & D'Ancona,

2013).

Indeed, some studies showed that post-operative urinary incontinence can be

reversible with early pelvic floor muscle training (PFMT), which can hasten the

regain of continence in a long run (Filocamo, Marzi, Popolo, Cecconi, Marzocco, Tosto &

Nicita, 2005; Goode et al., 2011; ). The rationales behind is that PFMT trains up the

damaged urethral sphincter and detrusor muscle by strengthening and increasing the

endurance of the pelvic floor muscles (Filocamo et al., 2005). Urinary control can be

greatly improved if the pelvic floor muscles are strengthened. Patients also can take

self-initiation to perform pelvic floor muscle exercise after supervised trainings, this

allows the patients to have increased sense of control over the body, and actively

engaged to the treatment regime. As the severity of urinary incontinence is improved,

patients will also have less emotional, social and physical burdens. Consequently, the

quality of life will be improved.

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Despite PFMT has been advocated as an effective non-invasive method for achieving

urinary continence in current studies, evidence-based non-invasive treatments for

post-prostatectomy patients are lacking in current clinical settings. In the target setting,

i.e. one of the urology ward in a local public hospital, post-operative education to

prostate cancer patients mainly focus on lifestyle modifications. Patients are advised

to reduce alcohol and caffeine intake, avoid excessive fluid intake, reduce body

weight, relieve constipation and perform exercise regularly during post-operative

consultation sessions. The variety of continence products are also introduced to

patients for their selection. If incontinence persisted for more than a year, urinary

catheters, male slings and artificial urinary sphincter (AUS) will be the main

treatment options (Hong Kong Continence Society, 2013).

There are gaps between the current practice and proposed new intervention. Studies

showed that there was an overall benefit from PFMT versus control management, i.e.

lifestyle modification, in reducing the urinary incontinence in prostatectomy patients

(MacDonald, Fink, Huckabay, Monga & Wilt, 2007; Tienforti et al., 2012). They

added that post-prostatectomy incontinence should be treated initially by PFMT, but

not lifestyle modifications alone. Also, although the indwelling catheter and male

slings are less invasive options, they both commonly cause pain, blockage and

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infection that require removal. Whereas, AUS, a more invasive surgical option, may

predispose patient to other complications like urethral atrophy, infection and

mechanical failure that required revisions or re-implantation (Hong Kong Continence

Society, 2013).

Nevertheless, it is showed that pelvic floor exercise training is a side-effects-free,

natural and cost-effective way to hasten the regain of continence and improve the

quality of life for patients (Nilssen, Morkved, Overgard, Lydersen & Angelsen, 2012).

Therefore, it is important to perform further clinical trials for developing a

comprehensive protocols and guidelines in activating PFMT for all patients

undergone radical prostatectomy, as it may hasten the regain of continence, reduce

their suffering and emotional burden, minimizing financial expenditure for both

patient and health care system.

1.4 Research question

After discussion the background of current problem and the need for developing a

new evidence-based practice, the research question “Is pelvis floor muscle training

effective in reducing the severity of urinary incontinence in prostate cancer patients

after having radical prostatectomy?” is developed.

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1.5 Objectives

The objectives of the dissertation are:

1. To review current literature and identify evidence of using pelvic floor muscle

training in the reducing the severity of urinary incontinence for prostate cancer

patients undergoing radical prostatectomy.

2. To perform critical appraisal and synthesize recommendations for the use of

pelvic floor muscle prostate cancer patients undergoing radical prostatectomy

based on the literatures selected.

3. To formulate recommendations and establish an evidence-based protocol to

reduce the severity and duration of urinary incontinence in patients undergoing

prostatectomy.

4. To assess the implementation potential of the protocol in prostate cancer

patients in public hospitals in Hong Kong.

5. To formulate a plan for implementation and to evaluate the protocol.

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Chapter 2: Critical appraisal

2.1 Searching strategies

The relevant literature search was conducted through the following electronic

database: PubMed, ScienceDirect, CLINAHL, Cochrance Library, and Medline from

November to December, 2015. The searching history PRISMA flowchart was shown

in Appendices 1. Search keywords radical prostatectomy, urinary incontinence or

continence, pelvic floor muscle exercise or pelvic floor muscle training or Kegal

exercises were used. Publication language was limited to English.

2.2 Inclusion criteria

2.2.1 Study design

Studies design was restricted to randomized controlled trials evaluating the

effectiveness of pelvic floor muscle training on urinary incontinence after radical

prostatectomy.

2.2.2 Subjects

Patients with prostate cancer who underwent open radical prostatectomy, laparoscopic

radical prostatectomy, or robot-assisted laparoscopic radical prostatectomy were

included.

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2.2.3 Intervention

Pelvic floor muscle training with or without biofeedback was included in the search.

The duration and frequency of the training were not limited.

2.2.4 Outcome

Primary outcome was the reduction of severity in urinary incontinence, i) percentage

or number of reduction in incontinence episodes, ii) shortened duration to continence.

Secondary outcome was the quality of life.

2.3 Exclusion criteria

Literature with only abstracts, published more than 10 years ago, or with insufficient

information were excluded.

2.4 Results

Five databases, including PubMed, ScienceDirect, CLINAHL, Cochrance Library,

and Medline were consulted. 364 journals evaluated. An addition of 2 journals were

also identified through the reference list suggested in the journals. The search was

further refined based on the search keywords and all duplicated papers were excluded,

48 potential journals were then screened based on the abstracts, and 30 journals were

excluded as the inclusion and exclusion criteria were not met. 18 journals were further

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assessed with the full-text. After analyzed against the set criteria that have been

discussed previously, five relevant journals were identified for throughout quality

assessment (Goode, Burgio, Johnson, Clay, Roth, Markland, Burkhardt, Issa & Lloyd,

2011; Tienforti, Sacco, Marangi, D'Addessi, Racioppi, Gulino & Bassi, 2012;

Centemero, Rigatti, Giraudo, Lazzeri, Lughezzani, Zugna, Montorsi & Rigatti, 2010;

Filocamo, Marzi, Popolo, Cecconi, Marzocco, Tosto & Nicita, 2005; Burgio, Goode,

Urban, Umlauf, Kicher, Bueschen & Redden, 2006).

A summary of the five journals was shown in the Tables of Evidence in Appendixes

2-6. Scotthish Intercollegiate Guidelines Network (SIGN) checklist was used to assess

for the quality of the five selected randomized control trial journals (Appendixes

7-11).

2.5 Summary of the studies

2.5.1 Studies’ characteristics

A total five sources published in last ten years were selected, they are all

concentrating on the use of pelvic floor muscle training for hasten the recovery of

continence post-prostatectomy (Goode et al., 2011; Tienforti et al., 2012; Centemero

et al., 2010; Filocamo et al., 2005; Burgio et al.2006). All of them are randomized

controlled trials, conducted in United States or Italy. Of the five studies, four

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consisted of relatively large sample sizes, ranged 125 to 300, while there was only 38

samples in Tienforti et al.’s (2012) study.

2.5.2 Subjects’ characteristics

Participants recruited in the studies were all diagnosed with prostate cancer without

metastasis, who underwent elected radical prostatectomy or radical retropubic

prostatectomy. Two studies highlighted that only localized prostate cancer with

cT1a-cT2b will be recruited (Tienforti et al., 2012; Centemero et al., 2010). Another

study included participants at their prostate cancer stage T1 or T2 (Filocamo et al.,

2005).

All studies’ participants were medically stable, mentally stable, urinary continent and

ambulatory prior radical prostatectomy. Within the five studies, participants’ age

ranged from 45-84 years old.

2.5.3 Intervention & control

All of the studies introduced pelvic floor muscle training (PFMT) to manage

post-prostatectomy incontinence. However, the precise details on the pelvic floor

muscle program varies. The amount and frequency of PFMT supervision were

different.

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Two studies evaluate the use of PFMT with biofeedback, i.e. electrical stimulation,

compared to no pelvic floor muscle instruction/ written instructions (Tienforti et al.,

2012; Burgio et al.2006). One study compared PFMT alone to no pelvic floor muscle

instruction (Filocamo et al., 2005). One study compared PFMT with or without

biofeedback to delayed treatment at 8 weeks post-operatively (Goode et al., 2011).

Another study compared PFMT educated pre- and post-operatively compared to

post-operative education only (Centemero et al., 2010). Biofeedback is performed by

placing a small anal probe into anal canal and electrodes on abdomen, electrical

signals collected during pelvic floor muscle contraction will be shown in the computer,

which thought to give participants more precise contraction.

Tienforti et al. (2012) provided a supervised 20 minutes PFMT the day before

operation and reinforced monthly until 6 months. Similarly, Burgio et al. (2006) also

provided a single PFMT the day before operation, but there was no session after

operation. Goode et al. (2011) implemented 4 sessions of PFMT, two weeks apart.

Filocamo et al. (2005) started PFMT immediately after urinary catheter removed after

operation with total 3 session conducted weekly. Centemero et al. (2010) started 30

minutes PFMT 30 days before operation, continued twice per week until post-op 3

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months. Although three of the studies did not mention the duration of PFMT in each

training, the content of all the PFMT was almost the same.

All PFMT session included the explanation of urinary system related anatomy,

breathing coordination, education on how to control dominant pelvic floor muscle and

how to palpate the contracted muscle. Almost all participants in treatment group were

instructed to perform home pelvic floor muscle exercises, 3 times daily with 10-15

repetitions of two to ten seconds contraction and relaxation alternatively based on

participants’ ability. Only the study of Centemero et al. (2010) did not include home

exercise, this may explain why the PFMT was more intense, i.e. 8 sessions in total.

2.5.4 Assessment points

The length of follow up and outcome measurement point were different in the studies.

Goode et al. (2011) had the shortest post-operative measurement point, i.e. 2-months.

Followed by Centemero et al.’s (2010) measurements at 1- and 3-months following

radical prostatectomy. Tienforti et al. (2012) and Burgio et al. (2006) measured till

half year post-operatively, i.e. at 1-, 3-, 6- months. Filocamo et al. (2005) measured

the outcome until one year post-op, i.e. at 1-, 3-, 6-, 12-months.

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2.5.5 Outcome measure

The studies mainly measured the number of participants returning to urinary

continence or the severity of incontinence episodes as primary outcome. Quality of

life was also measured in some of the studies as secondary outcome. The scales used

in measurement were not all common in the five studies.

2.5.5.1 Severity of incontinence (primary outcome)

Five of the studies showed that the severity of incontinence after radical

prostatectomy reduced with the use of PFMT, the incontinence episodes and the

duration of continence were both significantly reduced. The reduction in the

severity of urinary incontinence is also of clinical effective and acceptable level in

target setting.

