Wednesday, April 8, 2015 Anaheim, CA. Educational Partner:

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1 Wednesday, April 8, 2015 Anaheim, CA Educational Partner:

2 Session 4: Overactive Bladder: Individualized Management to Bridge the Quality Gap Learning Objectives 1. Understand the importance of participating in national quality initiatives and identify quality measure(s) that apply best to clinical settings and patients needs 2. Develop a patient-centered approach to the diagnosis of overactive bladder (OAB), proactively questioning patients at risk for bladder problems 3. Individualize the management of OAB patients utilizing guideline-and evidence-based approaches to provide optimal care, reduce risk of central and peripheral adverse events, and improve patient quality of life Faculty M. Ray Painter, MD, FACS President Physician Reimbursement Systems Denver, Colorado Dr M Ray Painter is a board certified urologist and cofounder and current president of Physician Reimbursement Systems, Inc. (PRS), a firm in Denver, Colorado, that assists physicians with complicated coding and payment concerns. Dr Painter is also the cofounder and president of PRS Urology Service Corporation, and previously established a solo urology practice in Grand Junction, Colorado, which grew into a four person practice under his guidance and leadership. Dr Painter has authored coding and reimbursement articles for Urology Times, Urology PracticeToday.com, and the Journal of Urology, among other publications. He lectures nationwide on these topics and on the future of the health care industry. A fellow of the American College of Surgeons, Dr Painter holds active memberships in numerous professional societies. Matt T. Rosenberg, MD Director Mid Michigan Health Centers Jackson, Michigan Dr Rosenberg earned his medical degree at the University of California, Irvine. He trained in general surgery at UC Irvine and in urologic surgery at Brigham and Women s Hospital, Boston, before changing fields to general practice. Dr Rosenberg now practices in Jackson, Michigan, and serves as medical director of Mid-Michigan Health Centers. He is on staff at Allegiance Health, Jackson, where he served as the chief of the department of family medicine from 2003 to Dr Rosenberg has a special interest in the medical management of urologic diseases. He has authored and coauthored articles appearing in International Journal of Clinical Practice, Journal of Urology, BJU International, Urology, and other peer reviewed journals. He is currently the section editor of urology for the International Journal of Clinical Practice and a reviewer for several other national and international journals. He has presented his original research at many national meetings, including those of the National Institutes of Health, American Urological Association, the Sexual Medicine Society of North America, and the European Society for Sexual Medicine. Session 4

3 Faculty Financial Disclosure Statements The presenting faculty reported the following: Dr M Ray Painter has nothing to disclose. Dr Matt Rosenberg serves on the speaker board of Astellas and is on the medical advisory boards of Astellas, Bayer, and Janssen. Education Partner Financial Disclosure Statement The content collaborators at Rockpointe have nothing to disclose. Suggested Reading List Rosenberg MT, Witt ES, Barkin J, miner M. A practical primary care approach to overactive bladder. Can J Urol. 2014;21 (Suppl 2):2-11. Rosenberg MT1, Staskin DR, Kaplan SA et al. A practical guide to the evaluation and treatment of male lower urinary tract symptoms in the primary care setting. Int J Clin Pract. 2007;61(9): Gormley EA, Lightner DJ, Faraday M, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment. J Urol Jan 23. Coyne KS, Sexton CC, Vats V, et al. National community prevalence of overactive bladder in the United States stratified by sex and age. Urology. 2011;77(5): Benner JS, Becker R, Fanning K, et al. Bother related to bladder control and health care seeking behavior in adults in the United States. J Urol. 2009;181(6): Soda T, Masui K, Okuno H, et al. Efficacy of nondrug lifestyle measures for the treatment of nocturia. J Urol. 2010;184(3): Abraham N, Goldman HB. An update on the pharmacotherapy for lower urinary tract dysfunction. Expert Opin Pharmacother. 2015;16(1): Chapple CR, Kaplan SA, Mitcheson D, et al. Mirabegron 50 mg once-daily for the treatment of symptoms of overactive bladder: an overview of efficacy and tolerability over 12 weeks and 1 year. Int J Urol. 2014;21(10): Castro-Diaz D, Chapple CR, Hakimi Z, et al. The effect of mirabegron on patient-related outcomes in patients with overactive bladder: the results of post hoc correlation and responder analyses using pooled data from three randomized Phase III trials. Qual Life Res Feb 17. [Epub ahead of print]. Han JY, Lee KS, Park WH, et al. A comparative study on the efficacy of solifenacin succinate in patients with urinary frequency with or without urgency. PLoS One. 2014;9(11):e Orri M, Lipset CH, Jacobs BP, Costello AJ, Cumming SR. Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE trial. Contemp Clin Trials. 2014;38(2): Session 4

