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OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer Emerging Challenges In Primary Care: 2014 ! OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer Faculty Pamela Ellsworth, MD Professor of Urology Department of Urology UMass Memorial Medical Center/University of Massachusetts Medical School Worcester, MA Louis Kuritzky, MD Clinical Assistant Professor Department of Community Health & Family Medicine University of Florida Gainesville, FL Matt T. Rosenberg, MD Medical Director of MidMichigan Health Centers Jackson, MI Section Editor of Urology, International Journal of Clinical Practice FACULTY DISCLOSURES ² Pamela Ellsworth, MD - Speaker/Advisory Board – Pfizer, Allergan - Advisory Board – Astellas ² Louis Kuritzky, MD - No relevant relationships to disclose ² Matt T. Rosenberg, MD - Speaker/Consultant – Astellas, Horizon, Pfizer - Speaker – Forest, Ortho-McNeil - Consultant – Easai, Ferring, Lilly, Bayer 2 NACE – Emerging Challenges in Primary Care: 2014 OAB - 1 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer LEARNING OBJECTIVES After participating in this educational activity, clinicians should be better able to: 1. Recognize the role of simple questioning for identifying patients with overactive bladder (OAB) 2. Discuss the essential components of the evaluation of the patient with OAB symptoms 3. Develop a management plan for patients with OAB that emphasizes the incorporation of behavioral therapy and setting appropriate expectations, optimizes efficacy and minimizes side effects to improve patient compliance and adherence with pharmacologic therapy 4. Describe the role of recently approved second line therapies, third line therapies and future therapies in patients with OAB who are unsatisfied with antimuscarinic therapy 3 PRE-TEST QUESTION 1 On a scale of 1 to 5, please rate how confident you would be in the diagnosis and management of a patient with OAB. 1. 2. 3. 4. 5. Not at all confident Slightly confident Moderately confident Pretty much confident Very confident 4 NACE – Emerging Challenges in Primary Care: 2014 OAB - 2 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer PRE-TEST QUESTION 2 Mary is a 80 year old patient who admits during her yearly exam that she wears a diaper “just in case” she can’t make it to the bathroom in time. Which of the following is true regarding OAB? 1. OAB is less prevalent than chronic sinusitis 2. An 80 year old patient should know that it is normal to get up several times per night to empty their bladder 3. At least 50% of symptomatic patients are offered medical treatment for their symptoms of OAB 4. Understanding volume voided is a helpful point of distinction when evaluating LUTS symptoms for OAB 5 PRE-TEST QUESTION 3 When you tell Mary she may have OAB, she asks about the evaluation. Which is test is not recommended by the AUA in the initial evaluation of OAB in the uncomplicated patient? 1. Urinalysis 2. Bladder ultrasound 3. Voiding diary 4. Genital exam 6 NACE – Emerging Challenges in Primary Care: 2014 OAB - 3 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer PRE-TEST QUESTION 4 After an appropriate evaluation you discuss treatment options with Mary. Which of the following statements regarding expectations of OAB therapy is false? 1. It is appropriate to tell the patient that urinary urgency may be reduced with the correct therapy 2. It may take titration or changes in the pharmacologic therapy before an adequate response in attained 3. Therapeutic efficacy is enhanced with the combination of behavioral therapy and pharmacologic therapy as opposed to either alone 4. The risk of urinary retention in the male increases with longer duration on pharmacologic therapy for OAB 7 PRE-TEST QUESTION 5 Mary is very interested in efficacy but wants to limit side effects. Which of the following is true regarding OAB pharmacologic therapy with either an antimuscarinic or a beta 3 adenergic agonist? 