Female Urinary Incontinence

Female Urinary Incontinence Molly Heublein, MD Assistant Professor Clinical Medicine UCSF Women s Health Primary Care Disclosures I have nothing to disclose. Objectives Which is most true? Review the problem Feel confident with office diagnosis of urge versus stress incontinence Feel confident with first line treatments Be aware of new developments/options for referral A. I have diagnosed and treated less than 5 patients with incontinence B. I regularly diagnose and treat patients with incontinence but I feel unsure about my practice C. I diagnose and treat regularly and feel confident with my practice I h a v e d i a g n o s e d a n d t r... 32% I r e g u l a r l y d i a g n o s e a n d... 52% I d i a g n o s e a n d t r e a t r e g u... 16% 1

Female Urinary Incontinence If we don t ask, they won t tell An estimated 20 million American women struggle with urinary incontinence- around 50% of middle aged women, and 75% over the age of 75 1 Projected costs for urge incontinence alone: $76.2 billion in 2015 in the US 2 It leads to lower quality of life scores Urge incontinence increases risks for fractures and falls 3 It really is a primary care problem! Do you have any bothersome leakage of urine? Asking about bothersome symptoms increases treatment rates 15% in the elderly 1 Female Urinary Incontinence Female Urinary Incontinence Transient Chronic Urge Stress Mixed Overflow Functional Transient Chronic Urge Stress Mixed Overflow Functional 2

Urge Incontinence/Overactive Bladder (UI/OAB) Stress Incontinence (SUI) Detrusor muscle contracts more frequently/ at lower stimulatory threshold and leakage occurs Women feel the urge to urinate, but lack control to hold it until the ideal time. Frequency and nocturia can occur Sphincter/pelvic floor weakness gets overwhelmed by increased abdominal pressure and leakage occurs Symptoms occur with cough, sneeze, laugh, exercise, or change in position. Picture from NIDDK: http://kidney.niddk.nih.gov/kudiseases/pubs/uiwomen/index.aspx accessed 5/2015 Mixed Incontinence The basics. Both stress + urge Focus on treating the more bothersome symptoms Jan is a 66 year old overweight female with hyperlipidemia and low back pain who complains of urinary leakage for several years, recently worsening. She leaks a few times per day and wears pads most of the time. She s pretty bothered by her symptoms and wants to know what can be done to help. 3

Female Urinary Incontinence Transient Chronic Urge Stress Mixed Overflow Functional Jan reports that she usually leaks when she laughs or coughs. She has cut back on aerobic exercise because jogging makes her leak too. She gets up to urinate once per night, and in the day, goes every 2 hours. Question: What is the next best step? Feel confident in your office diagnosis! A. Refer Jan for post void residuals and urodynamic testing to evaluate the cause of her incontinence B. Diagnose her with urge incontinence C. Diagnose her with stress incontinence D. Order an MRI of her back to make sure her back pain and urinary incontinence is not cauda equina syndrome R e f e r J a n f o r p o s t v o i d r e... 15% D i a g n o s e h e r w i t h u r g e i... 6% D i a g n o s e h e r w i t h s t r e s s... 79% O r d e r a n M R I o f h e r b a c k.. 0% Basic questions have fair to good sensitivity and specificity in differentiating causes of incontinence 9 Post void residual are not needed 7 Neurologic testing adds little in a relatively healthy outpatient without known neurologic disease Urodynamic testing does not improve outcomes for conservative treatments (and it is controversial for surgical options) 8 4

The Sensitivity and Specificity of a Simple Test To Distinguish between Urge and Stress Urinary Incontinence 9 Sensitivity (95% CI) Specificity (95% CI) + Likelyhood ratio (95% CI) Neg Likelyhood ratio (95% CI) UI 0.75 (0.68-0.81) 0.77 (0.69-0.84) 3.29 (2.39-4.51) 0.32 (0.24-0.43) SI 0.86 (0.79-0.90) 0.60 (0.51-0.68) 2.13 (1.71-2.66) 0.24 (0.16-0.35) Free copy available at: http://coe.ucsf.edu/wcc/3questions.pdf Audience Question: Jan is diagnosed with stress incontinence, and treatment is initiated. The most effective initial treatment based on high quality evidence to suggest for her is: A. A. Tolterodine (Detrol) once daily B. B. Mirabegron (Mybetriq) once daily C. C. Pelvic floor muscle training D. D. Intravesicular OnabotulinumtoxinA (Botox) injections A. T o l t e r o d i n e ( D e t r o l ) o... 5% B. M i r a b e g r o n ( M y b e t r i q... 2% C. P e l v i c f l o o r m u s c l e t r a i... 93% D. I n t r a v e s i c u l a r O n a b o t... 0% 5