(i) Incontinence episodes

Goode et al. (2011) and Tienforti et al. (2012) both used 7 day bladder diary to

record incontinence episodes per week. They both found that PFMT significantly

reduce the severity of incontinence. In Goode et al.’s (2011) study, there was 8

episodes reduction per week in PFMT without biofeedback and 12 episodes

reduction in PFMT with biofeedback when compared to the group with no PFMT

at 2-month follow-up. Yet, it was found to have no significant difference in the

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number of incontinence episodes between the two active groups, i.e. PFMT with

and without biofeedback. This result highlighted that biofeedback is not clinical

effective to improve incontinence post-prostatectomy in addition to PFMT. In

Tienforti et al.’s (2012) study, there was around 10 episodes reduction per week in

PFMT group compared to no PFMT group in 3- and 6-months follow-ups.

(ii) Duration of incontinence

Three studies showed that the duration of incontinence reduced with PFMT, more

participants regain continence earlier than in control.

Centemero et al. (2010) and Burgio et al. (2006) both reported the recovery of

continence by bladder diary but did not mention the number of reduction in

incontinence episodes. It is shown that around 20% more participants regained

continence in PMFT group than in control at 1- and 3-months follow-ups

(Centemero et al., 2010). A 6-months study showed that participants’ duration of

incontinence was reduced by 3 months after PMFT when compared to no PFMT

(Burgio et al., 2006).

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Filocamo et al. (2005) also showed that PFMT was beneficial to patients for early

regaining of continence based on pad test, the benefit was significant at 3- and 6-

months follow-ups (approximately 40% more participants in PFMT group

regained continence), but the difference was not significant at 12-months.

2.5.5.2 Quality of life (secondary outcome)

Three studies supported that quality of life will be improved after PFMT in

post-prostatectomy men.

Goode et al. (2011) stated that the quality of life in PFMT group had significantly

improved than that in control, patients felt less burden as measured by Expanded

Prostate Cancer Index Compostie (EPCI) scale. Tienforti et al. (2012) also

reported better quality of life in PMFT group with IPSS-QoL scale. Centemero et

al. (2010) stated that ICS male SF score was higher in PFMT group, indicating

better quality of life.

One study showed no group difference in the quality of life with PFMT, measured

by Medical Outcomes Study Short Form Health Survey (Burgio et al., 2006).

Filocamo et al. (2005) did not measure quality of life in the study.

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2.5.6 Conclusion

All studies identified concluded that pelvic floor muscle training was effective in

reducing the severity of urinary incontinence after prostatectomy. Two studies showed

significant reduction of incontinence episodes at 2-months follow-up (Goode et al.,

2011) and up to 6-months follow up (Tienforti et al., 2012). Three studies reported a

shorter duration of incontinence in treatment group up to 6-months follow-up

(Centemero et al., 2010; Burgio et al., 2006; Filocamo et al., 2005). PFMT should be

introduced to prostate cancer patients as early as possible after prostatectomy because

the effect is not significant after 6-month (Filocamo et al., 2005). Pelvic floor muscle

exercise with biofeedback did not provide greater effectiveness to hasten the rate of

continence (Goode et al., 2011). In addition, three studies highlighted that quality of

life of prostate cancer patients would be improved with the help of PFMT (Goode et

al., 2011; Tienforti et al., 2012; Centemero et al., 2010).

2.6 Critical appraisal strategies

Internal validity of all studies were checked using SIGN methodology checklist. All

studies selected were randomized controlled trials (Goode et al., 2011; Tienforti et al.,

2012; Centemero et al., 2010; Filocamo et al., 2005; Burgio et al.2006). The details

for the SIGN checklist of each study were attached in Appendix 7-11.

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After reviewing the studies using SIGN checklist, three studies were of high quality

(Goode et al., 2011; Centemero et al., 2010;Burgio et al.2006), one was of acceptable

quality (Tienforti et al., 2012), and the rest of low quality (Filocamo et al., 2005).

2.6.1 Focused question, randomization & concealment

The topics and research question were well defined and specified in all five studies.

Good randomization were applied and well reported in four studies and therefore

increase the validity of the studies (Goode et al., 2011; Tienforti et al., 2012;

Centemero et al., 2010; Burgio et al.2006). Detailed methods of randomization

procedure, i.e. computer generation, allocation sequence, were clearly elaborated.

Thus, the allocation bias or the confounding effect in these studies were minimized.

The quality of one study was down-graded because the randomization was mentioned

without any details (Filocamo et al., 2005).

Three studies provided good quality of concealment method in randomization

allocation (Goode et al., 2011; Centemero et al., 2010; Burgio et al.2006). Sequential

numbered, sealed and opaque envelopes were used in two studies and centralized

allocation was used in another study. Two of the five studies were downgraded

because concealment was mentioned without details (Tienforti et al., 2012), or even

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worse, no concealment was mentioned (Filocamo et al., 2005). This may adversely

affect the validity of the results.

2.6.2 Binding & study subjects

To minimize the study bias, four study designs contained some blinding to surgeon,

investigators and nurses about the group assignment (Goode et al., 2011; Tienforti et

al., 2012; Burgio et al., 2006), except Filocamo et al. (2005) did not reported the

blinding about the treatment allocation. Yet, bias is not an apparent concern in the

studies selected.

The baseline demographic and characteristics of patients were similar between

treatment and control groups in four studies (Goode et al., 2011; Tienforti et al., 2012;

Filocamo et al., 2005; Burgio et al.2006). Age, baseline urologic results, PSA level,

cancer stage, mental status and body weight were adequately compared between

groups, so that the comparison between groups could be more precise. There was

mean age statistically significant difference between active group and control group in

a study (Centemero et al., 2010). The participants in active group were younger than

those in control group, it could be possible that the improvement in continence was

due to the higher motivation of younger men to perform PFMT.

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2.6.3 Measurements of outcome

All measurements of outcome were clearly stated and relevant in all the five studies.

Continence status (primary outcome), was measured by bladder dairies, or more

subjectively by pad test. Bladder dairies were commonly used for patients to record

the continence status, i.e. incontinence episodes, however, the reliability is relatively

low and is highly depends on patients’ self-compliance on the usage of dairies.

However, it is justified and valid to use this method to assess the continence status.

For the secondary outcome, although the measurement scale was not standardized,

quality of life was measured by different reliable measurement scales. ICS male SF

score was used to assess for the change in quality of life (Centemero et al., 2010). The

rest of studies used Expanded Prostate Cancer Index Compostie (EPCI) scale (Goode

et al., 2011) and IPSS-QoL scale (Tienforti et al., 2012) to measure patients’ quality of

life after PFMT. All the outcome measurement method employed by the studies were

valid and reliable.

2.6.4 Drop-out rate & intention-to-treat

The duration of study was generally 6 or 12 months, except Centemero et al. (2010)

had 3 month study. There was no participant lost to follow-up in Centemero et al.’s

study. The drop-out rate was high in another study (Goode et al., 2006). 22.9% in

PFMT with biofeedback, 17.1% in PFMT without biofeedback and 5.9% in control

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group. The higher drop-out rate in treatment groups were justified, considered that the

control group only follow-up and assessed until 2-month, while the other two

treatment groups had follow-up until 12-months. Also, the reasons for why

participants dropped out were explained with reasonable details, therefore, the study

was not downgraded. Among the rest of the studies, drop-out rate ranged from 1.3%

to 11.2%, which is conventionally regarded as acceptable.

Intention-to-treat analysis was used in three studies (Goode et al., 2011; Centemero et

al., 2010; Burgio et al., 2006). Participants who lost to follow-up were all included in

the analysis, hence, bias due to missing value was minimized.

2.7 Data synthesis

2.7.1 Assessment tools

Due to the nature of this intervention, participants must be capable to remember the

instructions on pelvic floor muscle training and practice regularly, therefore, the

mental status must be assessed prior to recruiting patients for PFMT. Mini-Mental

State examination (MMSE) was commonly used in all selected literature as a tool to

assess normal mental status.

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Other assessments that were important to measure the study outcome included bladder

diary, pad test and quality of life assessment scales, i.e. Expanded Prostate Cancer

Index Compostie (EPCI) scale, ICS male SF score and IPSS-QoL scale. No single

outcome assessment tool was commonly used among all the five studies. Assessment

tools were not a factor that affect the effectiveness of the intervention, therefore,

suitable assessment tools could be selected based on departments’ clinical practice.

2.7.2 Content of PFMT

PFMT program included education of basic urinary anatomy, breathing coordination,

repetitive contract and relax pelvic floor muscles voluntarily and home pelvic floor

muscle exercises. Besides the face-to-face training from health care professionals,

written instruction was thought to be important for participants for better

understandings and to continue pelvic floor muscle training at home (Tienforti et al.,

2012).

2.7.3 Addition of biofeedback to PFMT

Although the content in the PFMT was similar among the five studies, the use of

biofeedback in addition to PFMT varies. Goode et al. (2011) showed that biofeedback

did not improve the effectiveness of PFMT program, there was no significant

difference among the two treatment groups. Burgio et al. (2005) also stated that they

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did know the effect of biofeedback on the study outcome and added that PFMT would

have been effective even without biofeedback. Therefore, biofeedback is not

necessary to be included in this evidence-based protocol for reducing the severity of

urinary incontinence. Indeed, the use of subcostal digital assessment could also serve

the same purpose to evaluate correct contraction and relaxation of pelvic floor

muscles (Centemero et al., 2010; Filocamo et al., 2005)

2.7.4 Control strategies

PFMT training were proved to be effective in reducing the severity of urinary

incontinence in post-prostatectomy patients. Four studies included home pelvic floor

muscle exercises education in their PFMT (Goode et al., 2011; Tienforti et al., 2012;

Filocamo et al., 2005; Burgio et al.2006). The compliance of PFMT at home was

thought to be an important element that may affect the efficacy of the treatment.

Goode et al. (2011) maintained 80% of participants for continued adherence to

exercise strategies throughout the study. It was suggested that the high compliance

rate could be maintained by caregivers’ postoperative guidance, interaction with

health-care professional, regular clinical visits and recording bladder dairy (Goode et

al., 2011; Tienforti et al., 2012, Filocamo et al. 2005).