1. Both classes have a high rate of dry mouth 2. The efficacy of the antimuscarinic medications are higher than the beta 3 adrenergic agonist medication 3. The efficacy of the beta 3 adrenergic agonist medication is higher than the antimuscarinic medication 4. One agent blocks contraction while the other stimulates relaxation 8 NACE – Emerging Challenges in Primary Care: 2014 OAB - 4 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer DEFINITION OF OAB OAB is 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;61:37-49. Rosenberg MT, et al. Int J Clin Pract. 2007;61:1535-1546. 9 PREVALENCE OF OAB SYMPTOMS Respondents (%) 1 in 3 US adults ≥40 years of age reported symptoms of OAB at least “sometimes” Age (years) Coyne S, et al. Urology. 2011;77:1081-1087. NACE – Emerging Challenges in Primary Care: 2014 10 OAB - 5 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer OAB & OTHER DISORDERS Chronic Bronchitis Diabetes Ulcer Asthma Hay Fever/Allergic Rhinitis Heart Disease Chronic Sinusitis Overactive Bladder Arthritic Symptoms 0 10 20 Millions 30 40 Stewart WF, et al. World J Urol. 2003;20(6):327-336. Pleis JR, Coles R. Summary health statistics for U.S. adults: National Health Interview Survey, 1998. Vital Health Stat 10. 2002;209:1-113. Centers for Disease Control and Prevention/National Center for Health Statistics. Vital and Health Statistics. Hyattsville, MD: U.S. Department of Health and Human Services; 1997. DHHS Publication No. (PHS) 97-1522. 11 «http://www.cdc.gov/nchs/data/series/sr_10/sr10_194.pdf». COPING STRATEGIES 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 Bathroom mapping Restrict fluid intake Try to urinate on a schedule 12 Rosenberg MT. Curr Urol Rep. 2008. Abrams et al. Am J Manag Care. 2000 Jul;6(11 Suppl):S580-S590. Ricci JA, et al. Clin Ther. 2001;23:1245-1259. NACE – Emerging Challenges in Primary Care: 2014 OAB - 6 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer OAB IS PREVALENT, UNDIAGNOSED AND UNDERTREATED ² 33.3 million US adults are said to have OAB ² Less than 50% will discuss with healthcare provider ² Only a minority will be diagnosed and offered treatment ² A smaller proportion will stay on therapy Stewart WF et al. World J Urol. 2003;20:327-336. Rovner E, Wein A. Curr Urol Rep. 2002;3:434-438. Milsom I et al. BJU Int. 2001;87:760-766. Benner J et al. J Urol. 2009;181:2591-2598. Rosenberg M et al. Cleve Clinic J Med. 2007;74:S21-S29. Goepel M et al. Eur Urol. 2002;41:234-239. Dmochowski RR et al. Curr Med Res Opin. 2007;23:65-76. 13 The Reality is We Can Do Better in the Identification and Treatment of OAB 14 NACE – Emerging Challenges in Primary Care: 2014 OAB - 7 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer WHY IS OAB UNDERDIAGNOSED AND UNDERTREATED? The answer is education and communication Unfortunately, if we don’t understand the disease, we may not identify it even to refer, let alone treat!!!!!! 15 IDENTIFYING OAB TAKES A VILLAGE Rosenberg MT. Curr Urol Rep. 2008;9:428-432.Yu YF, et al. Value Health. 2005;8:495-505. NACE – Emerging Challenges in Primary Care: 2014 16 OAB - 8 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer PATIENTS DON’T DISCUSS BLADDER ISSUES WITH THE PROVIDER ² ² ² Embarrassment Fear of invasive procedures or need for surgery Perception of lack of available and effective treatment Ricci JA, et al. Clin Ther 2001;23:1245–1259. Milsom I, et al. BJU Int 2001;87:760–766. 17 WHAT DO PATIENTS SAY? ² I have had this problem and did not know who to talk to ² My previous doctor told me it was part of aging ² It became a problem only when my diaper overflowed ² I thought it was normal as my sister and mother had this ² You mean going to the bathroom every hour is not normal? ² I am too embarrassed MacDiarmid S, Rosenberg, M. Curr Med Res Opin. 2005; 21:1413-1421. NACE – Emerging Challenges in Primary Care: 2014 18 OAB - 9 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer THE UROLOGIST AND THE UROGYNECOLOGIST ROLE IN THE PARTNERSHIP ² Identification and initial evaluation of OAB starts in the office of the PCP ² There is a significant amount of medically related LUTS ² The diagnosis of OAB does not require an extensive or complicated evaluation Stewart WF, et al. World J Urol. 2003;20:327-336. Darkov T, et al. Pharmacotherapy. 2005;25:511-519. Ailinger RL, et al. J Comm Health Nurs. 2005;22:135-142. Rosenberg M et al. Cleve Clinic J Med. 2007;74:S21-S29. 