4 12:30 1:45pm Overactive Bladder: Individualized Management to Reduce Adverse Events and Bridge the Quality Gap SPEAKERS Matt T. Rosenberg, MD M. Ray Painter, MD, FACS Presenter Disclosure Information The following relationships exist related to this presentation: M. Ray Painter, MD, FACS has nothing to disclose. Matt T. Rosenberg, MD serves on the speaker board of Astellas and is on the medical advisory boards of Astellas, Bayer, and Janssen. Off-Label/Investigational Discussion In accordance with pmicme policy, faculty have been asked to disclose discussion of unlabeled or unapproved use(s) of drugs or devices during the course of their presentations. Drug Listing The following drugs are discussed in this presentation: Darifenacin (Enablex) Fesoterodine (Toviaz) Mirabegron (Mybetriq) Oxybutynin ER (Ditropan XL) Oxybutynin TDS (Oxytrol) Oxybutynin 10% gel (Gelnique) Oxybutynin IR (Ditropan) Solifenacin (Vesicare) Tolterodine ER (Detrol LA) Tolterodine IR (Detrol) Trospium Chloride (Sanctura XR) Trospium Chloride (Sanctura) Faculty Speakers M. Ray Painter, MD, FACS President Physician Reimbursement Systems Denver, CO Matt T. Rosenberg, MD Director Mid Michigan Health Centers Jackson, MI Learning Objectives Understand the importance of participating in national quality initiatives and identify quality measure(s) that apply best to clinical settings and patients needs Develop a patient-centered approach to the diagnosis of OAB, proactively questioning patients at risk for bladder problems Individualize the management of OAB patients utilizing guideline- and evidence-based approaches to provide optimal care, reduce risk of central and peripheral adverse events, and improve patient quality of life Definition of OAB OAB is a syndrome or symptom complex defined as: Urgency, with or without urgency incontinence, usually with frequency and nocturia Urgency is the key symptom of OAB Urgency is defined as a sudden compelling desire to void, which is difficult to defer Abrams P et al. Urology. 2003;61: Rosenberg MT et al. Int J Clin Pract. 2007;61:

5 Definition of STRESS INCONTINENCE Prevalence of OAB Symptoms Stress urinary incontinence is the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing. Respondents (%) in 3 US adults 40 years of age reported symptoms of OAB at least sometimes Men Women 10 International Continence Society (ICS): Standardisation and Terminology Reports/Documents CURRENT. Available at: Abrams P et al. Neurourol Urodyn. 2002;21: Age (years) Coyne S et al. Urology. 2011;77: OAB and Other Disorders Chronic Bronchitis Diabetes Ulcer Asthma Hay Fever/Allergic Rhinitis Heart Disease Chronic Sinusitis Overactive Bladder Arthritic Symptoms Millions Stewart WF et al. World J Urol. 2003;20: Pleis JR, Coles R. Vital Health Stat ;209: Centers for Disease Control and Prevention/National Center for Health Statistics. Vital and Health Statistics. Hyattsville, MD: US Department of Health and Human Services; DHHS Publication No. (PHS) Available at: Risk Factors for OAB Increasing Age Diabetes Mellitus (30%-70%) Neurogenic (multiple sclerosis (50%-80%), Parkinson s disease, cerebrovascular disease, spinal cord injury Obesity Multiple pregnancies Surgery (prostate and pelvic surgeries) Ouslander JG. N Engl J Med. 2004;350: Parazzini F et al. BJOG. 2003;110: Stewart WF et al. World J Urol. 2003;20: OAB is Prevalent, Undiagnosed, and Undertreated 33.3 million US adults are said to have OAB Less than 50% will discuss with health care provider Only a minority will be diagnosed and offered treatment A smaller proportion will stay on therapy Barriers to OAB Care Patients Clinicians Stewart WF et al. World J Urol. 2003;20: Rovner E, Wein A. Curr Urol Rep. 2002;3: Milsom I et al. BJU Int. 2001;87: Benner J et al. J Urol. 2009;181; Rosenberg M et al. Cleve Clinic J Med. 2007;74;S21-S29. Goepel M et al. Eur Urol. 2002;41: Dmochowski RR et al. Curr Med Res Opin. 2007:23:65-76.

