Kevin E Miller, MDFemale Pelvic Medicine and Reconstructive Surgery

March 4, 2020

Name the major categories of urinary incontinence in women

Understand the basic evaluation of urinary incontinence

Review history of stress incontinence procedures

Know the surgical and non-surgical treatments for stress incontinence

Stress incontinence

Urgency incontinence (overactive bladder)

Mixed incontinence

Overflow incontinence

Bypass of anatomic continence mechanism

Functional / Transient incontinence (DIAPPERS)

Involuntary urine loss associated with an over distended bladder caused by chronic urinary retention secondary to either:

Bladder outlet obstruction(mechanical)

Impaired detrusor contractility (bladder atony)

Impaired sensation(neurologic-autonomic or peripheral neuropathy)

Drugs-anticholinergics, Ca++ channel blockers, α, βagonists, radiation fibrosis

Fistula Vesicovaginal Urethrovaginal Vesicouterine

Diverticulum- urethral Mesh complications Ectopic ureters

Urethra Vagina Cervix/uterus

Epispadias (incomplete midline fusion of genitals)

(less common and characterized by “continuous leakage”)

Neurogenic Urge Incontinence

Associated with known neurologic disease

Detrusor hyperreflexia- old terminology

Idiopathic Urge Incontinence

Most common type - 90%

No specific cause found

Delirium/Dementia (prompted voiding)

Infection (topical estrogen)

Atrophy (topical estrogen)

Pharmacology (psychotropics)

Psychological (OCD, severe depression)

Endocrine ( glucose control, polydipsia)

Restricted mobility (bedside commode)

Stool impaction (colon laxatives, enemas)

Involuntary loss of urine with increases in intra-abdominal pressure (cough, strain, lifting, running)

Dx made when urine loss from urethra seen with valsalva= Stress Test

Two types of SUI Hypermobility of urethrovesicle junction

Intrinsic Sphincteric Deficiency (ISD)= impaired urethral function-intrinsically low pressure urethra

Inability of urethra to occlude

Causes: trauma, aging, atrophy, neuromuscular changes

May occur without increases in intra-abdominal pressures

MUCP < 20 cm H2O; VLPP <50 cm H2O

Elderly, fixed urethra, prior procedures

1. H+P

2. URINALYSIS (UA)

3. POST VOID RESIDUAL VOLUME (PVRV)

Physical exam

Stress test (supine, sitting, standing)

Urethral hypermobility - Q tip test , Bonney-Marshall test.

Neurologic exam (LE strength, sensation, DTRs, clitoral anal wink reflex, Babinski)

Inspection for atrophy, effect or prior surgery and palpation for masses, diverticulum, etc.

BMI

UA

Negative predictive value – 97% ( neg dipstick reliably rules out infection)

Culture if positive or suspicious

Post-void residual volume

Normal <100 ml Abnormal >200 ml

Measured by straight cath or bladder scan U/S immediately after void

Observe: ambulation, gait, spine deformity, joint immobility / limitations, general coordination, tremors, frailness, obesity, etc……

Assess Post void residual volume (PVRV) –Expert opinion

May perform multi-channel UDS in patients with stress incontinence (Grade C)- to confirm or refute dx, not to predict outcome

Should assess urethral function

If prolapse- perform stress testing with prolapse reduction

Strain angle/Q tip test for urethral hypermobility

> 30◦

3 Day Voiding Diary (Bladder diary)

Voiding diary

voided volumes (250 ml/ void)

intake volume (1,500 ml/day)

frequency (6 X / day)

nocturia (1-3X)

# incontinence episodes / day

NO

For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamictesting for outcomes at 1 year.

N Engl J Med. 2012 May 24;366(21):1987-97. doi: 10.1056/NEJMoa1113595. Epub 2012 May 2.A randomized trial of urodynamic testing before stress-incontinence surgery.Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, Amundsen C, Sirls LT, Norton PA, Arisco AM, Chai TC, Zimmern P, Barber MD, DandreoKJ, Menefee SA, Kenton K, Lowder J, Richter HE, Khandwala S, Nygaard I, Kraus SR, Johnson HW, Lemack GE, Mihova M, Albo ME, Mueller E, SutkinG, Wilson TS, Hsu Y, Rozanski TA, Rickey LM, Rahn D, Tennstedt S, KusekJW, Gormley EA; Urinary Incontinence Treatment Network