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2.7.5 Time for initiating PFMT

Tienforti et al. (2012) and Burgio et al. (2006) both provided PFMT the day before

operation. Goode et al. (2011) & Filocamo et al. (2005) started PFMT immediately

after urinary catheter removed after operation. Centemero et al. (2010) started PFMT

30 days before operation. However, both pre-operative and post-operative PFMT was

proven to be effective in reducing the severity of urinary incontinence

post-prostatectomy. The time for initiating PFMT could be set depends on the

smoothness on clinical operation, but it should not be later than urinary catheter

removal after surgery.

The pelvic floor muscle training seems to be most effective in the first two months

onwards and up to six months after surgery. The effective of PFMT decrease after 6

months. Filocamo et al. (2005) showed at 12-month, there was no clinical and

statistically difference between treatment and control group in reducing the severity of

urinary incontinence. Therefore, PFMT should be initiate as early as possible after

prostatectomy, so that patients could strengthen the pelvic floor muscle to increase

control over voiding before it is too late.

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2.7.6 Timeframe for PFMT

The number of PFMT sessions provided to participants varies among the studies.

Burgio et al. (2006) proved that single session of PFMT was already effective in

reducing the severity of urinary incontinence, while Centemero et al. (2010) provided

a total of 8 sessions of supervised PFMT. Indeed, there was no standard number of

PFMT session that was proven to be most effective in current literature review. It is

believed that the number of PFMT session could be adjusted by healthcare

professional based on patients’ ability to understand and perform proper pelvic floor

muscle exercises.

2.7.7 Conclusion

Urinary incontinence after radical prostatectomy is particularly upsetting for men and

may seriously worsen the quality of life of these patients who survived from prostate

cancer. However, literature strongly support the use of pelvic floor muscle training in

these patients. Pelvic floor muscle training was shown to be effective in reducing the

severity of urinary incontinence for patients after prostatectomy as discussed

previously. Some studies also showed that the quality of life of participants may also

improve after PFMT. A comprehensive evidence-based protocol for using PFMT in

reducing the severity of urinary incontinence is urgently need, so that more men could

be benefit from it.

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Chapter 3: Implementation potential

The implementation of pelvic floor muscle training (PFMT) in reducing the severity

of urinary incontinence is supported by literature findings. In this chapter, the

implementation potential will be assessed thoroughly before this proposed

evidence-based protocol is introduced into the clinical setting. The target audience,

target setting, transferability, feasibility, cost and benefit of PFMT protocol will be

discussed in details, so as to ensure the innovation is appropriate to the target clinical

setting.

3.1 Target audience/ setting

Target audience

The target audience included will be male patients who are diagnosed with localized

prostate cancer (stage T1 or T2) and are admitted to targeted urology ward for elective

radical prostatectomy. There is no limitation on age but patients must be mentally fit,

able to follow instructions, ambulatory and urinary continence before operation. The

age-specific incidence rate of prostate cancer in Hong Kong occurred in 45 year-old

and peak at 75 year-old (Hong Kong Cancer Registry, 2009).

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Target setting

The innovation will be implemented in a urology ward at Department of Surgery in a

local public hospital under Kowloon West Cluster in Hong Kong. The ward consists

of 44 beds for male patients. Patients with prostate cancer who proceed to elective

radical prostatectomy would normally admit one day before operation for

pre-operative workup and the median length of stay post-operatively would be around

4 to 5.5 days. All patients would have ward follow-ups monthly after discharged for

six months, and then referred to Specialist Out-patient Department (SOPD) for

continue monitoring of disease. The prevalence of such case is around 30 patients

per year. The proposed innovation will be executed by nurses. Currently, there are

sixteen registered nurses and three advanced practice nurses who work in the ward.

3.2 Transferability of the findings

3.2.1 Target audience/ setting

All participants recruited in the reviewed studies were diagnosed with stage T1 or T2

prostate cancer patients and underwent elective radical prostatectomy, except the

studies of Goode et al. (2011) had not mentioned the stage of prostate cancer. All

participants recruited in the studies were mentally fit, able to perform PFMT,

ambulatory and continence before operation. The age of participants in the reviewed

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studies ranged from 45 to 84 years-old, which were also comparable with that of the

targeted audiences described in the previous section.

For the innovation of PFMT, due to the common anatomy shared by humans, the

mechanism to train up urethral sphincter and strengthen detrusor muscle to hasten

recovery of urinary control would not be altered by different race and ethnicity.

Therefore, the reviewed studies conducted in Italy, United Stated and America could

be transferable to Hong Kong setting.

3.2.2 Philosophy of care

The core values shared by all nursing staff in Hospital Authority is to provide

professional people-centered care with the best possible services, and with caring

heart to meet patients’ needs (Hospital Authority 2016). Radical prostatectomy serves

to save the life of patients with prostate cancer, yet, this is not the only job appreciated

by Hospital Authority. The philosophy of nursing is to care our patients holistically,

not only limited to physical health, but also emotional well-being. As discussed in

Chapter 1, the complication of radical prostatectomy, i.e. urinary incontinence, has

undoubtedly caused heavy emotional burden to prostate cancer survivors. The mercy

is that the best available evidences have shown that PFMT is effective in reducing the

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severity of this complication, which may promote well-beings and lead to better

quality of life. In view of this, nurses take an essential role and responsibility to

source out the best possible innovation and implement the evidence based protocol to

clinical setting if possible. Although all reviewed studies were conducted in Western

country, the philosophy of care to provide holistic quality care to patients shared in

Hong Kong. Hence, the philosophy of care underlying the proposed innovation was

consistent fundamentally with the philosophy prevailing in the targeted setting.

3.2.3 Number of patients benefit from the innovation

The proposed protocol is beneficial to all male patients who underwent elective

radical prostatectomy. According to the internal statistics in the Surgical Outcomes

Monitoring and Improvement Program (SOMIP) database in 2014, there were around

278 cases of radical prostatectomy performed every year. In the preliminary proposed

target setting, there are around 30 cases per year (Hospital Authority, 2016). Among

them, based on clinical observation, 92% of them were complicated with

post-prostatectomy urinary incontinence. With this manageable number of patients in

the target setting, it is believed that the innovation could cover all of the male patients

who underwent radical prostatectomy and benefit all of them in a long run.

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3.3 Time frame

A Prostate Cancer Continence Steering Committee will be set. The members of

committee include one advanced practice nurse and three registered nurses who have

completed the Post-registration Certificate Course (PRCC) in Urology. The consensus

for the recommendations of the protocol will be obtained. The committee is also

responsible of assessing and evaluating the outcomes of the innovation in the targeted

setting and periodically update the protocol based on best available evidences.

For the smooth operation of the proposed protocol in the targeted setting, sufficient

consultation period could be held. The goal, cost and benefit and the details of the

innovation should be clearly discussed with all relevant parties, including urologists,

General Nursing Manager (GMN), ward manager, advanced practice nurses and

registered nurses in the urology ward. Three months will be deemed sufficient for all

parties to voice out concerns and provide constructive suggestions for the smooth run

of the protocol.

The consultation period will be then followed by a two-month preparation period.

During this period, administrative parties will be responsible for seeking funding from

department; preparing printing materials regarding PFMT; ensuring facility in ward

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follow-up consultation room is sufficient for the innovation. The frontline staff,

including advanced practice nurses and registered nurses, are well trained with PFMT

conducted by physiotherapists during office hours to ensure all staff are willing to

acquire new skills and are comfortable to supervise targeted audience.

For incremental approach of change, pilot run will be conducted for three months.

Feedbacks and comments are welcomed and opened to all relevant parties for

improvement. The data and outcome measures collected will be analyzed, the

smoothness of the operation of innovation will also be evaluated. All relevant parties

will be invited to meetings to make changes to the protocol, if any, in order to

optimize the smooth run of innovation.

After the pilot run, phased implementation will be conducted with the optimized

protocol. The proposed protocol will be implemented in the targeted setting for

another 9 months and the outcome will be evaluated. If the outcome is clinically

positive, the proposed protocol will be then implemented in the ward as usual practice

in long run.

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3.4 Feasibility

To assess the feasibility of adopting the proposed protocol in the targeted setting,

autonomy of nurses, workload of nurses, administrative and organizational support,

and availability of facility were thought to be important factors for executing optimal

patient care (Currie, Harvey, West, McKenna & Keeney, 2005).

3.4.1 Autonomy of nurses to manipulate the innovation

Autonomy of nurses to control over the innovation has been identified to be a

significant factor affecting the productivity for optimal patient care (Scott, Sochalski

& Aiken, 1999). After the weaning of urinary catheter after operation, nurses are

capable to determine if the patient is eligible for the protocol and have the freedom to

terminate the PFMT program anytime when they consider it is no longer desirable to

the selected participants. Nurses would have full autonomy to manipulate the

innovation according to their professional judgement.

3.4.2 Workload of nurses & administrative and organizational support

As it is a usual practice for all prostate cancer patients who underwent radical

prostatectomy to have one-to-one nurse consultation sessions once pre-operatively

and have regular follow-ups post-operatively to explain the pathophysiology,

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prognosis, and peri-operative care, no extra man power is needed for adding PFMT

into each session. Yet, nurse who in-charge of the consultation session would need to

spend an extra 20-30 minutes to guide patient to perform PFMT, this would slightly

increase the workload of the responsible nurse.

It is grateful that the GMN, ward manager and urologists in the target setting are very

supportive in promoting staff to conduct research and adopt evidence-based practice

so as to improve patient outcome. There is also a self-initiated journal club organized

by frontline nurses in the ward. Nurses constantly print out relevant journals for other

colleagues to read and willing to share updated reviews related to males urology

among staff. Considered the full support from the administrative team and educational

organizational climate, it is believed that this easy-to-implement innovation would not

cause job burnout to nurses and will be likely approved by administrative parties.

3.4.3 Facility & education tool

Under current practice, the patients normally visit the nurse in a conference room just

outside the ward per- and post operatively. However, part of the exercises required the

patients to hold the pelvic floor muscles in supine position, but there is no bed

available for them to lie on in the conference room. Approval from ward manager on

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changing the location of consultation to the treatment room in ward, where bed is

available, is needed. Nevertheless, pamphlets on PFMT with written instruction,

bladder dairy and exercise log have to be prepared. Besides these, no extra education

tool is needed.

3.4.3 Interfere to patients

If the patients is eligible for the PFMT program, approximately an additional of 20-30

minutes is thought to be reasonable in each pre-existing visit. There is no apparent

interfere to embedded such PFMT in the consultation session. All recruited

participants should be mentally fit and able to follow instructions, therefore, under the

supervision of professional nurses, it is believed that they would be able to acquire the

skills. Also, they always reserve the rights to withdraw from the innovation at any

time. As recruited participants should be ambulatory, therefore changing the location

of visit from conference room to treatment room inside the same ward should not

cause any inconvenience to them.

