Suzette E. Sutherland, MD, MS, FPMRS Director, UW Medicine Pelvic Health Center Director, Female Urology Associate Professor.

Transcription

1 Female Urinary Incontinence: Diagnosis and Treatment Suzette E. Sutherland, MD, MS, FPMRS Director, UW Medicine Pelvic Health Center Director, Female Urology Associate Professor. Dept of Urology University of Washington School of Medicine

2 Not all incontinence is the same! Stress Incontinence anatomical weakness Urge Incontinence / OAB bladder function problem Overflow Incontinence incomplete bladder emptying Mixed

3 Types of Incontinence/Etiology Stress Urge Overflow Transient Weak pelvic floor muscle Multiple pregnancies Pelvic organ prolapse Damage to bladder nerves Spinal cord Bladder Ca Multiple sclerosis Parkinson s Alzheimer s Stroke BPH OAB Weak bladder muscles Diabetes Bladder tumors Urinary stones Delirium Infection Atrophic urethritis Pharmacologic Psychological Endocrine disorders Restricted mobility Stool impaction Steers WD, et al. In: Adult and Pediatric Urology. 4 th Ed. 2002: Available at: Accessed 2/1/06.

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5 Spectrum of UI SUI Mixed Symptoms Mixed Incontinence OAB Symptoms UUI SUI = stress urinary incontinence UUI = urge urinary incontinence Wein A, Rackley, R. J of Urol Suppl;175:S5-S10.

6 Medical Evaluation of Index Patient Medical history Characterize UI type Frequency/Severity Bother Factor Physical exam general/abd/pelvic/rectal Demonstration of SUI UHM or ISD Urine studies When indicated by sxs (IVS) UA dip, UA micro, UCx Post Void Residual Pad testing / Voiding diary Cystoscopy Urodynamics Upper tract imaging

7 Suggested Reasons for Referral Symptoms do not respond to initial medical treatment within 2 months New onset IVS -- persistent Hematuria without infection (>3 RBC/HPF) Recurrent UTI Incomplete bladder emptying (sx, PVR) Pain (pelvic, bladder, vaginal, urethral, perineal) Complicated neurologic or metabolic disease Failed previous incontinence surgery Radical pelvic surgery Pelvic prolapse

8 Treatment Options for Urinary Incontinence Depends on the type of incontinence. Stress vs Urge Many minimally invasive, easy, safe and effective options available today.

9 Stress Incontinence Treatment Options KEGELS / Pelvic Floor Muscle Exercises Biofeedback Medications: NONE Urethral bulking agents Burch, MMK, Bladder neck suspension: Abdominal surgeries Slings (mid-urethra): Vaginal surgeries Mesh Reiffenstuhl,Platzer & Knapstein

10 Stress Incontinence Treatment Options Pelvic Floor Muscle Exercises / Rehabilitation Kegels Biofeedback

11 Surgery for Stress Incontinence (Predominance of ISD) Urethral bulking agents Collagen Durasphere Macroplastique Coapitite

12 Surgery for Stress Incontinence Burch, MMK, Bladder neck suspensions/bladder neck slings: Abdominal surgeries Mid-urethral Slings: Vaginal surgeries Autograft Allograft Xenograft Mesh

13 Synthetic Mid-urethral Slings: TVT, SPARC, MONARC, TVT-O, MiniArc Mesh: Type I, monofilament, polypropylene Tension-free hammock Same-day min procedure Retropubic Transobturator Mini-Sling

14 Mid-urethral Sling Mesh Positions Monarc / TVT-O Mini-Slings TVT / SPARC Reiffenstuhl,Platzer & Knapstein

15 Sling results are excellent! full length midurethral slings, both retropubic and transobturator, have been extensively studied, are safe and effective relative to other treatment options and remain the leading treatment option and current gold standard of care for stress incontinence surgery. (AUGS 2013)

16 OAB / Urge Incontinence: Diagnosis & Treatments

17 AUA/SUFU OAB Treatment Guideline 1 st Line Behavioral therapies for all patients May be combined with antimuscarinics 2 nd Line Oral antimuscarinics Transdermal preparations Dose modification or switch to different antimuscarinic if inadequate efficacy or poor tolerability 3 agonist (mirabegron) 3 rd Line SNS PTNS Intradetrusor onabotulinum toxin A Gormley EA, et al. American Urological Association (AUA) Guideline. AUA Web site. Accessed August 6,

18 OAB / Urge Incontinence: Treatments Behavioral/Dietary Modification Lifestyle changes Biofeedback / Pelvic Floor Physiotherapy Medications Surgical Therapies:

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22 Medications Short-Acting Ditropan (oxybutynin) BID or TID Detrol (tolterodine) -- BID Sanctura (trospium chloride) -- BID Long-Acting Ditropan XL (oxybutynin ER) Oxytrol patch (oxybutynin ER) 2x/wk Gelnique (oxybutynin ER gel) Detrol LA (tolterodine LA) Toviaz (fesoterodine) Sanctura XR (trospium chloride XR) Vesicare (solifenacin) Enablex (darifenacin) Tofranil (imipramine) Myrbetriq (Mirabegron) beta 3 agonist

28 Medications Good initial trial is 2+ weeks. If noting some benefit, encourage continued trial to 4-6 weeks. Titrate up to max dose before changing agents. Trial of 2-3 agents is sufficient! Side effects may be limiting factor Address constipation! Reinforce behavioral modification

29 OAB / Urge Incontinence: Treatments Behavioral/Dietary Modification Lifestyle changes Biofeedback / Pelvic Floor Physiotherapy Medications Surgical Therapies: Neuromodulation InterStim, PTNS, Botox Augmentation Cystoplasty Urinary Diversion

30 3 rd Line OAB Therapies InterStim FDA Approved: 1997 Urgent PC FDA Cleared: 2005 BOTOX FDA Approved:

31 InterStim Therapy Sacral Nerve Stimulation (SNS): Pacemaker FDA approved 1997 Outpatient IV sedation / local Trial phase followed by implantation Efficacy 70-80% Durability at 5 years Indicated for Fecal Incontinence too!