Mixed incontinence Severe POP beyond hymen Elevated PVR volume Urge incontinence-refractory to

conservation Rx Failed previous surgery for

incontinence Suspicion of ISD (fixed urethra,

+EBST) Voiding dysfunction Continuous incontinence/Severe

incontinence Neurologic disorders Decreased bladder capacity Bladder pain syndrome with urge

frequency refractory to Rx History of pelvic radiation Nocturnal enuresis refractory to

therapy

STRESS INCONTINENCE

URGENCY INCONTINENCE

Pelvic floor muscle therapy / E Stim

Vaginal devices

Bladder training

Weight loss

Smoking cessation

• Anti-muscarinic therapy

• Behavioral therapy• Timed voiding

• Urge suppression

• Physical therapy

Advocated as first line therapy

MUS (n=230) v. PFMT (n=230) RCT crossover Netherlands

Outcome measure= subjective cure one year follow up

53% in PFMT group 85%in MUS group

50% women cross over to MUS

Labrie, et al NEJM 2013

Requires willing, motivated patient

Is helpful therapy in 25 – 30%

Requires ongoing maintenance

May be preferred by younger women with milder SUI

1. H+P, UA, pelvic PT referral

2. H+P, UA, multichannel urodynamic evaluation, stress test

3. H+P, UA, qtip test, levator ani m. evaluation

4. H+P, UA, stress test, urethral assessment, post void residual vol.

5. H+P, UA, stress test (if positive, schedule TVT)

1. Slings

synthetic midurethral sling (retropubic, transobturator, mini slings)

Pubovaginal (bladder neck) sling (autologous, allo/xeno)

2. Retropubic urethropexy /colposuspension(Marshall, Marchetti, Krantz , Burch)

3. Urethral bulking agents (Collagen, Coaptite™, Silicone/Macroplastique™ )

Anterior Repair (colporrhaphy)

Trans-vaginal needle suspension procedures (Raz, Stamey, Gittes, etc)

Para-vaginal defect repair

Kermit Krantz 1923-2007

Ulf Ulmsten-Sweden

How does it work?

Elevation of anterior vaginal wall at the urethrovesical junction. Partially obstructive.

Elevate the proximal urethra to an “intraabdominal” position.

Permanent suture 2-3 per side Double purchase into full thickness of muscularis of anterior vaginal wall

(pubocervical fascia) MMK-attach to cartilaginous periosteum of median raphe Burch- attach to Cooper’s ligament Tanagho modification 1976 Routine obliteration of cul de sac recommended to reduce enterocele formation

7.6% (Burch 1967)- unconfirmed if this reduces recurrent prolapse

Location= at “bladder neck” = UVJ Graft is either fascia lata or rectus fascia Allografts and xenografts less effective More morbidity (pain, blood loss, retention, infection,

cath) than Burch or Synthetic MUS Redo operations – prior mesh complications

Is not a tape, more like surgical Velcro becoming surgical rebar-

Type I macroporousmesh- Tissue incorporation.

Sub middle third of urethra (high pressure zone) – “hammock” DOES NOT LIFT

Passive sling- increases urethral pressure with valsalva

1995 “Integral Theory” Ulmsten combination of PULs, PCM, and posterior levator plate work in concert to prevent stress incontinence. ????

Lower risk of bladder, nerve, vascular, and intra-abdominal viscera injury with trocar passage

Trocar passage through retro-pubic space

Gynecare TVT™Retropubic passage bottom to topPrototype device in Europe and US

Bladder puncture (3-10%) (22% + first 50 cases)**** Minor vascular injury- hematoma (>2%) Major vascular injury-life threatening hemorrhage (>0.7%***?) Major nerve injury (obturator n. 0.1%) Graft erosion (1-5%) Bowel puncture (see MAUDE database) Obstructed voiding (<5%)(20%) Short term reoperation 2.4% (sling revision, hematoma, bowel

perforation)* De novo detrusor overactivity (5-15%) Failure to cure (5-10%) UTI (10-17%)

Tamussino-2001*Austria Abouassaly-2004**Canada Kuuva-2002***Finland Lebret-2001**** France

TO MUS > RP MUS- overall 4.2% erosions in the post-op period 67% TO vs. 33% RP

Age

BMI

Current smoking

Menopausal status

Diabetes

Recurrent vaginal incision (take backs)

