Urinary Incontinence Evaluation and Nonsurgical Treatment WVU WOMENS

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Urinary Incontinence: Evaluation and Nonsurgical Treatment WVU WOMENS HEALTH CURRICULUM Stanley Zaslau, MD, MBA,

Urinary Incontinence: Evaluation and Nonsurgical Treatment WVU WOMENS HEALTH CURRICULUM Stanley Zaslau, MD, MBA, FACS Program Director & Associate Professor Division of Urology West Virginia University

Introduction and Terminology • Urinary incontinence: involuntary urine loss • 2 causes: urethral and

Introduction and Terminology • Urinary incontinence: involuntary urine loss • 2 causes: urethral and extraurethral

Introduction and Terminology • Urethral • Bladder – Detrusor overactivity (instability or hypereflexia) –

Introduction and Terminology • Urethral • Bladder – Detrusor overactivity (instability or hypereflexia) – Low bladder compliance – Urinary fistula • Sphincter – Urethral hypermobility – Intrinsic sphincter deficiency • Extraurethral • Urinary fistula • Sphincter abnormalities

Signs, symptoms and conditions causing incontinence • • Urge incontinence Stress incontinence Unaware incontinence

Signs, symptoms and conditions causing incontinence • • Urge incontinence Stress incontinence Unaware incontinence Continuous leakage Nocturnal enuresis Post void dribble Extra-urethral incontinence

Urge Incontinence • Condition: – Detrusor overactivity • Medical/surgical causes: – Idiopathic – Neurogenic

Urge Incontinence • Condition: – Detrusor overactivity • Medical/surgical causes: – Idiopathic – Neurogenic – Urinary tract infection – Bladder cancer – Bladder outlet obstruction

Stress Incontinence • Condition: – Urethral hypermobility – Intrinsic sphincter deficiency – Stress hyperreflexia

Stress Incontinence • Condition: – Urethral hypermobility – Intrinsic sphincter deficiency – Stress hyperreflexia (exercise) • Medical/surgical causes: – Pelvic floor relaxation – Prior surgery (urethra, bladder, pelvis) – Neurogenic

Unaware Incontinence • Condition: – Detrusor overactivity – Sphincter abnormality – Extraurethral incontinence •

Unaware Incontinence • Condition: – Detrusor overactivity – Sphincter abnormality – Extraurethral incontinence • Medical/surgical causes: – Idiopathic -- Neurogenic – Prior surgery – Vesico, uretero, urethral fistula – Ectopic ureter

Continuous Leakage • Condition: – Sphincter abnormality – Impaired detrusor contractility – Extraurethral incontinence

Continuous Leakage • Condition: – Sphincter abnormality – Impaired detrusor contractility – Extraurethral incontinence • Medical/surgical causes: – Neurogenic – Prior urethral, bladder or pelvic surgery – Ectopic ureter or urinary/vaginal fistula

Nocturnal Enuresis • Condition: – Sphincter abnormality – Detrusor overactivity • Medical/surgical cause: –

Nocturnal Enuresis • Condition: – Sphincter abnormality – Detrusor overactivity • Medical/surgical cause: – Idiopathic – Neurogenic – Outlet obstruction

Post-Void Dribble • Condition: – Post-sphincteric collection of urine • Medical/surgical causes: – Idiopathic

Post-Void Dribble • Condition: – Post-sphincteric collection of urine • Medical/surgical causes: – Idiopathic – Urethral diverticulum

Extra-Urethral Incontinence • Condition: – Vesico, uretero or urethrovaginal fistula – Ectopic ureter •

Extra-Urethral Incontinence • Condition: – Vesico, uretero or urethrovaginal fistula – Ectopic ureter • Medical/surgical cause: – Trauma -- Surgical – Obstetrical – Congenital – Other

Diagnostic Evaluation • • History of present illness Past medical history Physical examination Laboratory

Diagnostic Evaluation • • History of present illness Past medical history Physical examination Laboratory urodynamic evaluation

History of Present Illness • Patient’s symptoms – Frequency, urgency, dysuria, incontinence-type – Incontinence

History of Present Illness • Patient’s symptoms – Frequency, urgency, dysuria, incontinence-type – Incontinence with stress vs. urge – Difficulty with initiating stream? • Symptom severity – Wears pads? -- do they become saturated? – How often change pads?