6 Patients Don t Discuss Bladder Issues with the Provider Embarrassment Fear of invasive procedures or need for surgery Perception of lack of available and effective treatment What Do Patients Say? I have had this problem and did not know who to talk to My previous doctor told me it was part of aging It became a problem only when my diaper overflowed I thought it was normal as my sister and mother had this You mean going to the bathroom every hour is not normal? I am too embarrassed Ricci JA et al. Clin Ther. 2001;23: Milsom I et al. BJU Int. 2001;87: MacDiarmid S, Rosenberg M. Curr Med Res Opin. 2005; 21; Coping Strategies Potential Misconceptions in OAB Use diapers or other absorbent products Carry extra clothes in case of wetting accident Wear dark, baggy clothes to hide wet spots or wear diapers To cope with symptoms of OAB, many patients employ elaborate behaviors aimed at hiding and managing urine loss Try to urinate on a schedule Bathroom mapping Restrict fluid intake OAB is a natural part of aging Diagnosis and treatment of genitourinary disease is to be determined by a specialist Diagnosis and treatment is outside the realm of the PCP setting Rosenberg MT. Curr Urol Rep ;9: Abrams P et al. Am J Manag Care Jul;6(11 Suppl):S580-S590. Ricci JA, et al. Clin Ther. 2001;23: MacDiarmid S, Rosenberg M. Curr Med Res Opin. 2005;21: What Do Doctors Say? Identifying OAB Takes a Village No time Treatments are not all that effective If it was a problem for the patient, he or she would bring it up Your bladder/penis/kidney won t kill you, your heart will, so I need to focus MacDiarmid S, Rosenberg M. Curr Med Res Opin. 2005;21: Rosenberg MT. Curr Urol Rep. 2008;9: Yu YF et al. Value Health. 2005;8:

7 The PCP Role in Partnership with the Urologist and the Urogynecologist Identification and initial evaluation of OAB starts in the office of the PCP There is a significant amount of medically related LUTS The diagnosis of OAB does not require an extensive or complicated evaluation Why Should We Care? Quality of life Quality measures Stewart WF et al. World J Urol. 2003;20: Darkov T et al. Pharmacotherapy. 2005;25: Ailinger RL et al. J Comm Health Nurs. 2005;22: Rosenberg M et al. Cleve Clinic J Med. 2007;74;S21-S29. The Top Ten The Top Ten Medical Conditions That Are Too Embarrassing for Patients to Discuss with Their Family Physicians 1. Impotence 2. STDs 3. Physical and Sexual Abuse 4. Prostate Problems 5. Incontinence of Bladder or Bowels 6. Emotional Problems like Depression 7. Eating Disorders 8. Alcohol or Drug Abuse 9. Birth Control and Sex (especially teens) 10. Menopause Preboth MA, Wright S. Am Fam Phys. 1999;59: Why Quality Measures? To improve the quality of care Feedback on performance for continuous improvement To understand the quality care Population-level surveillance To assess physician competence Maintenance of certification To reward physicians and practices that provide high-quality care Financial incentives Urinary Issues-related Quality Measures Measure Name Source Application % female patients aged 65 years old and older with a diagnosis of urinary incontinence with a documented plan of care for urinary incontinence at least once within 12 months % female patients aged 65 years old and older who were assessed for the presence or absence of urinary incontinence within 12 months AGS, PCPI, NCQA AGS, PCPI, NCQA Ambulatory/ Office-based Care Ambulatory/ Office-based Care Quality Strategy Aim Priority Prevention and Treatment of Leading Causes of Mortality Person- and Familycentered Care; Prevention and Treatment of Leading Causes of Mortality O Connor PJ et al. Diabetes Care. 2011;34: National Quality Measure Clearinghouse. Available at:

8 Urinary Issues-related Quality Measures Measure name Source Application % female patients aged 65 years old and older with a diagnosis of urinary incontinence who were prescribed a medication to treat the urinary incontinence who had a trial of behavioral therapy documented % Medicare members 65 years old and older who reported having urine leakage in the past six months and who reported that urine leakage made them change their daily activities or interfered with their sleep a lot Long-stay nursing home care: percent of lowrisk residents who lose control of their bowel or bladder AGS, PCPI, NCQA NCQA, HEDIS RTI International Ambulatory/ Office-based Care Managed Care Skilled Nursing Facilities/ Nursing Homes Quality strategy aim priority Prevention and Treatment of Leading Causes of Mortality Person- and Familycentered Care; Prevention and Treatment of Leading Causes of Mortality Clinicians Performance with Urinary Issues-related Measures Measure Urinary Incontinence: Assessment of Presence or Absence of Urinary Incontinence in Women Aged 65 Years and Older Urinary Incontinence: Characterization of Urinary Incontinence in Women Aged 65 Years and Older Urinary Incontinence: Plan of Care for Urinary Incontinence in Women Aged 65 Years and Older Eligible Professionals Eligible Professionals Who Reported Eligible Professionals Who Reported Satisfactorily 546,125 2, % 125,927 2, % 125,927 2, % National Quality Measure Clearinghouse. Available at: Centers for Medicare and Medicaid Services report experience including trends ( ). Physician Quality Reporting System and Electronic Prescribing (erx) Incentive Program Medicare Advantage Plan Five-star Ratings: Results Rating for the measure C20 members with urine leakage who discussed this issue with their physician and received treatment within 6 months : In 2012, 1.8 stars In 2013, 2.3 stars In 2014, 1.9 stars The Reality Is: We Can Do Better in Providing and reporting quality of care in the treatment of OAB Diagnosing and treating OAB Centers for Medicare & Medicaid Services. Part C and D Performance Data. Available at: What Does the PCP Need? Evaluation of Urinary Issues Keep It Simple Keep It Effective Keep Us from Killing Our Patients What does the PCP need?

9 It All Comes Down to Normal How many times a day does a normal person need to urinate? What is the normal volume of urine voided per micturition? Is it normal for older people to get up during the night to use the bathroom? Function of the Bladder Normal Function Storage capacity ( ml of fluid) Adequate low pressure urinary storage (bladder) Adequate outlet resistance (sphincter) Empty to completion (minimal residual) Adequate bladder contraction Absence of outlet obstruction Abnormal Function (failure to store or empty) Voiding frequently small amounts Uncontrollable urge (urgency) Incomplete emptying Hesitancy, poor stream Wein AJ. Pathophysiology and categorization of voiding dysfunction. In: Wein AJ, Kavoussi LR, Novick AC et al, eds. Campbell-Walsh Urology. 9th ed. Philadelphia, PA: W. B. Saunders/Elsevier; 2007: Function of the Prostate Normal Function Does not grow (enlarge) into the urethra; thereby, allowing unobstructed flow It is intimately associated with the continence mechanism Produces fluid for seminal emission Abnormal Function (failure of flow) Obstruction of urinary flow ( obstruction ; retention ) Sphincter damage/usually surgical ( stress incontinence ) Lower Urinary Tract Symptoms (LUTS): Bladder or Prostate? Storage (bladder) Voiding (prostate) Urgency Hesitancy Frequency Poor flow/weak stream Nocturia Intermittency Urge incontinence Straining to void Stress incontinence Terminal dribble Mixed incontinence Prolonged urination Overflow incontinence Urinary retention Wein AJ. Pathophysiology and categorization of voiding dysfunction. In: Wein AJ, Kavoussi LR, Novick AC et al, eds. Campbell-Walsh Urology. 9th ed. Philadelphia, PA: W. B. Saunders/Elsevier; 2007: Chapple CR et al. Eur Urol. 2006;49: It is all about VOLUME VOIDED and FLOW Rosenberg MT et al. Int J Clin Pract. 2010; 64: The LUTS Algorithm Provisional OAB/SI LUTS Focused HPE UA/PSA Blood Sugar Likely OAB/BPH/SI Desires Treatment? Treat for BPH Ineffective Assess and Treat OAB/SI Ineffective Refer Yes Provisional BPH Modified from Rosenberg MT et al. Int J Clin Pract. 2007;61: Unlikely OAB/BPH/SI No Effective Effective Treat or Refer Watchful Waiting Continue Meds Continue Meds HPE history, physical examination UA urinalysis PSA prostate specific antigen BPH benign prostatic hyperplasia SI stress incontinence