3.4.4 Potential barriers & strategies to overcome

Until now, the proposed protocol looks feasible for nurses to implement, yet, two

potential barriers need careful attention when planning for implementation.

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1. New skill required by nurses

Nurses may have lack confidence in initiating the intervention. Special trainings for

the pelvic floor muscles exercise has to be provided for the nurses in the preparation

period in order to increase their self-confidence and control over the program. The

protocol for the PMFT should make simple, easy to follow and not time consuming to

read. Pamphlets with written instructions will also be provided to both patients and

nurses for more comprehensive understandings to the proposed innovation. It is

believed that the continuity of care and the new protocol implemented by case nurses

will improve patient outcome, as well as nurses’ job satisfaction.

2. Resistance to change

Resistant to change is expected to be a normal reaction during the changing process

(Kohles, Baker & Donaho, 1995). Some nurses may embrace change whilst some

may resist it. To prevent unnecessary resistant to change, ward manager and advanced

practice nurses should have extra support and reassurance to frontline nurses during

the stage of change.

All level of staff should have clear direction and goal towards the proposed protocol.

Advance practice nurses and senior nurses will be arranged to roll out the innovation

first and then step down, so as to motivate the frontline nurses to embrace the new

innovation and align with the change.

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3.5 Cost-benefit ratio of the innovation

Considered the scarce resources, the cost in relation to benefit of the innovation is

discussed thoroughly in this session in order to guide decision making on proper resource

allocation.

3.5.1 Tangible Cost

Nurses will be well-trained by physiotherapist before the implementation. It is

believed that five identical trainings would be enough to cover all nurses in the ward.

The hourly rate for a senior physiotherapist (pay scale point 25) is around $245, five

1-hour trainings would cost HKD $1225, which is affordable by the department.

General expenses spend on printing PFMT pamphlets, bladder dairy and exercise

diary are required for supplementing the PFMT program. However, such extra

document cost is minimal, it is estimated that each patient costs around 14 pages of

papers for such printing materials, i.e. $1@ x 14 = HKD $14. For the location, the

program will be designated in the treatment room in ward, therefore, no extra cost is

needed.

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3.5.2 Intangible cost

No extra staff is needed for adding PFMT into the existing nurse consultations per-

and post-operatively. The only intangible cost is that patients and nurses would need

an addition of 20-30 minutes for the PFMT in each of the seven consultation sessions.

Yet, the consultation session is only on monthly basis. With a projection of 30 targeted

patients per year (2 to 3 cases per month), that could only cost at most 1.5 hours extra

work to nurses per month, which would not be excessively time-consuming for

nurses.

3.5.3 Potential risks

There is no apparent potential risks reported in all the reviewed studies. Generally the

PFMT is safe and easy to implement. Some patients may experience fatigue on

abdominal or back muscles if they try too hard to contract these muscles instead of

pelvic floor muscles. They may also experience tense on chest muscles if breath is

hold during the contraction. With the supervision of PFMT by professional nurses,

patients will be monitored and reinforced on the correct contraction of muscles and

breathing coordination.

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3.5.4 Potential benefit for patients

Patients could save the cost for purchasing products to manage urinary incontinence,

e.g. pads, napkins. The incontinence pads for men typically cost HKD $10 per pack.

Evidence from the reviewed studies showed that PFMT is effective in reduction of

incontinence episodes from eight to ten times per week (Goode et al., 2011; Tienforti

et al., 2012). Excluding other incontinence products, i.e. barrier cream, it is estimated

that patients who benefit from the program could save at least HKD $320 per month

from reduced use of incontinence pads.

Besides the above tangible benefit from the PFMT program, patients would also be

benefit from both reduced physical and emotional pain and suffering. The risk of

urinary tract infection and the skin problems resulted from constant wet skin during

persistent incontinence could be eliminated when patients restore continence. Normal

functioning could also be gradually restored with the reduction of incontinence

severity. Patients would have less emotional burden and social isolation. These

potential benefits from the low risk PFMT could ultimately improve patients’ quality

of life, which is undoubtedly a priceless gift for all prostate cancer survivors.

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3.5.5 Potential benefit for nurses

In usual practice, significant amount of time is used in offering advice on managing

urinary symptoms and explaining the alternative treatment options for patients with

persistent urinary incontinence. The successful of the program would actually be able

to release nurses, and allow them re-allocate their time and resources.

The autonomy and contribution of nurses to help patients in achieving continence

would also increase their motivation to sustain the program and increase their moral.

The effort made by nurses to improve patients’ outcome would also increase caring

nurses’ awareness and the willingness to communicate with the patients who need

bladder control.

3.5.6 Potential benefit for hospital organization

The cost for invasive therapy using urinary catheters, male slings and artificial urinary

sphincter as management of persistent urinary incontinence could be saved. The

successful of PFMT program would have the benefit of reducing the need for these

expensive invasive intervention.

Persistent urinary incontinence is also shown to increase the risk of urinary tract

infection, rash and skin problem related to diaper use, the cost of treating these

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complications using antibiotics, topical cream is profound and could be reduced.

Moreover, with the PFMT program, the cost and workload for frequent SOPD visits

due to incontinence complications could be greatly reduced.

3.5.6 Conclusion

The proposed protocol is both transferable and feasible to implement in the target

setting. The chance for implementation is high with the organizational, administrative

and nurses’ support. The potential risk for this easy-to-learn PFMT is minimal.

Considered the cost and benefit ratio, as summarized in Appendix 12, the overall cost

for the protocol is low while there are profound benefits for both patients, nurses and

hospital. The achievable, affordable and cost-effective of the protocol have provided

strong reasons for implementing it to reduce the severity of urinary incontinence of

prostate cancer patients.

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Chapter 4: Developing evidence-based practice guideline

An evidence-based practice guideline, aiming to reduce the severity of urinary

incontinence in prostate cancer patients who underwent prostatectomy, is developed

in this section based on results of critical appraisal discussed in Chapter 2.

The level of evidence and grade of recommendations for the protocol are assessed

according to the Scotthish Intercollegiate Guidelines Network (SIGN) grading system

(2014). The levels of evidence ranges from 1++ to 4, while the grades of

recommendations ranges from A to D. The details explanation the grading system is

shown in Appendix 13.

4.1 Name of evidence-based practice guideline

An evidence-based guideline of using pelvic floor muscle training in reducing the

severity of urinary incontinence in prostate cancer patients after having radical

prostatectomy.

4.2 Objectives

1. To describe evidence-based PFMT program for reducing urinary incontinence

of patients underwent radical prostatectomy.

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2. To summarize the clinical evidence for introducing PFMT in urology ward to

reduce the severity of urinary incontinence after radical prostatectomy.

3. To streamline and standardize the PFMT protocol to reduce urinary

incontinence related cost and complications.

4.3 Target audience

- Male patients who diagnosed with localized prostate cancer (stage T1 or T2);

- Admitted for elective radical prostatectomy;

- Patients must be mentally fit, able to follow instructions, ambulatory and

urinary continence before operation.

4.4 Intended users

Urology case nurses with the following characteristics, who in-charge of elective

radical prostatectomy patients in the urology ward of Department of Surgery will be

the intended users.

- Registered nurse(s)/ advance practice nurse(s);

- At least 2 years of experience in urology nursing care;

- Received training on PFMT;

- Endorsed to be the in-charge case nurse of the participant.

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4.5 Recommendations

Assessment

Recommendation 1

Assess patient’s intact mental status before teaching PFMT by Mini-Mental State

Examination (MMSE) is vital to ensure successful delivery of PFMT instructions.

Evidence

Impaired mental status would disable the participants from understanding and

following the instructions taught by nurses during the visits. Individuals with MMSE

scored below 30 is unlikely to be benefit from the PFMT program (Goode et al., 2011;

Centemero et al., 2010; Filocamo et al., 2005; Burgio et al., 2006) [level of evidence

1++; 1++; 1-, 1++].

Grade of Recommendation: A

Recommendations 2

Subcostal digital assessment can be used to assess the correct contraction of pelvic

floor muscles and the muscle strength during the supervised pelvic floor muscle

training.

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Evidence

After radical prostatectomy, most patients encountered compromised function of the

pelvic floor muscles causing urinary incontinence. Feedback should be given to

patients to reinforce how to control pelvic floor muscles for contraction with

abdominal muscles relaxed. The reviewed quality studies suggested the use of

subcostal digital assessment to evaluate the contraction and relaxation of pelvic floor

muscles in order to ensure that correct groups of muscles were trained (Centemero et

al., 2010; Filocamo et al., 2005) [level of evidence 1++; 1-].

Grade of Recommendation: A

Intervention

Recommendation 3

The supervised PFMT program should be initiated the day before operation and

resumed after urinary catheter removal and then continued on monthly basis up to

6-months.

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Evidence

Tienforti et al. (2012) [level of evidence 1+] and Burgio et al. (2006) [level of

evidence 1++] both stated that providing PFMT the day before operation enabled

patients to practice new motor skills before operations under no pain. It also allowed

patients to be more prepared on the correct use of pelvic floor muscles and train them

once urinary catheter is removed.

For the timeframe of PFMT, Tienforti et al. (2013) [level of evidence 1+] showed that

the PFMT training was most effective in the first two months onwards and up to six

months after operation. They also suggested that monthly visits of supervised training

after operation could maintain adherence to the pelvic floor muscle training and

ensure correct skills of PMFT demonstrated.

Grade of Recommendation: A

Recommendation 4

The supervised PFMT program included education of basic urinary anatomy,

breathing coordination, repetitive contraction and relaxation of pelvic floor muscles

voluntarily (sitting, standing, supine position) and home pelvic floor muscle exercises

with pamphlet given.

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Evidence

Education of basic anatomy of pelvic floor and bladder allowed patients to understand

the reasons and mechanisms of their urinary incontinence. The understanding on how

urination works normally by controlling proper the pelvic floor muscles could

empower patients that their role in the treatment process is vital. The positive

ascertainment of their ability to reduce the severity of urinary incontinence drives

them to learn new skills and engage in home pelvic floor muscle exercises until they

regain continence. The commitments and compliance with the PFMT program could

also be motivated. The taught pelvic floor muscle exercise should be continued at

home, 3 times daily with 10-15 repetitions of two to ten seconds contraction and

relaxation alternatively (Goode et al., 2011; Tienforti et al., 2012; Centemero et al.,

2010; Filocamo et al., 2005; Burgio et al., 2006) ) [level of evidence 1++;1+;1++;1-;

1++]. Pamphlet on pelvic floor muscle exercise also served as written instructions to

consolidate patients' PFMT skills and increase their compliance (Tienforti et al., 2012)

[level of evidence 1+].