Past Medical History • Neurologic conditions: – Multiple sclerosis – Spinal cord injury –

Past Medical History • Neurologic conditions: – Multiple sclerosis – Spinal cord injury – Parkinson’s disease • Surgical history – Prostate, vaginal surgery, prior repair for SUI? – APR, radical hysterectomy

Past Medical History • Radiation therapy? • Medications – Sympathomimetics – Tricyclic antidepressants –

Past Medical History • Radiation therapy? • Medications – Sympathomimetics – Tricyclic antidepressants – Parasympatheticomimetics

Physical Examination • Why? – Demonstrate incontinence – Detect prolapse and other pelvic conditions

Physical Examination • Why? – Demonstrate incontinence – Detect prolapse and other pelvic conditions • interstitial cystitis – Detect prostate conditions in men – Detect neurologic abnormalities

Physical Examination • Key points – Observe gait – Examine abdomen/flanks for masses –

Physical Examination • Key points – Observe gait – Examine abdomen/flanks for masses – Rectal examination (sphincter tone) – Perineal sensation – Bulbocavernosal reflex • absence in 30% of normal women

Physical Examination • Women: – Vaginal examination with empty and full bladder – Assess

Physical Examination • Women: – Vaginal examination with empty and full bladder – Assess urethral hypermobility (Q tip test) – Assess prolapse (cystocele, rectocele or enterocele) • “transverse groove” separates enterocele from rectocele – Assess vaginal mucosa – Assess incontinence (lithotomy vs. standing)

Urodynamic Evaluation • Why? – Determine etiology of incontinence – Evaluate detrusor function –

Urodynamic Evaluation • Why? – Determine etiology of incontinence – Evaluate detrusor function – Determine degree of pelvic floor prolapse

Urodynamic Evaluation • Why? – Indentify risk factors for upper tract deterioration • •

Urodynamic Evaluation • Why? – Indentify risk factors for upper tract deterioration • • detrusor external sphincter dyssynergia low compliance bladder outlet obstruction vesicoureteral reflux

Urodynamic Evaluation • When? – When simpler tests are inconclusive – When patient complains

Urodynamic Evaluation • When? – When simpler tests are inconclusive – When patient complains of incontinence and it can’t be demonstrated clinically – History of prior incontinence surgery – History of APR or radical hysterectomy – History of known neurologic disorder

Urodynamic Evaluation • Questions to ask before you start? – What symptoms do you

Urodynamic Evaluation • Questions to ask before you start? – What symptoms do you want to reproduce? – What is the functional bladder capacity? – Does the patient empty their bladder? – Is urinary incontinence a complaint? – Is there a neurologic lesion that can cause DESD, hyperreflexia or areflexia?

Cystometry • Graphic representation of intravesical pressure as a function of bladder volume •

Cystometry • Graphic representation of intravesical pressure as a function of bladder volume • Detrusor activity: – overactive – underactive – normal activity

Nonsurgical Treatment: Overview • Nonsurgical treatment of lower urinary tract dysfunction – Behavioral interventions

Nonsurgical Treatment: Overview • Nonsurgical treatment of lower urinary tract dysfunction – Behavioral interventions (Bladder training, habit training, timed voiding, prompted voiding) – Biofeedback therapy – Pelvic floor rehabilitation – Principles of pharmacologic therapy

Behavioral Interventions for Urinary Incontinence • • Bladder training Habit training Timed voiding Prompted

Behavioral Interventions for Urinary Incontinence • • Bladder training Habit training Timed voiding Prompted voiding

Bladder Training • Three primary components – Education • physiology & pathophysiology of incontinence