19 POTENTIAL MISCONCEPTIONS IN OAB ² OAB is a natural part of aging ² Diagnosis and treatment of genitourinary disease is to be determined by a specialist ² Diagnosis and treatment is outside the realm of the PCP setting MacDiarmid S, Rosenberg, M. Curr Med Res Opin. 2005;21(9):1413-1421. NACE – Emerging Challenges in Primary Care: 2014 20 OAB - 10 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer WHAT DO DOCTORS SAY? ² No time ² Treatments are not all that effective ² If it was a problem for the patient, he or she would bring it up ² 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(9):1413-1421. 21 NOT SO! ² What is the outcome of an elderly patient falling and breaking a extremity? ² What is one of the primary drivers for nursing home admission? Brown et al. J Am Geriatr Soc. 2000;48:721-725. NACE – Emerging Challenges in Primary Care: 2014 22 OAB - 11 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer Current Thinking Is a Myth 23 REALITIES OF OAB MANAGEMENT ² The PCP is the first line of contact ² Diagnosis and treatment is within the realm of the PCP setting ² Current treatments offer significant improvement of patient symptoms and patient quality of life 24 NACE – Emerging Challenges in Primary Care: 2014 OAB - 12 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer What we have here is a failure to communicate. Initially stated by the Warden in Cool Hand Luke repeated by Jackie Gleason in Smokey and the Bandit And now just shamelessly used by me for lecturing amusement 25 WHAT DOES THE PCP NEED? ² Keep It Simple 26 NACE – Emerging Challenges in Primary Care: 2014 OAB - 13 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer WHAT DOES THE PCP NEED? ² Keep It Simple ² Keep It Effective 27 WHAT DOES THE PCP NEED? ² Keep It Simple ² Keep It Effective ² Keep Us From Harming Our Patients 28 NACE – Emerging Challenges in Primary Care: 2014 OAB - 14 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer IT ALL COMES DOWN TO “NORMAL” ² How many times a day does a normal person need to urinate? ² What is the normal volume of urine voided per micturition? ² Is it normal for older people to get up during the night to use the bathroom? 29 What are the normal functions of the bladder? 30 NACE – Emerging Challenges in Primary Care: 2014 OAB - 15 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer FUNCTION OF THE BLADDER ² Normal Function - Storage capacity (300 – 500 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 ² 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; 2007:1973-1985. 31 What are the normal functions of the prostate? 32 NACE – Emerging Challenges in Primary Care: 2014 OAB - 16 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer FUNCTION OF THE PROSTATE ² 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 ² Abnormal Function (failure of flow) - Obstruction of urinary flow (“obstruction” “retention”) - Sphincteric damage /usually surgical - (“stress incontinence”) 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; 2007:1973-1985. 33 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 Chapple CR, et al. Eur Urol. 2006;49:651-658. NACE – Emerging Challenges in Primary Care: 2014 34 OAB - 17 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer It is all about VOLUME VOIDED and FLOW Rosenberg MT, et al. Int J Clin Pract. 2010; 64(4):488-496. 35 Guess What Happens When You Understand What is Normal? 36 NACE – Emerging Challenges in Primary Care: 2014 OAB - 18 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer Guess What Happens When You Understand What is Normal? ² Your patients will understand what is normal, and subsequently, what is abnormal 37 Guess What Happens When You Understand What is Normal? ² Your patients will understand what is normal, and subsequently, what is abnormal ² You recognize when you have something to fix 38 NACE – Emerging Challenges in Primary Care: 2014 OAB - 19 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer THE LUTS ALGORITHM Key: LUTS – lower urinary tract symptoms HPE – history, physical examination UA – urinalysis PSA – prostate specific antigen BPH – benign prostatic hyperplasia OAB – overactive bladder SI – stress incontinence LUTS Focused HPE UA/PSA Blood Sugar Unlikely OAB/BPH/SI Treat or Refer Likely OAB/BPH/SI Desires Treatment? Provisional OAB/SI No Watchful Wai@ng Effec@ve Con@nue Meds Yes Provisional BPH Treat for BPH Ineffec@ve Assess and Treat OAB/SI Effec@ve Con@nue Meds Ineffec@ve Refer 39 Modified from Rosenberg MT, Staskin DR, Kaplan SA, et al. Int J Clin Pract. 