Pelvic Floor Muscle Training Lifestyle modifications Stress, urge and mixed all show >50% reduction in incontinence episodes compared to no treatment, number needed to treat 3 (NNT 6 for full continence) 1 Give a Kegels Prescription or refer to pelvic physical therapy. Handout available at: http://campuslifeservices.ucsf.edu/dmx/patiented/sdob G0030.pdf - Fluid management - Consideration of dietary factors - Timed voids - weight loss and exercise reduce incontinence episodes in obese women (NNT 4) 1 - Bladder diaries alone can improve symptoms significantly Pharmacologic Options: Stress No FDA approved treatments - off label duloxetine showed trend toward improvement - off label vaginal estrogens show trend toward improvement But neither has proven statistical significance Image from NIDDK: http://kidney.niddk.nih.gov/kudiseases/pubs/diary/pages/page1.aspx (accessed 5/2015) 6

Pharmacologic Options: Urge Pharmacologic Options: Urge Isabel is a healthy 70 year old woman. She had struggled with daily urge incontinence. She complains that she gets little warning before she gets a strong feeling of needing to pee, and sometimes can t make it to the bathroom. Regular kegels, fluid management, and timed voids helped reduce her leakage to about 5 episodes/day. She is still bothered enough to want to try more 68% treatment. What is the next best choice for therapy? A. Darifenacin (enablex) B. Mirabegron (Mybetriq) C. Oxybutynin transdermal patch D. Any of the above 0% 0% 32% Anticholinergics Beta-3 adrenergic agonists D a r i f e n a c i n ( e n a b l e x ) M i r a b e g r o n ( M y b e t r i q ) O x y b u t y n i n t r a n s d e r m a l... A n y o f t h e a b o v e Anticholinergics Anticholinergics Side effects can be limiting Limited effectiveness- all seem to have similar effects, NNT 7-9 for improvement in UI NNH with side effects 7-12 7 darifenacin (Enablex) ($290 branded only) fesoterodine (Toviaz) ($250 branded only) oxybutynin (Ditropan) XL ($210 branded, $100 generic) solifenacin (Vesicare) ($290 branded only) tolterodine (Detrol) ($240/mo generic, $320/mo branded) trospium (Sanctura) ($200/mo branded only) Approximate monthly costs (data from uptodate.com 5/2015) 7

Effects of Fesoterodine in Vulnerable Elderly Subjects De Beau, et al. Journal of Urology 2014 Anticholinergics Continuation rates are only 12-40% at 1 year and 6-12% at 2 years across all drugs 10 Mirabegron (Mybetriq) Next line therapies urge: Novel class of treatment NNT 12 More favorable side effect profile Safe to combine with anticholinergics Cost is about $300/mo Jan has tried long acting oxybutynin but experienced excessive dry mouth. She tried tolterodine but did not experience significant benefit in her symptoms. How should we next best help her: 56% A. Recommend the best brand of incontinence supplies B. Refer her for percutaneous tibial nerve stimulation C. Refer her for incontinence surgery D. Refer her for pessary fitting R e c o m m e n d t h e b e s t b r a.. 6% R e f e r h e r f o r p e r c u t a n e o.. R e f e r h e r f o r i n c o n t i n e n c... 23% 15% R e f e r h e r f o r p e s s a r y f i t t i n g 8

Next line therapies: UI Percutaneous Tibial Nerve Stimulation Neuromodulation: Percutaneous Tibial Nerve Stimulators Sacral Nerve Stimulator OnabotuliniumtoxinA injections Surgery is generally NOT an option for urge incontinence Picture from: Uroplasty Device Manufacturer https://www.uroplasty.com/patients/urgentpc SUmiT Trial Peters et al. Journal of Urology 2010 SUmiT Results 11 Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms 9

STEP trial STEP Trial 50 participants who benefited from the active arm of SUmiT Prospective monitoring Tapered protocol to approximately once monthly PTNS over 3 years 12 Sacral Nerve Stimulators Results of Sacral Neuromodulation Therapy for Urinary Voiding Dysfunction: Outcomes of a Prospective, Worldwide Clinical Study Picture from webmd: http://www.webmd.com/urinary-incontinence-oab/ss/slideshow-overactive-bladder 10