Grade of Recommendation: A

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Evaluation

Recommendation 5

Bladder dairy and exercise log can be used to evaluate compliance and continence

status.

Evidence

Patients were instructed to document every void, incontinence episodes and the

completion of daily PFMT using bladder diary and exercise diary starting from the

day before operation. The use of bladder diary was omitted when urinary catheter is

inserted after operation. Once catheter was removal, patients were instructed to

resume PFMT and documentation. The bladder diary would be reviewed by case

nurses when patients returned for regular ward-follow-ups after discharged. Tracking

of compliance of PFMT, evaluation of continence status and micturition pattern were

ensured using bladder and exercise log (Goode et al., 2011; Tienforti et al., 2012;

Centemero et al., 2010; Burgio et al., 2006) [level of evidence 1++;1+;1++;1++].

Grade of Recommendation: A

50 | P a g e

Chapter 5: Implementation Plan

Evidence-based protocol on pelvic floor muscle training (PFMT) in reducing the

severity of urinary incontinence for prostatectomy patients was thoroughly discussed

in previous chapter. In order to enhance the successful delivery of the PFMT to

clinical setting, comprehensive implementation plan should be established to solicit

the views from all relevant stakeholders and ensure sufficient communication among

them.

5.1 Communication plan

5.1.1. Identification of stakeholders

Engaging stakeholders during all stages of the new program can greatly assist in

successful program design, program rollout and establishment of long term support

for the program (Torres, Preskill, & Piontek, 2014). Key stakeholders must therefore

be identified comprehensively so that the PFMT program could be successfully

implemented.

The key stakeholders include the in-charge personals of the medical and nursing team

in the urology ward. Ward Manager (WM), General Nursing Manager (GMN) and

Chief of Service (COS) are important key stakeholders who have the authority to

approve the rollout of protocol and allocate resources needed.

51 | P a g e

Besides the in-charge parties mentioned, other stakeholders who are responsible for

direct medical treatment of the target group should also be involved. Urology

consultants and Medical Officers (MO) are important to collaborate in taking care of

post-prostatectomy patients with the new protocol.

Other parties who are responsible for supervising the quality of nursing care should

also be the key stakeholders. The urology case manager, Nursing Specialist (NS) and

Advance Practicing Nurses (APN) are essential for providing constructive advices and

monitoring, so as to make the implementation of protocol practicable and feasible in

the urology ward.

Other important key stakeholders are those who are responsible for executing the

PFMT program. The frontline nurses in the urology ward serve as an important role in

including eligible patients into the program, teaching them pelvic floor muscles

exercise, assessing patients’ progress and evaluating the outcome. They can also

provide timely feedback for protocol modification if needed.

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5.1.2. Communication plan with administrators

Senior nurses who work in urology ward have profound experience and knowledge

related to the care for prostatectomy patients. Their advices on the proposed protocol

are valuable in assisting the identification of existing problem and the amendment of

the preliminary protocol. Their advices will be collected through several informal

discussions in the communication plan.

Although the advices from senior nurses are important, the concerns from frontline

nurses should not be missed. Fear to master new skill and uncertainty to the new

protocol may be the reason for urology frontline nurses to resist to change. Meeting

will be held to explain the goal, cost and benefit of the protocol based on the reviewed

studies. The arrangement and nature of PFMT learning will be explained clearly so as

to reassure them that with their professional background, learning how to execute

PFMT will not be a real challenge for them. The meetings also provide opportunities

for them to voice out their concerns.

With the consensus among the frontline nurses, the aims, significant, affirming needs,

cost and benefit of the proposed proposal will then be presented to the urology case

manager, NS and APN. The reasons and methods of translating the nursing research

53 | P a g e

into current practice will be explained in details with tables of evidence of the

reviewed studies and strength of evidence. The timeframe, inclusion and exclusion

criteria, implementation potential, transferability and feasibility of the protocol and

the outcome measures of the PFMT program will also be explained with a

comprehensive report submitted. Being the clinical advisors of the urology ward, they

are capable to provide constructive clinical advice to streamline the protocol,

propagate the protocol with other stakeholders and promote the frontline nurses to

execute it.

After the streamline of the protocol, the refined protocol will be presented to the WM

for the approval of project. The existing problem, gaps between the current practice

and the new innovation, proposed evidenced-based guideline, transferability,

feasibility and cost-benefit ratio of the protocol will be explained.

With the approval of urology ward in-charge person, a formal report for implementing

PFMT to post-prostatectomy patients in urology ward will be presented to COS and

GMN in a thirty minutes formal meeting chaired by WM, urology case manager, NS

and APN. All important information and recommendations related to the protocol will

be highlighted and delivered to them with a printed outline. The support and approval

54 | P a g e

from the administrative team is a milestone for the implementation of the proposed

protocol.

5.1.3 Communication with urology physicians

Urology consultants and medical officers who are responsible for the medical care of

the post-prostatectomy patients will be invited to a meeting with WM, urology case

manager and NS for explaining the aim, benefit to patients and the feasibility of the

protocol after the approval of administrative parties. Medical considerations and

professional opinions regarding the protocol will be welcomed. Refinement of

protocol may be needed, if necessary.

5.1.4 Set up of steering committee

An implementation committee on PFMT will be set after obtaining the approval from

administrative parties. The members of committee will include one NS and three

frontline nurses who have completed the PRCC in Urology. My role will be the

planner and coordinator of the Committee. Meeting will be held, content and

execution plan of the protocol will be explained by the coordinator to other members

of the committee. The consensus for the recommendations of innovation will be

sought. The committee is also responsible for the followings:

(i) To steer and develop strategic directions for promoting PFMT in urology ward;

55 | P a g e

(ii) To provide support during the implementation of innovation;

(iii) To monitor and evaluate progress of PFMT program;

(iv) To communicate with relevant stakeholders, including administrative parties,

urology doctors, nurses, etc.

Regular committee meetings will be held monthly for the first three month and then

bi-monthly afterwards. Urology physician and WM will join the meeting every three

month to update the progress and provide opinions, if any.

5.1.5 Communication with frontline nurses

In order to eliminate the barriers for protocol rollout, the inadequacy of the current

practice, aim and content of the new protocol should be clearly explained to all

frontline nurses in weekly ward meetings. The five reference studies will be kept in

Journal Club’s folder in ward so that nurses could assess to them anytime. To promote

the implementation of protocol, pamphlets regarding PFMT with clear graphical

illustration with textual description will also be provided to the frontline nurses.

Concerns or opinions from frontline nurses will be welcomed by the steering

committee. To encourage frontline nurses to express the feelings, anonymous opinions

collection sheet will be posted in the ward so that nurses will be more willing to

express their concerns without pressure.

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Five identical pelvic floor muscles trainings held by physiotherapist will be provided,

frontline nurses will be allowed to join any of these sessions during office hours. With

the professional knowledge of nurses, it is believed that all nurses will be competent

to acquire the PFMT skills in one month. Besides, the introduction of innovation, the

orientation of enrollment process, assessment method, evaluation tools and

documentation will also be introduced by the steering committee after each training.

Post-training questionnaire and return demonstration will be used as the process

evaluation to assess the appropriateness of trainings and their competent of nurses to

roll out the innovation.

5.1.6 Monitoring and sustaining the change

After the roll out the innovation, effort shall be put to sustain the protocol by the

steering committee. Compliance to the protocol will be monitored with the audition of

program execution related documents. The opinions collected from all parties will be

addressed in the regular meetings of the steering committee. The difficulties

encountered by frontline nurses and the possible solutions for them will also be

discussed in weekly ward meetings.

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Chapter 6: Pilot testing plan

A pilot test is used for preliminary analysis before proceed to the full run of

innovation (Polit & Beck, 2010). In order to test for the feasibility of program, pilot

test will be conducted in the urology ward for three months. Data collected in pilot

study will be analyzed, revision of protocol will be made accordingly to ensure the

protocol is feasible to the target setting.

6.1 Objectives of the pilot test

The objectives of the pilot test are as follows:

1. To test for the feasibility of the protocol in urology ward;

2. To identify potential problems occurring during implementation;

3. To revise the protocol if necessary according to the feasibility in the pilot test.

6.2 Study design

The pilot test will be conducted for three months in the urology ward. According to

the statistics in hospital, there will be around seven to eight eligible target patients

admitted to the urology ward for prostatectomy every three months. Hence, the

sample size of the pilot test is estimated to be seven. Consent will be obtained from

58 | P a g e

the participants who meet the inclusion and exclusion criteria for agreeing to join the

pilot study voluntarily.

6.3 Data collection and analysis

Assessment

After the recruitment of participant, the baseline characteristics including age, mental

status, urinary continent status and ambulatory condition before radical prostatectomy

will be assessed and recorded.

Intervention & data collection

Supervised pelvic floor muscle training program will be provided to participants

undergoing prostatectomy. Bladder dairy and exercise logbook will be used to record

the continence status after surgery and the compliance of performing PFMT at home.

Feedbacks from patients regarding the new innovation will be collected by

satisfaction surveys for data analysis and evaluation. The reasons for participants to

drop out of the pilot study, if any, will also be analyzed.

Data on the incidence and severity of urinary incontinence collected in the pilot study

will be analyzed and compared with the selected studies to examine the feasibility of

the protocol.

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The satisfaction and acceptability of nurses towards the recruitment process,

assessment and evaluation tools, and program implementation during the pilot test

will be assessed by questionnaires. During regular ward meetings, nurses will also be

encouraged to share their views and difficulties encountered. The cost for executing

the protocol will be recorded for further budget evaluation.

Evaluation

The data collected from the pilot test serves as important parameters for

re-modification of protocol, thus, increase the feasibility of implementing the new

innovation in urology ward. The identified logistics or technical problems, satisfaction

and compliance of participants, acceptability and competency of staff and the actual

cost of the protocol will be discussed in the steering committee and ward meetings.

Modification of protocol will be made after evaluating the results of the pilot test.

Report of the pilot test will be presented to the in-charge stakeholders. The optimized

protocol will be used in the ward as usual practice in long run.

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Chapter 7: Evaluation plan

Evaluation plan describes how the PFMT program will be monitored and evaluated,

as well as how evaluation results will be used for program improvement and decision

making on long-term program planning (Patton, 2008). This evaluation plan details

the outcome to be achieved, method for data collection and analysis, and sample size

calculation. The effective criteria for protocol to be implemented in long term will

also be discussed. The timeframe of communication plan and evaluation plan is

presented in a table (Appendix 14).