2007;61(9):1535-1546. DEFINING LUTS Frequency • Patient considers that he/she voids too often by day • Normal is < 8 times per 24 hours Nocturia • Waking to urinate during sleep hours • Considered a clinical problem if frequency is greater than twice a night Urgency • Sudden compelling desire to pass urine that is difficult to defer UUI • Involuntary leakage accompanied by, or immediately preceded by, urgency OAB “Wet” • OAB with UUI OAB “Dry” • OAB without UUI Warning Time • Time from first sensation of urgency to voiding Abrams P, et al. Neurourol Urodyn. 2002;21:167-78; Wein A, et al. J Urol. 2006;175:S5-10; Zinner N, et al. Int J Clin Pract. 2006;60:119-26; Wein AJ. Am J Manag Care. 2000;6:S559-64. NACE – Emerging Challenges in Primary Care: 2014 40 OAB - 20 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer SIMPLE QUESTIONS THE PCP CAN ASK ² Do you have a sudden urge to void and can barely make it to the bathroom? ² Do you wear a pad or diaper? ² Can you sit through a movie without going to the bathroom? ² Do you leak urine? ² Do you get up at night? Abrams P, et al. Neurourol Urodyn. 2002;21:167-78; Wein A, et al. J Urol. 2006;175:S5-10;Zinner N, et al. Int J Clin Pract. 2006;60:119-26; Wein AJ. Am J Manag Care. 2000;6:S559-64. 41 THE EVALUATION OF LUTS ² ² ² ² ² ² 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 Gormley EA, et al. American Urological Association (AUA) Guideline. AUA Web site. 2012. http://www.auanet.org/content/ 42 media/OAB_guideline.pdf. Accessed March 21, 2014. NACE – Emerging Challenges in Primary Care: 2014 OAB - 21 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer EXAMPLES IN THE MEDICAL AND SURGICAL HISTORY THAT MAY CAUSE LUTS ² Diabetes (new onset or poorly controlled) - Causing polyuria/polydipsia ² Congestive heart failure - Nighttime fluid mobilization ² Recent Surgery - Catheterization during surgery, immobilization, constipation from pain medications A recent onset of the symptoms may provide a clue to the etiology 43 MEDICATIONS AS A CAUSE OF LUTS Sedatives Confusion, secondary incontinence Alcohol, Caffeine, Diuretics Diuresis Anticholinergics Impair contractility, voiding difficulty, overflow incontinence α – Agonists Increased outlet resistance, voiding difficulty ß - Blockers Decreased urethral closure, stress incontinence Calcium-Channel Blockers Reduce bladder smooth muscle contractility ACE Inhibitors Induce cough, stress urinary incontinence First generation antihistamines Increase outlet resistance Cholinesterase inhibitors Precipitate urge incontinence Opioids Direct effect, constipation Wyman JF, et al. Int I Clin Pract. 2009;63:1177-1191. Newman DK. Nurse Pract. 2009;34:33-45. NACE – Emerging Challenges in Primary Care: 2014 44 OAB - 22 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer THE FOCUSED PHYSICAL EXAMINATION ² Abdominal – Tenderness, masses, distension ² Neurological – Mental and ambulatory status, neuromuscular function ² Genitourinary – – Meatus and testis Vaginal mucosal integrity, urethral mobility, bladder prolapse ² Rectal – – Tone Prostate size, shape, nodules and consistency Rosenberg MT, Newman DK, Tallman CT, et al. Cleve Clin J Med. 2007;74(suppl 3):S21-S29. 45 LABORATORY TESTS ² 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 ² A random or fasting blood sugar – Diabetes ² 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, Staskin DR, Kaplan SA, et al. Int J Clin Pract. 2007;61,9,1535-1546. Bosch J, et al. Eur Urol. 2004;46:753-759 Roerborn CG, et al. Urology. 1999;53;381-9. 46 NACE – Emerging Challenges in Primary Care: 2014 OAB - 23 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer THE PURPOSE OF THE VOIDING DIARY ² Identifies voiding frequency and voided volume ² 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) ² Alerts patients to habits /opportunities to modify ² Can monitor effect of treatment Wyman JF, et al. Int J Clin Pract. 