OnabotulinumtoxinA Image from urology patient information: http://www.camurology.org.uk/incontinence-treatment/ (accessed 5/2015) 11

Next line options for Stress Incontinence Uretheral Bulking Agents Urethral Bulking Agents Pessary Surgery Image from EAU Patient Information: http://patients.uroweb.org/ui/surgery-for-women-with-sui/bulking-agents/ accessed 5/2015 Pessary for SUI Surgical Options for SUI Surgical referral should be offered for fit patients with bothersome stress incontinence Cure rates of around 90% at 1 year Even in the elderly, cure rates of 55% at 5 years 15 Picture from Mayo Clinic: http://www.mayoclinic.org/dise ases-conditions/urinaryincontinence/multimedia/pessary -use/img-20006056 (accessed 5/2015) 12

Image from Cleveland Clinic: http://my.clevelandclinic.org/services/ob-gyn-womens-health/diseases-conditions/urinaryincontinence (accessed 5/2015) Image from the Mayo Clinic: http://www.mayoclinic.org/bladder-necksuspension/img-20007033 (accessed 6/2015) Long-Term Outcomes after Stress UI Surgery Funk, et al. Obstetrics and Gynecology, 2012. 13

In Summary Questions? Urge and stress incontinence are easily differentiated in the office with simple questions First line therapy for both is pelvic floor muscle strengthening and lifestyle measures Pharmacologic options, PTNS, sacral nerve stimulators, or botox are options for UI treatment Consider bulking agents, pessary, or surgical referral for SUI References References (cont) 1. Qaseem et al. Nonsurgical Management of Urinary Incontinence in Women: A clinical Practice Guideline from the Amercian College of Physicians. Ann Internal Med. 2014; 161:429-444. 2. Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Economic Burden of Urgency Urinary Incontinence in the United States: A Systematic Review. J Manag Care Pharm. 2014 Feb;20(2):130-40. 3. Brown et al. Urinary incontinence: does it increase risk for falls and fractures? Study of Osteoporotic Fractures Research Group. J Am Geriatr Soc. 2000 Jul;48(7):721-5. 4. Khandelwal et al. Diagnosis of Urinary Incontinence. Am Fam Physician. 2013 Apr 15;87(8):543-550. 8. Malone-Lee et al. Urodynamic verification of an overactive bladder is not a prerequisite for antimuscarinic treatment response. BJU Int. 2003 Sep;92(4):415-7. 9. Brown JS, Bradley CS, Subak LL, et al. The sensitivity and specificity of a simple test to distinguish between urge and stress urinary incontinence. Ann Intern Med 2006;144:715 23. 3IQ questionaire, UCSF patient handouts: http://coe.ucsf.edu/wcc/3questions.pdf (accessed 6/2015) 10. Veenboer, et al. Long-Term Adherance to Antimuscarinic Therapy in Everyday Practice: A Systematic Review. Journal of Urology. Vol 191, 1003-1008, April 2014. 11. Peters et al. Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results from the SUmiT trial. Journal of Urology. 2010 April: 183 (4): 1438-43. 5. Shamliyan et al. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. Comparative Effectiveness Reviews, No. 36. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Apr. Report No.: 11(12)-EHC074-EF 6. Huang AJ et al. Clinical Significance of Postvoid Residual Volume in Older Ambulatory Women. J Am Geriatr Soc. 2011 Aug;59(8):1452-8. doi: 10.1111/j.1532-5415.2011.03511.x. Epub 2011 Aug 1. 7. Shamliyan et al. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness Comparative Effectiveness Reviews, No. 36 Minnesota Evidence-based Practice Center Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Apr. Report No.: 11(12)-EHC074-EF 12. Peters KML, et al. Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study. J Urol. 2013 Jun;189(6):2194-201. doi: 10.1016/j.juro.2012.11.175. Epub 2012 Dec 3. 13. VanKerrebroeck et al. Results of Sacral Neuromodulation Therapy for Urinary Voiding Dysfunction: Outcomes of a Prospective, Worldwide Clinical Study. Journal of Urology. 2007 November. V17(5): 2029-34. 14. Chapple et al. OnabotulinumtoxinA 100 U Significantly Improves All Idiopathic Overactive Bladder Symptoms and Quality of Life in Patients with Overactive Bladder and Urinary Incontinence: A Randomised, Double-Blind, Placebo-Controlled Trial. European Urology. 2013 August; V64(2):249-256. 15. Hellberg D, Holmgren C, Lanner L, Nilsson S. The very obese woman and the very old woman: tension-free vaginal tape for the treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18:423 429 14