7.1 Identifying outcomes to be achieved

7.1.1 Outcome for effectiveness evaluation

The aim of this protocol is to reduce the severity of urinary incontinence in prostate

cancer patients after having radical prostatectomy. 7-day bladder dairy and PFMT

exercise log will be used for assessing the incontinence severity and the frequency of

practicing pelvic floor exercise at home. The reduction of the number of urinary

incontinence episodes per week will be the primary outcome in determining the

effectiveness of the intervention.

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7.1.2 Outcomes for qualitative/ process evaluation

Acceptance and satisfaction of both patients and healthcare providers towards the

PFMT program are the important secondary outcomes to be achieved.

The patient satisfaction level towards the PFMT program will be assessed by

self-developed questionnaire (Appendix 15). The easiness to learn and practice pelvic

floor muscles exercise, the venue arrangement, the duration of the program, and the

satisfaction towards the supervision of nurses in the program will be considered in the

overall patient satisfaction survey.

The satisfaction of nurses towards the PFMT will be assessed based on the following

domains in the self-developed questionnaire: i) objectives achievement; ii) content

practicability; iii) content appropriateness; iv) satisfaction of the implementation plan,

in a self-developed questionnaire (Appendix 16).

An open-ended question will be set at the end of both questionnaires for patients and

nurses to express their feelings or comments towards the program. Besides, some of

the patients and nurses involved in the program will be randomly selected for

interview, the difficulty encountered and recommendations for improvement will be

collected for further evaluation.

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7.1.3 Outcome for cost/ risk evaluation

The cost-effectiveness of the protocol will also serve as an important determinant in

program outcome. The cost on training, document, printing materials and any extra

manpower needed will be calculated. Evaluation will be conducted to assess if any

additional cost is spent unexpectedly.

Although the risk of PFMT is not apparent in reviewed studies, any adverse event

occurred due to the program will be documented and evaluated.

7.2 Data collection

After explaining the purpose of the program, written consent from patients about

subcostal digital examination needed for assessing correct pelvic floor muscles

contraction will be obtained. Supervised pelvic floor muscles trainings will be then

conducted the day before radical prostatectomy and continued monthly up to 6

months after urinary catheter removal. The baseline characteristics including age,

mental status, urinary continent status and ambulatory condition before radical

prostatectomy will be collected. Data on the number of urinary incontinence episodes

will be collected using a 7-day bladder diary with exercise log at 1, 3 and 6 months.

The bladder diary and exercise log recorded by participants will be comprised with

63 | P a g e

the numbers of self-voiding, episodes of urinary leakage and the frequency of

performing pelvic floor muscles exercise at home.

For formative and summative evaluation on the patient’s satisfaction towards the

program, a self-developed 5-point Likert Scale questionnaire will be distributed to

participants at 3-month and at the last training session of the program (Appendix 15).

The score for each of the six questions is 1 = strongly disagree, 2 = disagree, 3 =

neutral, 4= agree, 5= strongly agree. The score of questionnaire ranges from 6 to 30,

the higher the score, the higher the satisfaction level towards the intervention.

The satisfaction level of nurses will also be assessed by a self-developed 5-point

Likert Scale questionnaire at 3-month and at the end of the program (Appendix 16).

The rating is also from 6 to 30 (1 = strongly disagree, 2 = disagree, 3 = neutral, 4=

agree, 5= strongly agree), the higher the score, the better the satisfaction towards the

program.

The costs of the protocol will be documented in the program expenditure chart by the

steering committee and frontline nurses, starting from the stage of program planning

till the end of program.

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7.3 Data analysis

The significance level of p < 0.05 will be used for data analysis in this study. Data

entry and analysis will be processed using Statistical Product and Service Solutions

(SPSS) version 20. Descriptive statistics will be used to describe the frequency and

percentages of all baseline characteristics variables, frequency of practicing PFMT

and the number of urinary incontinence episodes per week for each

post-prostatectomy patient.

Furthermore, the scores from the satisfaction questionnaires for both patients and

nurses will be described by mean and standard deviation with frequency tables to

display their responses to each item. The qualitative comments collected from the last

question of the questionnaire will be recorded and analyzed for future improvements.

The tangible cost and intangible cost in this program will be analyzed and compared

with current practice. The possibility of over-budget, overwhelming manpower or

resources will be analyzed and evaluated.

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7.4 Nature and number of patients involved

The number of patients involved in the evaluation plan will be the same as the eligible

patients enrolled into the program and will be determined by the availability of

subjects in the targeted setting.

The number of recruited subjects in the reviewed studies ranged from 38 to 300. All

studies showed that PFMT has significantly reduced urinary incontinence episodes

compared to no PFMT, despite the variety of sample size. According to the admission

statistics, there were around seven eligible cases admitted to the urology ward every

three months. Based on the available and affordable of subjects, nine months is a

sound frame for evaluation, thus, the number of patients involved will be

approximately 21.

7.5 Basis for implementation of protocol

Reduction on the number of incontinence episodes, the satisfaction of patients and

nurses towards the innovation and the ability to implement the program within budget

will be the essential bases for successful rollout of the PFMT program. Each of these

bases must be fulfilled in order to consider a full implementation of the innovation in

the urology ward.

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7.5.1 Reduction on the number of incontinence episodes

According to Goode et al. (2011), there was a reduction of eight incontinence

episodes per week in post-prostatectomy patients with the help of PFMT compared to

the group without PFMT at 2-months follow-up. Similarly, Tienforti et al. (2012) also

found that there was around ten episodes reduction of urinary incontinence per week

in PFMT group in 3-months and 6-months follow-ups. The reduction of number of

incontinence episodes is not only statistically effective, but also clinical effective and

applicable. Therefore, the protocol will be considered as successful if there is a

reduction of urinary incontinence episodes by at least eight times per week at 3

months follow-up and the result is sustained up to 6 months follow-up after the

protocol implementation.

7.5.2 Satisfaction of patients and healthcare providers

Although the effectiveness of program is important, the satisfaction of patients and

nurses are also essential. Without their contributions to the program, PFMT will be

unlikely to benefit any of them. The satisfaction level of patients and nurses will be

assessed, the mean score of 4 or above in the questionnaire indicates satisfaction

towards the program. The PFMT program will be continued if more than 70% of the

67 | P a g e

patients and nurses are satisfy with it. The comments or suggestions collected will be

further evaluated for future improvement of the protocol.

7.5.3 Cost and utilization

Lastly, considered the approval from administrative parties for continuous

implementation of the protocol, cost will be of great concern. It is important to ensure

that resources are fully utilized and the protocol is on budget. The percentage of target

population that have completed the program will be an important parameter that

shows the utilization of the program and manpower. Therefore, another basis for

implementation of the protocol will be there is more than 90% of patients who have

completed the program and the program is delivered within the funding allocated by

hospital.

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Chapter 8: Conclusion

Although radical prostatectomy is a gold-standard treatment for men with localized

prostate cancer (stage T1 or T2) in Hong Kong, urinary incontinence is still a common

post-operative complication that imposed severe negative impact to the healthcare

system and prostate cancer survivors. Nevertheless, existing literature strongly

supported that early pelvic floor muscle training (PFMT) is effective and should be

considered as the first-line treatment for post-prostatectomy incontinence.

In this paper, an evidence-based clinical guideline on PFMT in reducing the severity

of urinary incontinence in prostate cancer patients after having radical prostatectomy

was established according to the critical appraisal of five high-quality studies.

The implementation potential for the proposed guideline is high, and it is transferable

and feasible for the target setting, i.e. one of the urology wards in a local public

hospital. A comprehensive communication plan for stakeholders is also developed in

assisting the successful implementation of the protocol. A 3-month pilot study is

proposed for preliminary analysis and program re-modification before proceed to the

full run of innovation.

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The ultimate gold for PFMT protocol is to reduce the severity of incontinence in men

after radical prostatectomy. For the full implementation of the innovation, the

reduction on the number of incontinence episodes, the satisfaction of patients and

nurses towards the innovation and the ability to implement the program within budget

must be fulfilled.

The successful implementation of the protocol will have profound potential benefit to

the patients undergoing prostatectomy, nurses and hospital organization. Therefore,

further clinical trials are urgently needed for this achievable, affordable and

cost-effective intervention.

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References Burgio, K.L., Goode, P.S., Urban, D.A., Umlauf, M.G., Kicher, J.L., Bueschen, A. & Redden,

D.T. (2006). Preoperative biofeedback assisted behavioral training to decrease

post-prostatectomy incontinence: A randomized controlled trial. Journal of Urology, 175,

196-201.

Centemero, A., Rigatti, L., Giraudo, D., Lazzeri, M., Lughezzani, G., Zugna, D., Montorsi, F.

& Rigatti, P. (2010). Preoperative pelvic floor muscle exercise for early continence after

radical prostatectomy: A randomized controlled study. European Urology, 57, 1039-1044.

Chan, S.W.H., Lam, K.M., Kwok, S.C. Yu, C., Au, W.H., Yung, Y.P., Mah, I.S.F., Chu,

P.S.K. & Man, C.W. (2008). Laparoscopic radical prostatectomy: single centre experience

after 5 years. Hong Kong Med Journal, 14 (3).

Currie, V., Harvey, G., West, E., McKenna, H. & Keeney, S. (2005). Relationship between

quality of care, staffing levels, skillmix and nurse autonomy: literature review. Journal of

Advanced Nursing, 51(1), 73-82.

Filocamo, M.T., Marzi, V.L., Popolo, G.D., Cecconi, F., Marzocco, M., Tosto, A. & Nicita, G.

(2005). Effectiveness of early pelvic floor rehabilitation treatment for post-prostatectomy

incontinence. European Urology, 48, 734-738.

Fu, Q., Moul, J.W. & Sun, L. (2011). Contemporary radical prostatectomy. Prostate Cancer,

2011, 13.

Goode, P.S., Burgio, K.L., Johnson, T.M., Clay, O.J., Roth, D. L., Markland, A.D., Burkhardt,

J.H., Issa, M.M. & Lloyd, L.K. (2011). Behavioral therapy with or without biofeedback

and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: A

randomized controlled trial. Journal of American Medical Association, 305(2),151-159.

71 | P a g e

Higa, R., Lopes, M.H.B. & D'Ancona, C.A.L. (2013). Male incontinence: a critical review of

the literature. Text Context Nursing Florianópolis, 22(1), 231-238.