32 Poor Candidates for InterStim Nerve damage Peripheral neuropathy Future need for MRI Pelvic malignancy Intrinsic abnormality of bladder XRT Fibrosis Decompensation Pain without voiding complaints Very elderly (>55; > 3 co-morbidities)

33 Urgent PC Therapy Percutaneous Tibial Nerve Stimulation (PTNS) FDA approved 2005 Clinic Sessions Treatment: 1/week X 12 weeks Maintenance: Q 3-4 weeks there after Efficacy 70-80% Durability to 3 years (so far) Comparable to Detrol LA 4mg QD

34 OrBIT Trial: Randomized trial of PTNS versus extended release tolterodine 100 OAB patients (94 females) 1:1 12-weeks PTNS vs. Tolterodine ER 4mg/day Objective improvement in voiding similar Subjective improvement greater in PTNS (78%) vs Tolterodine ER (55%). Both safe - Drug had greater dry mouth/constipation - PTNS had mild pain/bleeding/bruising at needle site No placebo, not blinded Peters, et al. J Urol 2009

35 SUmiT Trial: PTNS vs SHAM Randomized 220 pts 1:1 12-weeks PTNS vs SHAM GRA moderately/markedly improved As Follows: PTNS 58.3% vs SHAM 21.9% (p<0.001) ITT : PTNS 54.5% vs SHAM 20.9% (p<0.001) All objective voiding diary parameters noted statistically significant improvements with PTNS vs SHAM. Conclusion: Improvement with PTNS not just PLACEBO-effect Peters K. J Urol 2010; 183:

36 STEP Study 3-yrs: Long-term durability of PTNS for the treatment of OAB PTNS responders from SUmiT: 60/103 (58.3%) 50 entered extension trial 43/34/29 (58%) finished 12/24/36 months Treatment interval tapered to identify individual rates Average interval q 22.6 days Measures: voiding diary, global/safety assessments 29 pts at 36mo: 97% (28/29) were markedly/moderately improved in overall bladder symptoms on GRA All outcome measures significant over baseline Sustained therapeutic effect of PTNS for OAB patients over 3 years showed efficacy and durability Peters K. J Urol 2010; 183: Peters K. J Urol 2013; 189:

37 When to Use PTNS vs. InterStim Patient choice Mild-to-Moderate vs Moderate-to-Severe Introduction to neuromodulation Very young or elderly Neurogenic MRI compatibility Poor surgical candidates

38 FDA approved 2012 Outpatient cystoscopic procedure: office or ASC Local and/or IV sedation Risk of Retention (6%) Risk of UTI (13%) Temporary effect: Efficacy about 6 months per injection

39 ABC Trial: Anticholinergic vs Botox RCT, double-blinded over 6 months: Botox 100 Units + placebo med vs Solifenacin 5-10mg (TrospiumXR) + placebo injection No difference in change in mean number of UUI (mos 1, 2, 3, 4, 5, 6) 3.29 fewer UUI/day (Botox) vs 3.36 (Meds) Decreased from 5 UUI/day to 1.5 UUI/day Completely Dry: 27% Botox vs 13% Meds Side Effects Botox CIC (6%) and UTIs (13%) Meds Dry mouth and constipation Visco, et al. NEJM 2012

40 ROSETTA Trial: InterStim vs Botox 364 women -- RCT, over 6 months: Botox 200 Units vs InterStim Primary outcome Change in UUI episode/day - 3-day diaries Significantly greater mean reduction in UUI episodes/day in Botox group vs InterStim group at 6 months. Botox group more likely to: become completely dry report greater improvement in OAB bother sxs have higher satisfaction score endorse the treatment received Adverse Events Botox CIC 8% at 1 month, 2% at 6 months; and UTIs 35% InterStim UTI 11%; Surgical revision/removal 3% AUA Late-Breaking Abstract May 2017

41 InterStim vs. Botox I use both in my own practice The therapies are not equivalent What is the target? Botox is an end-organ (bladder) therapy SNM is a pelvic-oriented therapy Certain clinical situations are better suited for one versus the other

42 When to Use Botox vs InterStim Neurogenic Patients Progressive MRI compatibility Elderly Patient willing to perform ISC No coexisting bowel complaints Failed SNM Patient choice

43 Take Home Messages Urinary incontinence and OAB are common problems Many different types of treatment are available today, non-surgical and surgical: PFM Rehab / PT Medications Slings Neuromodulation: InterStim, PTNS, Botox The type of incontinence determines the appropriate treatment. Modern treatment procedures: Minimally invasive Outpatient, same-day surgery Safe Effective

44 QUESTIONS?????