2009; 63(8):1177-91 47 THE POST VOID RESIDUAL (PVR) IS ONLY NEEDED IN SELECT PATIENTS ² The fear of patients going into retention when treated for OAB leaves many patients untreated ² 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 a ultrasound unit and can order a post void residual ² 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(6):428-32. Rosenberg MT, Staskin DR, Kaplan SA, et al. Int J Clin Pract. 2007;61(9): 1535-1546. 48 NACE – Emerging Challenges in Primary Care: 2014 OAB - 24 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer INDICATIONS FOR REFERRAL ² History of recurrent urinary tract infections or other infection ² Pelvic irradiation ² Microscopic or gross hematuria ² Prior genitourinary surgery ² Elevated prostate-specific antigen ² Abnormal genital exam ² Suspicion of neurological cause of symptoms ² Meatal stenosis ² History of genitourinary trauma ² Pelvic pain ² Uncertain diagnosis or patient choice Rosenberg MT, Staskin DR, Kaplan SA, et al. Int J Clin Pract. 2007;61(9),1535-1546 49 TREATMENT NOW CAN BE EMPIRIC ² No identifiable etiology ² No reversible causes ² 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 Rosenberg MT. Cur Uro 2008;9:428–432. NACE – Emerging Challenges in Primary Care: 2014 50 OAB - 25 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer THE MALE (OR PROSTATE) DILEMMA LUTS Focused HPE UA/PSA Blood Sugar Unlikely OAB/BPH/SI Treat or Refer Likely OAB/BPH/SI Desires Treatment? Provisional OAB/SI Key: LUTS – lower urinary tract symptoms HPE – history, physical examination UA – urinalysis PSA – prostate specific antigen BPH – benign prostatic hyperplasia OAB – overactive bladder SI – stress incontinence No Watchful Wai@ng Effec@ve Con@nue Meds Yes Provisional BPH Treat for BPH Ineffec@ve Assess and Treat OAB/SI Effec@ve Con@nue Meds Ineffec@ve Refer Modified from Rosenberg MT, Staskin DR, Kaplan SA, et al. Int J Clin Pract. 2007;61(9):1535-1546. 51 TREATMENT GUIDELINES FOR OAB ² Behavioral treatment ² Pharmacologic management ² Referral for specialist management/surgery Gormley EA, et al. American Urological Association (AUA) Guideline. AUA Web site. 2012. http://www.auanet.org/content/ media/OAB_guideline.pdf. Accessed March 21, 2014. Kirby M, et al. Int J Clin Pract. 2006;60:1263-1271.Burgio K, et al. J Am Geriatr Soc. 2000;48:370-374 . 52 NACE – Emerging Challenges in Primary Care: 2014 OAB - 26 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer BEHAVIORAL THERAPY FOR OAB Educa:on reinforcement Bladder training Diaries Behavioral Therapy for OAB Pelvic floor exercises Biofeedback Fluid/Dietary management Timed voiding No matter what the treatment course, behavioral modification should be offered to every patient Soda T, et al. J Urol. 2010; 184: 1000-1004 53 HABIT CHANGES: MANAGING BLADDER HEALTH Technique Lifestyle Modification Timed/ Prompted Voiding 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 Wyman JF, et al. Int J Clin Pract. 2009;63:1177-91. Wagg AS, et al. BJU Int. 2007;99:502-9. Lucas MG, et al. Eur Urol 2012;62(6):1130-42. NACE – Emerging Challenges in Primary Care: 2014 54 OAB - 27 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer HOW TO PERFORM PELVIC FLOOR MUSCLE EXERCISES ² Explain location of perineal muscles (anal area) ² Contract perineal muscles, squeezing upward through the pelvis ² Sit or stand with your legs apart, don’t hold your breath ² Hold the contraction for 10 seconds, then gradually relax ² Repeat at least 5 times, increase to 30-40 per day in groups of 10 ² Relaxation is as important as contraction for muscle rehabilitation ² Use exercises to control symptoms - eg, during urge episode, not during urination The exercises can be performed anywhere 55 Harv Womens Health Watch. www.health.harvard.edu/newsletters/Harvard_Womens_Health_Watch/2011/ January/how-toperform-kegel-exercises. ADDITIVE EFFECT OF COMBINING BEHAVIORAL AND DRUG THERAPY Behavioral Combined Therapy Therapy Drug Therapy Combined Therapy Mean Reduction in UI, % 0 –20 –40 –60 –80 –100 –57.5% –72.7% –88.5% P < .05 Burgio KL, et al. J Am Geriatr Soc. 2000;48:370-374. NACE – Emerging Challenges in Primary Care: 2014 –84.3% P = .001 56 OAB - 28 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer PHARMACOLOGIC MANAGEMENT ² 8 antimuscarinics, 6 are oral and 2 are topical ² 1 beta-3 adrenergic agonist ² Choice is based of efficacy, dose flexibility, adverse event profiles, drug interactions and patient preference ² Trying several medications before referral is appropriate 57 RECEPTOR PATHWAYS FOR OAB TREATMENT Acetylcholine ACH Antimuscarinics – M3 muscarinic receptor (contraction) Detrusor smooth muscle (relaxation) β3 agonist NE + Norepinephrine β3 AR Takeda M, et al. J Pharmacol Sci. 2010;2110:121-127. Fowler CJ, et al. Nat Rev Neurosci. 