Bladder Training • Three primary components – Education • physiology & pathophysiology of incontinence – Scheduled voiding • gradual increase in time between voids • distraction/relaxation techniques – Positive reinforcement • praise: if increase time between voids

Bladder retraining • Systematic delay in voiding through use of urge suppression • Patient

Bladder retraining • Systematic delay in voiding through use of urge suppression • Patient must be able to identify urge, understand how to inhibit the urge and be motivated to do so! • Care can be independent or dependent on caregivers

Bladder retraining • Urge is suppressed using a pelvic muscle exercise (Kegel) • Time

Bladder retraining • Urge is suppressed using a pelvic muscle exercise (Kegel) • Time between voids is gradually increased in 15 minute increments, up to goal time of two to three hours between voids

Habit training • Must do a voiding diary first!! • Matches toileting assistance to

Habit training • Must do a voiding diary first!! • Matches toileting assistance to the patient’s pattern of voiding • Pre-empts the incontinence by toileting before the incontinent episode • No attempt to delay voiding or resist urge • Usually caregiver dependent

Timed Voiding • Set schedule for patient to toilet on a planned basis •

Timed Voiding • Set schedule for patient to toilet on a planned basis • Schedule is individualized to patient’s voiding schedule • Typically patient asked to void every 2 hours regardless of desire to void

Prompted voiding • Patient is encouraged and assisted to toilet every 2 hours from

Prompted voiding • Patient is encouraged and assisted to toilet every 2 hours from 7 am to 7 pm • Must be able to use a toileting device • Caregiver dependent • Prompts can be verbal reminders or physical assistance to the toilet • Adjust prompt times to meals and qhs

Clinical Uses of Scheduling Regimens • Bladder training – Functionally & mentally intact patients

Clinical Uses of Scheduling Regimens • Bladder training – Functionally & mentally intact patients • Habit retraining – Functionally & mentally intact patients • Timed voiding – Nursing home residents, patients with NGB • Prompted voiding – Patients with cognitive/mobility impairment

Conclusions about Behavioral Therapy • • • Can treat urinary incontinence (UI> SUI) Can

Conclusions about Behavioral Therapy • • • Can treat urinary incontinence (UI> SUI) Can treat sensory urgency Inexpensive Has no side effects Can be done in inpatient or outpatient setting No special equipment required

Biofeedback • Originated in laboratory research 25 years ago • Applied to urinary bladder

Biofeedback • Originated in laboratory research 25 years ago • Applied to urinary bladder • ? Mechanism of action: reflex inhibition? • Programs: voluntary contraction of pelvic muscles (pubococcygeous & levator) • Goal: modify visceral control (bladder)

Biofeedback • Relates to anatomy of pelvic muscles – identify pubococcygeous muscle – identify

Biofeedback • Relates to anatomy of pelvic muscles – identify pubococcygeous muscle – identify muscles of external and urethral sphincter • all muscles innervated by S 2 via pudendal nerve – voluntary contraction of EUS can interrupt incontinence during an episode of urgency and relax detrusor

Biofeedback • • • Bladder Filling Signal Source Equipment Patient Selection Results

Biofeedback • • • Bladder Filling Signal Source Equipment Patient Selection Results

Results for Biofeedback • Conclusions – Effective to reduce episodes of urge incontinence –

Results for Biofeedback • Conclusions – Effective to reduce episodes of urge incontinence – Less is known about: • Frequency: hallmark of bladder training • Urgency: difficult to measure • Nocturia: multi-factorial condition Borgio, JAGS 2000

Electrostimulation • Transvaginal or transanal • Effects: – cause passive contraction of pelvic floor

Electrostimulation • Transvaginal or transanal • Effects: – cause passive contraction of pelvic floor musculature • Potential uses: – “Re-educate” weak muscles to contract – Relieve symptoms of urge incontinence/pelvic pain

Electrostimulation • Home or office use • Protocol: – Bladder dysfunction: use low frequencies