Hong Kong Cancer Registry. (2009). Hong Kong cancer stat 2007. Retrieved March 2, 2016

from The Hospital Authority, The Hong Kong Cancer Registry Web site:

http://www3.ha.org.hk/cancereg/e_canstat2007.pdf

Hong Kong Continence Society. (2013). Advances in Surgical Treatment of Urinary

Incontinence. Retrieved May 14, 2015 from http://www.hkcs.hk/newsletter/1312.pdf.

Hospital Authority. (2012). Hong Kong Cancer Registry. Retrieved May 14, 2015 from

http://www3.ha.org.hk/cancereg/statistics.html

Hospital Authority. (2016). Vision, Mission and Values. Retrieved March 3, 2016 from

https://www.ha.org.hk/visitor/ha_visitor_text_index.asp?Content_ID=10009&Lang=ENG

&Dimension=100&Parent_ID=10004&Ver=TEXT

Hunter, K.F., Glazener, C.M. & Moore, K.N. (2007). Conservative management for

postprostatectomy urinary incontinence. Cochrane Database of Systematic Reviews, 15(2),

16-66.

Kakihara, C.T., Sens, Y.A.S., & Ferreira, U. (2007). Effect of functional training for the

pelvic floor muscles with or without electrical stimulation in cases of urinary incontinence

following radical prostatectomy. Brazilian Journal of Physical Therapy, 11(6), 481-486.

Kohles, M.K., Baker, W.G., & Donaho, B.A. (1995). Transformational leadership: Renewing

fundamental values and achieving new relationships in healthcare. The Journal of

Nursing Administration, 28, 141-146.

72 | P a g e

Nilssen, S.R., Morkved, S., Overgard, M., Lydersen, S. & Angelsen, A. (2012). Does

physiotherapist-guided pelvic floor muscle training increase the quality of life in patients

after radical prostatectomy? A randomized clinical study. Scandinavian Journal of

Urology and Nephrology, 46(6), 297-404.

MacDonald, R., Fink, H.A., Huckabay, C., Monga, M. & Wilt, T.J. (2007). Pelvic floor

muscle training to improve urinary incontinence after radical prostatectomy: a systematic

review of effectiveness. BJU International, 100(1), 76-81.

Patton, M.Q. (2008). Utilization-focused evaluation (4th ed.). California: Sage Publications.

Polit, D.F. & Beck, C.T. (2010). Essentials of nursing research: Appraising evidence for

nursing practice. Pennsylvania: Lippincott Williams & Wilkins.

Scott, J.G., Sochalski, J. & Aiken, L. (1999). Review of magnet hospital research: Findings

and implications for professional nursing practice. Journal of Nursing Administration,

29 (1), 9-19.

Scottish Intercollegiate Guidelines Network (2014). Critical appraisal: Notes and checklists.

Healthcare Improvement Scotland. Retrieved March 1, 2016, from

http://www.sign.ac.uk/methodology/checklists.html.

Serdà, B.C. & Marcos-Gragera, R. (2014). Urinary incontinence and prostate cancer: a

progressive rehabilitation program design. Rehabilitation Nursing, 39, 271-280.

73 | P a g e

Tienforti, D., Sacco, E., Marangi, F., D'Addessi, A., Racioppi, M., Gulino, G., Pinto, F.,

Totaro, A., D'Agostino, D. & Bassi, P. (2012). Efficacy of an assisted low-intensity

programme of perioperative pelvic floor muscle training in improving the recovery of

continence after radical prostatectomy: A randomized controlled trial. BJU International,

110(7), 1004-1010.

To, K.C. & Yiu, M. K. (2011). Surgical treatment for localized prostate cancer disease. The

Hong Kong Medical Diary, 16(6).

Torres, R., Preskill, H. & Piontek, M.E. (2014). Evaluation strategies for communicating and

reporting (2nd ed). California: Sage Publications.

Trost, L. & Elliott, D.S. (2012). Male stress urinary incontinence: a review of surgical

treatment options and outcomes. Advances in Urology, 2012, 287-489.

74 | P a g e

Appendices

Appendix 1 – PRISMA flow diagram

From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and

Meta-Analyses: The PRISMA Statement. PLoS Med 6(7): e1000097. doi:10.1371/journal.pmed1000097

75 | P a g e

Appendix 2 - Table of Evidence (1):

Study type

Evi

denc

e le

vel

No.

of

patie

nts

Sample characteristics

Intervention groups Control

Length of

follow up

Outcome measures

Effect size (Intervention – Control)

Goode, P.S., Burgio, K.L., Johnson, T.M., Clay, O.J., Roth, D. L., Markland, A.D., Burkhardt, J.H., Issa, M.M. & Lloyd, L.K. (2011). Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: A randomized controlled trial. Journal of American Medical Association 305(2):151-159. RCT ++

208 1. White and

African American men at United States,

2. Mean age 66

(51-84) 3. Post radical

prostatectomy

Four sessions of therapy, 2 weeks apart 1. PFMT

without biofeedback (Group A) (n=70).

2. PFMT with

biofeedback (Group B) (n=70)

Delayed treatment (n=68)

i.e. offered treatment choice after 8 weeks

2 months

Primary: 1. No. of

incontinence episodes per week

Secondary: 2. QoL by

Condition specific quality of life (EPIC)

(1) Mean reduction of no. of incontinence episodes per week

Interpretation: PFMT with or without biofeedback both significantly reduced incontinence episodes compared with control. But there was no significant difference between two treatment groups Sample time, months

Group A - Control

Group B - Control

P-values

2 -8 -12 0.001

(2) Change in mean EPIC score Interpretation: Greater QoL improvement among treatment groups, i.e. feel less burden, than control. Urinary domain

8.9 5.8 <.001

Incontinence subscale

10.2 9.4 <.001

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Appendix 3 - Table of Evidence (2):

Study type E

vide

nce

leve

l N

o. o

f pa

tient

s Patient

characteristics

Intervention groups Control Length of

follow up Outcome measures

Effect size (Intervention – Control)

Tienforti, D., Sacco, E., Marangi, F., D'Addessi, A., Racioppi, M., Gulino, G., & Bassi, P. (2012). Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: A randomized controlled trial. BJU International, 110(7), 1004-1010. RCT + 38 1. Italian

2. mean age

63 (52-74)

3. Post-radical

prostatecto-my

PFMT with biofeedback with supervised oral and written instruction using diary (n=17) (one session of PFMT one day before surgery & reinforced monthly till 6 months)

Without formal education on PFMT (n=17)

6 months Outcome assessment at 1, 3 & 6 months

Primary: 1. Reduction of

no. of incontinence episodes per week

Secondary: 2. QoL by

IPSS-QoL scores

(1) Mean reduction of no. of incontinence episodes per week Interpretation: Intervention group has significantly reduced incontinence episodes compared with control. Sample time, months

Effect size P-values

1 -4 n.s 3 -10.16 0.01 6 -10.34 0.005

(3) Change in IPSS-QoL scores Interpretation: Intervention group reported better QoL than control group

Ix - Control P-values 1 -1 0.08 3 -1 0.1 6 -1 0.06

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Appendix 4 - Table of Evidence (3):

Study type E

vide

nce

leve

l

No.

of

patie

nts

Patient characteristics

Intervention

group

Control

Length of follow up

Outcome measures

Effect size (Intervention – Control)

Centemero, A., Rigatti, L., Giraudo, D., Lazzeri, M., Lughezzani, G., Zugna, D., Montorsi, F. & Rigatti, P. (2010). Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: A randomized controlled study. European Urology, 57, 1039-1044. RCT ++

118 1. Italian

2. mean age Ix:

60.5 (48-68); mean age control 57.5 (46-67)

3. Prostate

cancer with radical prostatectomy

PFMT educated pre- and post- operatively (n=59)

Post-operative education only (n=59)

At 1 month and 3 months following radical prostatecto-my

Primary: 1. % (n)

patients of recovery of continence

Secondary: 2. QoL by

ICS male SF

(1) % (n) of continence patients with fully recovery Interpretation: Around 20% more participants with PFMT pre-op regain continence earlier than control Sample time, months

Effect size P-values

1 23.8% (14) . 018

3 22% (13) .028

(2) Mean change in ICS male SF score Interpretation: Greater QoL improvement among treatment groups than control. 1 -3.7 0.002

3 -4.1 0.002

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Appendix 5 - Table of Evidence (4):

Study type E

vide

nce

leve

l

No.

of

patie

nts

Patient characteristics

Intervention Control

Length of

follow up

Outcome measures

Effect size (Intervention - Control)

Filocamo, M.T., Marzi, V.L., Popolo, G.D., Cecconi, F., Marzocco, M., Tosto, A. & Nicita, G. (2005). Effectiveness of early pelvic floor rehabilitation treatment for post-prostatectomy incontinence. European Urology, 48, 734-738. RCT -

300 1. Italian

2. Mean age

66.8 (45-75)

3. Prostate cancer after radical prostatectomy

PFMT alone (3 sessions)

No pelvic floor muscle instruction

1, 3, 6, 12 months

Primary: 1. % (n)

patients of recovery of continence

1. % (n) of continence patients with fully recovery

Interpretation: BT and BP both significantly reduced incontinence episodes compared with control. But between BT and BP, there was no significant difference. Sample time, months

Effect size P-values

1 11.3% (17) 0.006

3 44% (66) <0.00001

6 31.4%(47) <0.00001

12 10.7% n.s.

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Appendix 6 - Table of Evidence (5):

Study type E

vide

nce

leve

l

No.

of

pa

tient

s Patient

characteristics Intervention Control

Length of

follow up

Outcome measures

Effect size

Burgio, K.L., Goode, P.S., Urban, D.A., Umlauf, M.G., Kicher, J.L., Bueschen, A. & Redden, D.T. (2006). Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: A randomized controlled trial. Journal of Urology, 175, 196-201. RCT ++

125 1. American

2. Age 53-68 3. Post-prostate

ctomy

Single session PFMT with biofeedback (n=63)

Usual care (n=62)

i.e. usual instruction by surgeon, not specifically PFMT

6 months

Primary: 1. Duration of

incontinence (mth)

Secondary:

2. QoL

1. Duration of incontinence

Interpretation: Duration of incontinence reduced by 3 months in treatment group Sample time, months

Effect size P-values

6 -3 0.04

(2) QoL Interpretation: No difference on quality of life between groups. 6 months No different n.s

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Appendix 7 - SIGN Checklist for RCT Studies (1) (Goode et al., 2011)

Section 1: Internal validity 1 The study addresses an appropriate

and clearly focused question Yes - Research question well covered.

2 The assignment of subjects to treatment groups is randomised

Yes - Good random assignment schedule generated by computer program written by the biostatistician (D.L.R.)