Previous POP or incontinence surgery

Kokanali, et al Eur J Obstet Gynecol Reprod Biol 2014

Retrospective cohort >95,000 women median follow up 5.5 years, mean age 51

RP (63%)or TO MUS (37%)

Rate of removal (partial or complete) 1.4% 1yr

2.7% 5 yr

3.3% 9 yr

Rate of reoperation 2.6% 1 yr

5.5% 5 yr

6.9% 9 yr

5% women undergo revision surgery within 10 years-Canada

Higher physician surgical volume is associated with decreased risk, with the decline occurring at a threshold of 50 cases annually

Concomitant prolapse repairs increased risk of revision

Surgeon specialty, hospital type, patient age not associated with outcome

From Muir, Tulikangas, Paraiso, & Walters: The relationship of tension-free vaginal tape insertion and the vascular anatomyObstet Gynecol 101:5 part1 p933-36 May 2003

BURCH / MMK “Gold Standard”- old

Direct vision More pain 20-30% de novo DO? Improves hyper-mobile

urethra (urethrocele)

Fewer complications Permanent suture-no erosions More obstructive- 100%

Catheter x7 days Rare serious injuries

More invasive? If open, LS is minimally

invasive (4 small incisions), but longer operation time, steep learning curve.

MUS “Gold Standard”-new

Blind needle passage Less pain Low de novo DO? Does not improve hyper-

mobile urethra or anterior wall prolapse

More complications Mesh erosions /perforations Voiding obstruction-20%

Foley cath 3 days ,LT ICSC 1% sling revision

Vascular/nerve injuries rare

Less invasive? 3 small incisions, less

operation time, shorter but caution learning curve

-72 women, 2 institutions, randomized to LS Burch v. TVT

-Operating time increased in LS Burch v. TVT-UDS at 1yr f/u increased SUI in LS Burch (18.8%) vs.

TVT (3.2%)At 1 and 2 yrs significant improvement in #

incontinence episodes per week in both groups (UDI, IIQ scores)

Conclusion: TVT results in greater objective and subjective cure rates for urodynamic stress incontinence

Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial. Paraiso, Walters, Karram, & Barber Obstet Gynecol 104(6):1249-58 Dec 2004

TVT has similar long-term efficacy to laparoscopic Burch for the treatment of SUI. A substantial proportion have some degree of incontinence 4-8 yrs after surgery, however the majority of incontinence is not bothersome.

Jelovsek, Barber, Karram, Walters, Paraiso 2008 BJOG

Insufficient evidence to support if one approach leads to better outcomes.

No difference in subjective failure between the two approaches

TO MUS decreased risk of bladder perforation Voiding dysfunction requiring take back 2.7% RP

vs. 0% TO Sung, et al AJOG 2007

Neuro symptoms 4% RP vs. 9.4% TO Richter, et al NEJM 2010

RP improved outcomes in pts. with ISD Scherlitz, et al Obstet Gynecol 2012

TO – long term higher repeat surgery

TO – in to out vs. out to in equal

RP bottom > top pass more effective than top >bottom

Ford, et alCochran Database Syst Rev 2017

RP superior to TO overall , especially in obese, recurrent SUI, ISD, and POP

Kim, et al J Urol 2019

Indications Elderly (intact cognition) ISD Short urethra Fixed urethra

Materials Collagen (Contigen)-

PROTOTYPE, NOW OFF MARKET

Calcium Hydroxylapatite(Coaptite)

Non-reactive Carbon particles-pyrolytic zirconium oxide beads (Durasphere)

Silicone (Macroplastique)

Cure -60-90% at 6-12mo, 50% at 2yr

Re-injections required 40% Irritative voiding 10-40% COMPLICATION- sterile

abscess

Your next intervention is:

A. Pelvic floor muscle therapy

B. trial of anti-muscarinics

C. Retropubic mesh MUS

D. multichannel cystometrogram

E. voiding diary

A. History- ascertain what her previous operation was

B. Urinalysis or urine culture

C. Post void residual volume

D. Physical exam- cough stress test and evaluate urethra

E. Multichannel urodynamic evaluation

F. Office screening cystoscopy

1. Repeat mesh sling –retropubic

2. pubovaginal sling- rectus fascia

3. urethral bulking injection

4. Laparoscopic Burch

5. Vaginal Estradiol cream