2008;8:453-466. NACE – Emerging Challenges in Primary Care: 2014 58 OAB - 29 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer ANTIMUSCARINICS – IMMEDIATE RELEASE Drug Brand Name Dose Dosing Oxybutynin IR Ditropan 5 mg 1 – 3 times per day Tolterodine IR Detrol 1 -2 mg Twice per day Trospium Chloride Sanctura 20 mg Twice per day 59 Physcians’ Desk Reference. 64st ed. Montvale, NJ: Thomson PDR; 2010. 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. 64st ed. Montvale, NJ: Thomson PDR; 2010. NACE – Emerging Challenges in Primary Care: 2014 60 OAB - 30 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer COMMON SIDE EFFECTS OF ANTIMUSCARINICS ² ² ² ² 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. Steers WD. Urol Clin North Am. 2006;33:475-482. Erdam N, et al. Am J. Med 2006;119(suppl 1):29-36. Gormley EA, et al. American Urological Association (AUA) Guideline. AUA Web site. 2012. http://www.auanet.org/content/media/OAB_guideline.pdf. Accessed March 21, 2014. 61 CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS FOR ANTIMUSCARINICS ² Contraindications- Urinary or gastric retention - Uncontrolled narrow-angle glaucoma ² Warnings & 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 Physicians’ Desk Reference. 64st ed. Montvale, NJ: Thomson PDR; 2010. Oelke M, et al. Eur Urol. 2013;64(1):118-140. NACE – Emerging Challenges in Primary Care: 2014 62 OAB - 31 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer BETA-3 ADRENERGIC AGENTS Drug Brand Name Dose Dosing Mirabegron Myrbetriq 25 mg, 50 mg Daily Myrbetriq™ (mirabegron) prescribing information, Astellas Pharma US, Inc. June 2012. 63 COMMON SIDE EFFECTS OF MIRABEGRON ² ² ² ² Hypertension Nasopharyngitis Urinary Tract Infections Headaches Balance of efficacy and tolerability should be considered and discussed with each patient. Myrbetriq™ (mirabegron) prescribing information, Astellas Pharma US, Inc. June 2012. NACE – Emerging Challenges in Primary Care: 2014 64 OAB - 32 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS FOR MIRABEGRON ² Contraindications – NONE ² Precautions & Warnings – - Not recommended for use in severe uncontrolled hypertensive patients - Use with caution in patients with urinary retention or bladder outlet obstruction - Use with caution in patients taking antimuscarinic drugs for overactive bladder - Caution with use in patients taking drugs metabolized by CYP2D6 as mirabegron is a moderate inhibitor of CYP2D6 Myrbetriq™ (mirabegron) prescribing information, Astellas Pharma US, Inc. June 2012. 65 FOLLOW UP ON THE PATIENT TREATED FOR OAB ² 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 ² 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 Chapple CG, Rosenberg MT, Brenes FJ. Brit J Urol. 2009;104(7):960-7. Rosenberg MT, Staskin DR, Kaplan SA, et al. Int J Clin Pract. 2007;61(9):1535-1546. Martin-Merino E, et al. J Urol. 2009; 182(4):1442-8. Rosenberg M, Newman DK, Tallman CT, et al. Cleve Clin J Med. 2007;74(suppl 3):S21-S29. Myrbetriq™ (mirabegron) prescribing information, Astellas Pharma US, Inc. June 2012. 66 NACE – Emerging Challenges in Primary Care: 2014 OAB - 33 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer Discontinuation Rate (%) From Anticholinergics for OAB (95% CI)* HIGH DISCONTINUATION RATE FOR PATIENTS ON OAB THERAPY Adapted from Gopal et al. 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). *Cumulative incidence of discontinuation was determined using the Kaplan-Meier method. Gopal M, et al. Obstet Gynecol. 2008;112:1311-1318. 