3 An adequate concealment method is used

Yes – Group assignments were placed in sealed envelopes and opened sequentially at the time of randomization

4 Subjects and investigators are kept ‘blind’ about treatment allocation

Yes – Participants blinding is not possible. Primary outcome measurement was scored by study staff that blinded to group assignment.

5 The treatment and control groups are similar at the start of the trial

Yes – Among all participants in three groups, there were no statistically significant differences. All P-values at baseline are >0.05.

6 The only difference between groups is the treatment under investigation

Yes – All groups kept daily bladder diaries and have clinical visit every 2 weeks for 2 months

7 All relevant outcomes are measured in a standard, valid and reliable way

Partly addressed – Primary outcome only scored by less reliable 7-day bladder diary for number of incontinence episodes. Other outcomes measurements are more reliable: EPIC and IIQ for condition specific quality of life. SF-36 for general quality of life. AUA-7 for UTI symptoms.

8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

Treatment group 1: PFMT – 17.1% Treatment group 2: PFMT plus biofeedback a– 22.9% (With reasonable explanation) Control: delay treatment – 5.9%

9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Yes - Primary outcome analysis used an intention-to-treat approach

10 Where the study is carried out at more than one site, results are comparable for all sites

Can’t say - Multi-site study but the specific data of sties characteristics is not mentioned.

11 How well was the study done to minimize bias? Code ++, +, or -

High quality (++) - majority of criteria met.

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Appendix 8 - SIGN Checklist for RCT Studies (2) (Tienforti et al., 2012)

Section 1: Internal validity 1 The study addresses an appropriate

and clearly focused question Yes - Research question well covered.

2 The assignment of subjects to treatment groups is randomised

Yes - Good random assignment schedule generated by computer, stratified with 1:1 allocation

3 An adequate concealment method is used

Partly addressed – concealment is mentioned but not described in details

4 Subjects and investigators are kept ‘blind’ about treatment allocation

Yes – Investigators, surgeons and nurses are blinded to the treatment allocation

5 The treatment and control groups are similar at the start of the trial

Yes – All baselines homogeneous. Age, disease stage, body mass, PSA level, all P-values at baseline are >0.05

6 The only difference between groups is the treatment under investigation

Yes – Both groups had the same clinical visits

7 All relevant outcomes are measured in a standard, valid and reliable way

Partly addressed – Primary outcome only scored by less reliable 7-day bladder diary for number of incontinence episodes (more objective). But QoL measurements are more reliable, with IPSS-QoL scale

8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

Treatment group (PFMT with biofeedback): 5.8% Control no pelvic floor muscle instruction/ written instructions : 5.8%

9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Partly addressed – one participant in intervention group were excluded from the analysis because he could not tolerate the procedure, this may have bias (but the percentage affected is very low)

10 Where the study is carried out at more than one site, results are comparable for all sites

No – Single center study

11 How well was the study done to minimize bias? Code ++, +, or -

Acceptable quality (+) - majority of criteria met.

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Appendix 9 - SIGN Checklist for RCT Studies (3) (Centemero et al., 2010)

Section 1: Internal validity 1 The study addresses an appropriate

and clearly focused question Yes - Research question well covered.

2 The assignment of subjects to treatment groups is randomised

Yes - Good random assignment schedule by permuted block randomization and computer generated list

3 An adequate concealment method is used

Yes – Sequentially numbered, sealed, opaque envelopes used

4 Subjects and investigators are kept ‘blind’ about treatment allocation

Yes – Patients not blinded to treatment, Investigators, surgeons and nurses are blinded to treatment

5 The treatment and control groups are similar at the start of the trial

Yes – All baselines homogeneous, i.e. MMSE, weight, urologic examination

6 The only difference between groups is the treatment under investigation

Yes – Both groups had the same clinical visits

7 All relevant outcomes are measured in a standard, valid and reliable way

Partly addressed – Primary outcome measured by bladder diary. QoL measurements are more reliable, with ICS male SF questionnaire scale

8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

Treatment group (PFMT pre & post-op): 0% Control (post-op only) : 0%

9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Yes – 59 patients in each group (treatment and control), 59 patients’ data are all analyzed

10 Where the study is carried out at more than one site, results are comparable for all sites

No – Single center study

11 How well was the study done to minimize bias? Code ++, +, or -

High quality (++) - majority of criteria met

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Appendix 10 - SIGN Checklist for RCT Studies (4) (Filocamo et al., 2010)

Section 1: Internal validity 1 The study addresses an appropriate

and clearly focused question Yes - Research question well covered.

2 The assignment of subjects to treatment groups is randomised

Can’t say – Randomization is mentioned but method not mentioned in detail

3 An adequate concealment method is used

No - Concealment method is not reported

4 Subjects and investigators are kept ‘blind’ about treatment allocation

Can’t say – Blinding is not clearly reported

5 The treatment and control groups are similar at the start of the trial

Yes – All baselines homogeneous, i.e. PSA level, catheterization periods

6 The only difference between groups is the treatment under investigation

Yes – Both groups had the same clinical visits

7 All relevant outcomes are measured in a standard, valid and reliable way

Yes – Primary outcome measured pad test. QoL measure by ICS male SF questionnaire scale

8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

Treatment group (PFMT): 0% Control (No PFMT) : 1.3%

9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Partly addressed– 2 patients in control group were not analyzed in 12-month time

10 Where the study is carried out at more than one site, results are comparable for all sites

No – Single center study

11 How well was the study done to minimize bias? Code ++, +, or -

Low quality (-) - randomization and allocation concealment are not clearly stated

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Appendix 11 - SIGN Checklist for RCT Studies (5) (Burgio et al., 2006)

Section 1: Internal validity 1 The study addresses an appropriate

and clearly focused question Yes - Research question well covered.

2 The assignment of subjects to treatment groups is randomised

Yes – Stratum randomization by computer generated list

3 An adequate concealment method is used

Yes – Centralized allocation used

4 Subjects and investigators are kept ‘blind’ about treatment allocation

Yes – Patients not blinded to treatment. Investigators, surgeons and nurses are blinded to treatment

5 The treatment and control groups are similar at the start of the trial

Yes – All baselines homogeneous, i.e. pathology reports, weight, urologic findings

6 The only difference between groups is the treatment under investigation

Yes – Both groups had the same clinical visits

7 All relevant outcomes are measured in a standard, valid and reliable way

Partly addressed – Primary outcome measured by bladder diary. QoL measurements are more reliable, with Medical Outcomes Study Short Form Health Survey

8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

Treatment group (PFMT with biofeedback): 9.5% Control (no PFMT) : 11.2%

9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Yes – Intention to treat 57 in treatment group and 55 in control group (6 patients in treatment and 7 in control were not analyzed because surgery was cancelled due to pre-operative health problem). Reasonable explanations were provided

10 Where the study is carried out at more than one site, results are comparable for all sites

Yes – Similar results in the site data reported

11 How well was the study done to minimize bias? Code ++, +, or -

High quality (++) - majority of criteria met

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Appendix 12 – Cost & benefit table

Tangible cost Tangible Benefit

- One-off training cost

$145 x 5 = $1225

(calculated based on physiotherapist

hourly rate at point 25)

- General expenses

i.e. Printing education materials

$1@ x 14 = $14 per patient

- Reduce cost for diagnosis, treatment,

incontinence care

- Reduce cost of doctor consultation /

SOPD burden for managing urinary

symptoms

- Reduce cost from complication of

urinary incontinence

- Reduce cost for surgical

management

- Reduce cost on incontinence

products, i.e. pads/ napkin

($320/month)

Intangible cost Intangible benefit

- Extra work of nurses

(an extra 20-30mins needed per

session; once pre-op and 6 sessions

post-op)

- Easily implement

- Low risk

- Reduce pain and suffering ; increase

QoL of patients

- Increase nurses’ moral

- Increase nurses’ autonomy and job

satisfaction on continence care

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Appendix 13 - SIGN grading system

Level of evidence

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low

risk of bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort or studies

High quality case control or cohort studies with a very low risk of confounding or bias

and a high probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of confounding or bias

and a moderate probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a significant

risk that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

Grades of recommendations

A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly

applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable

to the target population, and demonstrating overall consistency of results

B A body of evidence including studies rated as 2++, directly applicable to the target

population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+, directly applicable to the target

population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

87 | P a g e

Appendix 14 – Timeframe for communication & evaluation plan

Communication & Evaluation Plan of PFMT Program for

Prostatectomy Patients

Stakeholders Hospital Management: COS, GMN

WM, Urology consultant, MO

Steering Committee

Frontline nurses, Urology case manager, NS, APNs

Sept

- Dec

20

16

Consultation period: Collect

feedback & advices

Work plan meetings

Consultation period: Collect

feedback & advices

Jan

2017

Streamline

protocol

Seek approval for protocol

Project plan presentation

Project team

meeting Ward meeting

Feb

2017

PFMT training to nurses

Project team meeting for sharing and discussion

Mar

- Ju

n 20

17

Pilot run

Project team meeting for optimizing protocol

Jul 2

017

– A

pril

2018

Formative Evaluation

Clinical Trial

Summative Evaluation

May

20

18

Project team meeting – evaluation

Result presentation

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Appendix 15 - Satisfactory survey of patients

Program Evaluation Form (Patients’ version)

Pelvic floor exercise training program for post-prostatectomy patients

Please “” the appropriate rating of the following aspects of this program:

Description Strongly

Disagree Disagree Neutral Agree

Strongly

Agree

1 2 3 4 5

1. Pelvic floor muscles exercise (PFMT) program is useful to reduce the severity of urinary incontinence after prostatectomy

2. The exercise is easy to learn and follow

3. Perform PFMT at home is practicable for me

4.The duration of supervised session is appropriate

5.The treatment room is an appropriate place to conduct the intervention

6. You are satisfied with the new intervention as a whole

7. My feeling/ comment/ suggestion:

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

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Appendix 16 – Satisfactory survey of nurses

Program Evaluation Form (Nurses’ version)

Pelvic floor exercise training program for post-prostatectomy patients

Please “” the appropriate rating of the following aspects of this program:

Description Strongly

Disagree Disagree Neutral Agree

Strongly

Agree

1 2 3 4 5

1. Pelvic floor muscles exercise of beneficial to post-prostatectomy patients

2. The program is practical in the workplace

3. The trainings on PFMT is adequate

4. The venue for the program is appropriate

5. It is worth to continue this program in urology ward in long run

6. You are satisfied with the new protocol as a whole

7. My feeling/ comment/ suggestion:

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________