10 Defining LUTS Frequency Nocturia Urgency Patient considers that he/she voids too often by day Normal is <8 times per 24 hours Waking to urinate during sleep hours Considered a clinical problem if frequency is greater than twice a night Sudden compelling desire to pass urine that is difficult to defer Involuntary leakage accompanied by, or immediately UUI preceded by, urgency OAB Wet OAB with UUI OAB Dry OAB without UUI Warning Time Time from first sensation of urgency to voiding Simple Questions the PCP Can Ask Simple Screening Questions for Evaluation of OAB and Incontinence Do you get sudden urges to go to the bathroom that are so strong you can t ignore them? (OAB) How often do you go to the bathroom? Is it more than 8 times in a 24-hour period? (OAB) Do you have uncontrollable urges to urinate that sometimes result in wetting accidents? (urge incontinence) Do you leak urine on the way to the bathroom? (urge incontinence) Do you frequently get up two or more times during the night to go to the bathroom? (OAB) Do you avoid places you think won t have a nearby restroom? (OAB or urge incontinence) When in an unfamiliar place, do you make sure you know where the restroom is? (OAB or urge incontinence) Do you leak urine when you laugh, cough, or sneeze? (stress incontinence) Do you use absorbent pads to keep from wetting your clothes? (stress incontinence or urge incontinence) Abrams P et al. Neurourol Urodyn. 2002;21: Zinner N et al. Int J Clin Pract. 2006;60: Wein A et al. J Urol. 2006;175:S5-S10. Wein AJ. Am J Manag Care. 2000;6:S559-S564. Rosenberg MT et al. Can J Urol. 2014;21(Suppl 2):2-11. OABq The Evaluation of LUTS 3 of 8 queries assess bother related to urgency During the past four weeks, how bothered? Q 2: A sudden urge to urinate with little or no warning Q 3: A sudden urge to urinate with little or no warning Q 7: An uncontrollable urge to urinate Scored on Likert scale: 1 (not at all) 6 (very great deal) Validated and reliable Responsive to therapy in wet and dry subjects Coyne KS al. Neurourol Urodyn. 2007;26: Medical and surgical history Medications Focused physical examination Voiding diary Labs Urodynamics, cystoscopy, and diagnostic renal and bladder ultrasound not necessary in initial workup of uncomplicated patients American Urological Association (AUA) Guideline. AUA Web site Accessed March 21, Examples in the Medical and Surgical History that May Cause LUTS Diabetes (new onset or poorly controlled) Causing polyuria/polydipsia Congestive heart failure Nighttime fluid mobilization Recent surgery Catheterization during surgery, immobilization, constipation from pain medications A recent onset of the symptoms may provide a clue to the etiology Medications as a Cause of LUTS Sedatives Alcohol, Caffeine, Diuretics Anticholinergics α Agonists ß - Blockers Calcium-Channel Blockers ACE Inhibitors First generation antihistamines Cholinesterase inhibitors Opioids Wyman JF et al. Int I Clin Pract. 2009;63: Newman DK. Nurse Pract. 2009;34: Confusion, secondary incontinence Diuresis Impair contractility, voiding difficulty, overflow incontinence Increased outlet resistance, voiding difficulty Decreased urethral closure, stress incontinence Reduce bladder smooth-muscle contractility Induce cough, stress urinary incontinence Increase outlet resistance Precipitate urge incontinence Direct effect, constipation