67 IMPROVING PATIENT ADHERENCE BY ADDRESSING EXPECTATIONS ² Effects on urgency ² Limiting incontinence ² Decreasing nocturia ² Improved quality of life ² Tolerability of medication Rosenberg MT. Cur Uro 2008, 9:428–432. DeCastro J, et al. Am J Med. 2008;121:S27-S33. NACE – Emerging Challenges in Primary Care: 2014 68 OAB - 34 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer OPTIONS FOR THE UNSATISFIED PATIENT ² Sacral Nerve Stimulation ² Percutaneous Tibial Nerve Stimulation ² Onabotulinum Toxin A Gormley EA, et al. American Urological Association (AUA) Guideline. AUA Web site. 2012. http://www.auanet.org/content/ media/OAB_guideline.pdf. Accessed March 21, 2014 69 TAKE HOME MESSAGE ² Overactive bladder doesn’t take your life — it steals it from you ² The untreated 85% is in the PCP office ² OAB can be diagnosed and treated in the primary care office efficiently, effectively and safely 70 NACE – Emerging Challenges in Primary Care: 2014 OAB - 35 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer 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;9:428-432.Yu YF, et al. Value Health. 2005;8:495-505. 71 POST-TEST QUESTIONS 72 NACE – Emerging Challenges in Primary Care: 2014 OAB - 36 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer POST-TEST QUESTION 1 Mary is a 80 year old patient who admits during her yearly exam that she wears a diaper “just in case” she can’t make it to the bathroom in time. Which of the following is true regarding OAB? 1. OAB is less prevalent than chronic sinusitis 2. An 80 year old patient should know that it is normal to get up several times per night to empty their bladder 3. At least 50% of symptomatic patients are offered medical treatment for their symptoms of OAB 4. Understanding volume voided is a helpful point of distinction when evaluating LUTS symptoms for OAB 73 POST-TEST QUESTION 2 When you tell Mary she may have OAB, she asks about the evaluation. Which is test is not recommended by the AUA in the initial evaluation of OAB in the uncomplicated patient? 1. Urinalysis 2. Bladder ultrasound 3. Voiding diary 4. Genital exam 74 NACE – Emerging Challenges in Primary Care: 2014 OAB - 37 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer POST-TEST QUESTION 3 After an appropriate evaluation you discuss treatment options with Mary. Which of the following statements regarding expectations of OAB therapy is false? 1. It is appropriate to tell the patient that urinary urgency may be reduced with the correct therapy 2. It may take titration or changes in the pharmacologic therapy before an adequate response in attained 3. Therapeutic efficacy is enhanced with the combination of behavioral therapy and pharmacologic therapy as opposed to either alone 4. The risk of urinary retention in the male increases with longer duration on pharmacologic therapy for OAB 75 POST-TEST QUESTION 4 Mary is very interested in efficacy but wants to limit side effects. Which of the following is true regarding OAB pharmacologic therapy with either an antimuscarinic or a beta 3 adenergic agonist? 1. Both classes have a high rate of dry mouth 2. The efficacy of the antimuscarinic medications are higher than the beta 3 adrenergic agonist medication 3. The efficacy of the beta 3 adrenergic agonist medication is higher than the antimuscarinic medication 4. One agent blocks contraction while the other stimulates relaxation 76 NACE – Emerging Challenges in Primary Care: 2014 OAB - 38 OAB Made Simple for the Primary Care Provider (PCP): How to Identify, When to Treat and When to Refer POST-TEST QUESTION 5 On a scale of 1 to 5, please rate how confident you would be in the diagnosis and management of a patient with OAB. 1. 2. 3. 4. 5. Not at all confident Slightly confident Moderately confident Pretty much confident Very confident 77 POST-TEST QUESTION 6 Which of the statements below describes your approach to diagnosing and treating patients with OAB? 1. I do not diagnose or treat patients with OAB, nor do I plan to this year. 2. I did not diagnose or treat patients with OAB before this course, but as a result of attending this course I’m thinking of managing them now. 3. I do diagnose and treat patients with OAB and I now plan to change my treatment methods based on completing this course. 4. I do diagnose and treat patients with OAB and this course confirmed that I don’t need to change my treatment 78 methods. NACE – Emerging Challenges in Primary Care: 2014 OAB - 39