Electrostimulation • Home or office use • Protocol: – Bladder dysfunction: use low frequencies – Detrusor instability: use higher frequencies • 10 or 12. 5 Hz – Stress incontinence: use higher frequencies • 50 or 100 Hx – Mixed incontinence: mid frequencies (20 Hz)

Electrostimulation • Conclusions – E-stim useful in patients with nonobstructive urinary retention – Addition

Electrostimulation • Conclusions – E-stim useful in patients with nonobstructive urinary retention – Addition of urecholine did not improve e-stim results – Subjective success rate stress urge incontinence: 71% – Subjective success rate detrusor instability: 70% – Subjective success rate mixed urge incontinence: 52% Bernier and Davila, 2000 Urol Nursing Bent, et al. 1993 Int J Urogynecol

E-stim and Biofeedback Combo? • Conclusions – Biofeedback and e-stim are effective to treat

E-stim and Biofeedback Combo? • Conclusions – Biofeedback and e-stim are effective to treat urinary incontinence – Reasonable initial steps in the management of urinary incontinence Aikey, et al Albany Med

Vaginal Weighted Cones • Inexpensive ($50 -200/set) • Procedure – cone inserted into vagina

Vaginal Weighted Cones • Inexpensive ($50 -200/set) • Procedure – cone inserted into vagina above levators – patient tightens muscles when cone slips down – sequential increase in cone weight/size

Vaginal Weighted Cones • Results – Six series of 189 patients – Satisfaction rates

Vaginal Weighted Cones • Results – Six series of 189 patients – Satisfaction rates of 40 -70% among those compliant with therapy – Cumulative drop out rate of 28% – Many will not accept this therapy – Some cannot even retain the lightest cone

Summary of Techniques • Review of 22 trials: – Pelvic floor muscle exercises treat

Summary of Techniques • Review of 22 trials: – Pelvic floor muscle exercises treat SUI – Biofeedback + PFM no better than PFM alone – No difference between e-stim and otherapies – Weak evidence to suggest bladder retaining is no more effective than drug therapy

Medical Therapy • Medications for Stress Incontinence – Alpha adrenergics – Estrogens • Medications

Medical Therapy • Medications for Stress Incontinence – Alpha adrenergics – Estrogens • Medications for Urge Incontinence – Tolterodine – Oxybutynin XL – Oxybutynin Transdermal

Medical Therapy- Alpha Agonists • Phenylpropanolamine(PPA) – best studied alpha agonist – taken off

Medical Therapy- Alpha Agonists • Phenylpropanolamine(PPA) – best studied alpha agonist – taken off market -- hemorrhagic strokes in young women – 5/8 studies with PPA demonstrated improvement in SUI by 19 - 60% vs. placebo – However, pseudoephedrine is available with similar efficacy

Medical Therapy - Alpha Agonists • Estrogens – controversial – receptors in urethra, vagina

Medical Therapy - Alpha Agonists • Estrogens – controversial – receptors in urethra, vagina --> tissue atrophy with menopause? – Metaanalysis of 8 trials “superior to control” – Contrary -- Grady, et al 2000 -- “worsening of incontinence vs. controls at 4 years) • problem -- in study only 26% had SUI

Medical Therapy – Overactive Bladder (OAB) • Oral oxybutynin – proven muscarinic activity of

Medical Therapy – Overactive Bladder (OAB) • Oral oxybutynin – proven muscarinic activity of active agent – efficacy similar with XL form – benefit of XL for side effects – dosing magnitude higher • improved tolerability

Medical Therapy - OAB • Oral oxybutynin – compliance benefit with once daily dosing

Medical Therapy - OAB • Oral oxybutynin – compliance benefit with once daily dosing – steady state pharmacokinetics • modulated serum peaks • less variance below threshold levels – lower discontinuance rates

Medical Therapy - OAB • Tolterodine tartrate – active anti-muscarinic compound – binding selectivity