11 The Focused Physical Examination Abdominal Tenderness, masses, distension Neurological Mental and ambulatory status, neuromuscular function Genitourinary Meatus and testis Vaginal mucosal integrity, urethral mobility, bladder prolapse Rectal Tone Prostate size, shape, nodules, and consistency Laboratory Tests Urinalysis Infection, blood The urine is not an adequate screener for diabetes since the blood sugar must be above 180 mg/dl before it spills into the urine A random or fasting blood sugar Diabetes Prostate-specific antigen Prostate-specific, not cancer-specific, but can be used in screening Excellent as a surrogate marker for prostate size PSA is more accurate than a DRE when estimating prostate size A PSA of 1.5 ng/ml equates to a prostate volume of at least 30 grams(ml) Rosenberg MT et al. Cleve Clin J Med. 2007;74(suppl 3):S21-S29. Rosenberg MT et al. Can J Urol. 2014;21 Suppl 2:2-11 Rosenberg MT et al. Int J Clin Pract. 2007;61,9, Rosenberg MT et al. Can J Urol. 2014;21 Suppl 2:2-11. Bosch J et al. Eur Urol. 2004;46: Roerborn CG et al. Urology. 1999;53; The Purpose of the Voiding Diary Identifies voiding frequency and voided volume Differentiates behavioral vs LUTS pathology Voiding frequently excessive volume (behavioral) small amounts as a result of always being in a rush (behavioral) small amounts (OAB) Alerts patients to habits/opportunities to modify Can monitor effect of treatment Wyman JF et al. Int J Clin Pract. 2009;63: The Post-void Residual (PVR) Is Only Needed in Select Patients The fear of patients going into retention when treated for OAB leaves many patients untreated If PVR residual is less than 50 ml, causing retention when treating OAB is extremely unlikely FACT: most PCPs will not have bladder scanner and will not want to catheterize a patient FACT: most PCPs will have access to an ultrasound unit and can order a post-void residual Use common sense, if you are treating the patient for voiding too frequently (OAB) and they have not voided in 6-8 hours or have a sense to void but cannot, have them contact you Rosenberg MT. Curr Opin Urol. 2008;9: Rosenberg MT et al. Int J Clin Pract. 2007;61: Indications for Referral History of recurrent urinary tract infections or other infection Pelvic irradiation Microscopic or gross hematuria Prior genitourinary surgery Elevated prostate-specific antigen Abnormal genital exam Suspicion of neurological cause of symptoms Meatal stenosis History of genitourinary trauma Pelvic pain Uncertain diagnosis or patient choice Rosenberg MT et al. Int J Clin Pract. 2007;61: The LUTS Algorithm Provisional OAB/SI LUTS Focused HPE UA/PSA Blood Sugar Likely OAB/BPH/SI Desires Treatment? Treat for BPH Ineffective Assess and Treat OAB/SI Ineffective Refer Yes Provisional BPH Modified from Rosenberg MT et al. Int J Clin Pract. 2007;61: Unlikely Treat or Refer OAB/BPH/SI No Watchful Waiting Effective Continue Meds Effective Continue Meds HPE history, physical examination UA urinalysis PSA prostate specific antigen BPH benign prostatic hyperplasia SI stress incontinence