Medical Therapy - OAB • Tolterodine tartrate – active anti-muscarinic compound – binding selectivity for bladder – improved xerostomia – generally well tolerated – extended release formulation -- good for xerostomia – ER form works as well as IR form

Medical Therapy - OAB • Transdermal oxybutynin – altered metabolism of parent • avoidance

Medical Therapy - OAB • Transdermal oxybutynin – altered metabolism of parent • avoidance of proximal gut CYP 450 – equal efficacy to IR formulation – substantially less systemic side effects – compliance benefit • twice weekly application

Medical Therapy - OAB • OPERA Trial (Diokno et al), Mayo Clin Proc –

Medical Therapy - OAB • OPERA Trial (Diokno et al), Mayo Clin Proc – Tol ER vs. Oxy ER – 12 week double-blind study – 790 women enrolled – Primary outcomes • urge incontinence • total incontinence • urinary frequency

Medical Therapy - OAB • OPERA – Similar effect between active arms • significant

Medical Therapy - OAB • OPERA – Similar effect between active arms • significant reduction for all outcomes – Statistical difference • urinary frequency (28% vs. 25%) • total continence (23% vs. 17%) – Adverse events • total dry mouth greater for OXY ER • discontinuation rates same

Medical Therapy - OAB • ACET, Sussman, et al 2002 – Open label direct

Medical Therapy - OAB • ACET, Sussman, et al 2002 – Open label direct comparison • OXY ER 5/10 • TOL ER 2/4 – 8 week analysis – 1289 patients – TOL ER 4 mg superior to all others (70% vs 60%) – Significantly less dry mouth with TOL ER – Discontinuation rates • 6% TOL ER vs. 13% OXY ER

Medical Therapy - OAB • OXY-TDS vs. TOL-LA vs. Placebo • (Domchowski, et al

Medical Therapy - OAB • OXY-TDS vs. TOL-LA vs. Placebo • (Domchowski, et al Urol 2003) – compare efficacy and safety of OXY-TDS vs. TOL LA vs. placebo – Multi-center, double blind, randomized trial for 12 weeks & then 52 week open label – 361 patients randomized • OXY-TDS 3. 9 mg/d or TOL LA 4 mg/d

Medical Therapy - OAB • Results Parameter OXY-TDS TOL-LA Placebo Complete continence Urinary freq

Medical Therapy - OAB • Results Parameter OXY-TDS TOL-LA Placebo Complete continence Urinary freq reduction Voided volume increase 40% 17% 15% 40% 17% 19% 24% 8% 3%

Medical Therapy - OAB • Adverse Effects Parameter OXY-TDS TOL-LA Placebo Dry mouth Constipation

Medical Therapy - OAB • Adverse Effects Parameter OXY-TDS TOL-LA Placebo Dry mouth Constipation Blurred vision Dizziness Application site issues Pruritis Erythema 4. 1% 3. 3% 2. 5% 0. 8% 7. 3% 5. 7% 0. 8% 2. 4% 1. 7% 0. 9% 14% 8. 3% 2. 4% 0. 8% 4. 3% 1. 7%

Parting Thoughts • Improvement is attainable in the majority of patients – with combined

Parting Thoughts • Improvement is attainable in the majority of patients – with combined behavioral therapies? • The ideal agent/non pharmacologic therapy is not yet available • Distinguishing criteria and outcomes – difficult to separate absolute results

References • • Aikey, et al, Albany Med. Bent et al. , Int J

References • • Aikey, et al, Albany Med. Bent et al. , Int J Urogynecol 1993. Bernier F and Davila GW, Urol Nurs 2000: 261 -4. Borgio KL, Locher JL, Goode PS. J Am Geriatr Soc 2000: 370 -4. Diokno AC et al, Mayo Clin Proc 2003 Jun; 78(6): 687 -95. Dmochowski RR, et al, Urology 2003 Aug; 62(2): 237 -42. Grady, et al, 2000. Sussman D, Garely A. Curr Med Res Opin. 2002; 18(4): 177 -84.