12 Treatment Now Can Be Empiric No identifiable etiology No reversible causes Is patient bothered enough for treatment? No, watchful waiting Yes, consider algorithm Weak flow think Prostate Poor voiding volumes think Bladder Incontinence think Bladder/Outlet Treatment Guidelines for OAB Behavioral treatment Pharmacologic management Referral for specialist management/surgery Rosenberg MT. Curr Urol Rep. 2008;9: Kirby M et al. Int J Clin Pract. 2006;60: Burgio K et al. J Am Geriatr Soc. 2000;48: Gormley EA et al. J Urol. 2015;23. pii: S (15) doi: /j.juro Behavioral Therapy for OAB Habit Changes: Managing Bladder Health Bladder training Pelvic floor Exercises biofeedback Education reinforcement Behavioral Therapy for OAB Timed voiding Diaries Fluid/dietary management Lifestyle Modification Timed/ Prompted Voiding Technique Diet, fluid, bowel, and weight management Smoking cessation Urination at a fixed interval that avoids the symptom Useful for urgency and urinary incontinence not associated with frequency Good option in patients with cognitive impairment No matter what the treatment course, behavioral modification should be offered to every patient Soda T et al. J Urol. 2010;184: Wyman JF et al. Int J Clin Pract. 2009;63: Wagg AS et al. BJU Int. 2007;99: Lucas MG, et al. Eur Urol. 2012;62: How to Perform Pelvic Floor Muscle Exercises Additive Effect of Combining Behavioral and Drug Therapy Explain location of perineal muscles (anal area) Contract perineal muscles, squeezing upward through the pelvis Sit or stand with your legs apart, don t hold your breath Hold the contraction for 10 seconds, then gradually relax Repeat at least 5 times, increase to per day in groups of 10 Relaxation is as important as contraction for muscle rehabilitation Use exercises to control symptoms e.g. during urge episode, not during urination The exercises can be performed anywhere Mean Reduction in UI, % Behavioral Therapy 57.5% P<0.05 Combined Therapy 88.5% Drug Therapy 72.7% Combined Therapy P= % Harv Womens Health Watch. Available at: January/how-to-perform-kegel-exercises. Burgio KL et al. J Am Geriatr Soc. 2000;48:

13 Pharmacologic Management 8 antimuscarinics, 6 are oral and 2 are topical One β-3 adrenergic agonist Choice is based on efficacy, dose flexibility, adverse-event profile, drug interactions, and patient preferences Trying several medications before referral is appropriate Receptor Pathways for OAB Treatment Acetylcholine ACH (contraction) Detrusor smooth muscle (relaxation) Antimuscarinics M 3 muscarinic receptor NE 3 agonist Norepinephrine + 3 AR Takeda M et al. J Pharmacol Sci. 2010;2110: Fowler CJ et al. Nat Rev Neurosci. 2008;8: Antimuscarinics Immediate Release Drug Brand Name Dose Dosing Oxybutynin IR Ditropan 5 mg 2-4 times per day Tolterodine IR Detrol 1-2 mg Twice per day Trospium Chloride Sanctura 20 mg Twice per day Antimuscarinics Extended Release Extended Release Medications Have a Better Tolerability than Their Immediate Release Counterparts Drug Brand Name Dose Dosing Darifenacin Enablex 7.5 mg, 15 mg Daily Fesoterodine Toviaz 4 mg, 8 mg Daily Oxybutynin ER Ditropan XL 5 30 mg Daily Oxybutynin TDS Oxytrol 3.9 mg Twice per week Oxybutynin 10% gel Gelnique 100 mg Daily Solifenacin Vesicare 5 mg, 10 mg Daily Tolterodine ER Detrol LA 2, 4mg Daily Trospium Chloride Sanctura XR 60 mg Daily Physcians Desk Reference. 64 th ed. Montvale, NJ: Thomson PDR; Physcians Desk Reference. 64 th ed. Montvale, NJ: Thomson PDR; Important Distribution Site for Antimuscarinics CNS Iris/ciliary body Lacrimal gland Salivary glands Heart Gallbladder Stomach Colon Common Side Effects of Antimuscarinics Dry mouth Constipation Headaches Blurred vision Clinicians should manage constipation and dry mouth before abandoning effective antimuscarinic therapy.. Balance of efficacy and tolerability should be considered and discussed with each patient. Abrams P, Wein AJ. The Overactive Bladder A Widespread and Treatable Condition Bladder (detrusor muscle) Steers WD. Urol Clin North Am. 2006;33: Erdam N et al. Am J. Med. 2006;119(suppl 1): Gormley EA et al. American Urological Association (AUA) Guideline. AUA Web site Available at:

14 Contraindications, Warnings, and Precautions for Antimuscarinics Contraindications Urinary or gastric retention Uncontrolled narrow-angle glaucoma Warnings and Precautions Angioedema of face, lips, tongue and/or larynx Clinically significant bladder outlet obstruction Decreased gastrointestinal motility Treated narrow-angle glaucoma May have CNS effects (i.e. somnolence) Use with caution in patients with myasthenia gravis β-3 Adrenergic Agonists Drug Brand Name Dose Dosing Mirabegron Mybetriq 25 mg, 50 mg Daily Physicians Desk Reference. 64 th ed. Montvale, NJ: Thomson PDR; Oelke M et al. Eur Urol. 2013;64: Myrbetriq (mirabegron) prescribing information. Astellas Pharma US, Inc. June Common Side Effects of Mirabegron Hypertension Nasopharyngitis Urinary Tract Infections Headaches The patient must decide if the efficacy of the medication is worth the side effects. Balance of efficacy and tolerability should be considered and discussed with each patient. Contraindications, Warnings, and Precautions for Mirabegron Contraindications NONE Precautions and Warnings Not recommended for use in severe uncontrolled hypertensive patients Use with caution in patients with urinary retention with bladder outlet obstruction Use with caution in patients taking antimuscarinic drugs for overactive bladder Use with caution in patients taking drugs metabolized by CYP2D6 as mirabegron is a moderate inhibitor of CYP2D6 Myrbetriq (mirabegron) prescribing information. Astellas Pharma US, Inc. June Myrbetriq (mirabegron) prescribing information. Astellas Pharma US, Inc. June Follow-up on the Patient Treated for OAB Review the patient after 2-4 weeks Be prepared to titrate as studies show >50% will increase dose if given the option Be prepared to try different agent or class Consider checking PVR to ensure volume not increasing significantly in the complex patient Studies on medication usage in males show safety and minimal increase in post-void residual over time of follow-up The risk of urinary retention (although low) is highest during the first 30 days of treatment High Discontinuation Rate for Patients on OAB Therapy Discontinuation Rate (%) From Anticholinergics for OAB (95% CI)* Months to Discontinuation Study Design: UK study. Overall drug discontinuation for all women prescribed anticholinergic medications (n=29,369). Unadjusted cumulative incidence of discontinuation (95% CI) Chapple CG, Rosenberg MT, Brenes FJ. Brit J Urol. 2009;104: Rosenberg MT et al. Int J Clin Pract. 2007;61: Martin-Merino E, et al. J Urol. 2009;182: Rosenberg M et al. Cleve Clin J Med. 2007;74(suppl 3):S21-S29. Myrbetriq (mirabegron) prescribing information. Astellas Pharma US, Inc. June *Cumulative incidence of discontinuation was determined using the Kaplan-Meier method. Adapted from Gopal M et al. Obstet Gynecol. 2008;112:

15 Improving Patient Adherence by Addressing Expectations Effects on urgency Limiting incontinence Decreasing nocturia Improved quality of life Tolerability of medication Options for the Unsatisfied Patient Sacral Nerve Stimulation Percutaneous Tibial Nerve Stimulation Onabotulinum Toxin A Rosenberg MT. Cur Uro 2008, 9: DeCastro J et al. Am J Med. 2008;121:S27-S33. Gormley EA et al. AUA/SUFU Guideline Available at: Take Home Message Overactive bladder doesn t take your life it steals it from you The untreated 85% is in the PCP office OAB can be diagnosed and treated in the primary care office efficiently, effectively, and safely Treating OAB Takes a Village Be willing to discuss his/her symptoms Make recommended lifestyle changes Adhere to prescribed medication Diagnose OAB Set realistic patient expectations/goals Provide initial treatment of OAB Refer appropriate patients Treat refractory or complicated OAB Educate PCPs to better manage OAB Rosenberg MT. Curr Urol Rep. 2008;9: Yu YF et al. Value Health. 2005;8: PRS Measures to Report Reporting in Practice 48 (NQF 0098) Urinary Incontinence: Assessments of presence or absence of urinary incontinence in women 65 years and older 50 (QF 0100): urinary incontinence: plan of care for urinary incontinence and women age 65 years and older

16 Build PQRS OAB Reporting into Your Workflow 1. Add the appropriate questions to your patient history questionnaire 2. Develop detailed questions for patients with a problem to be discussed/documented by assistant, PA, and/or physician 3. PE as needed 4. For claims reporting, submit Measure with the appropriate visit once per year per patient 5. Audit charts periodically to determine if all eligible patients have been reported A Brief Guide to Quality Reporting for OAB