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Learning Objectives

Learning Objectives. Accurately recognize overactive bladder (OAB), with urgency as the core symptom, in the context of other urinary symptoms that are commonly encountered in men and women

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Learning Objectives

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  1. Learning Objectives • Accurately recognize overactive bladder (OAB), with urgency as the core symptom, in the context of other urinary symptoms that are commonly encountered in men and women • Confidently assess important measures like symptom severity and health-related quality of life (HRQOL) and use this information for patient management • Apply behavioral and lifestyle modifications to treatment strategies using an individualized and patient-centered approach to OAB • Understand the current first-line treatments for OAB in both men and women • Employ a patient-centered treatment strategy that explores the benefits of dosing antimuscarinics to obtain a balance between efficacy and tolerability

  2. ? Premeeting Survey • True or False: The core symptom of OAB is urgency. • True • False

  3. ? Premeeting Survey • Which of the following are NOT considered comorbidities in patients with OAB? • Falls and fractures • Urinary tract infections (UTIs) • Skin infections • Kidney stones

  4. ? Premeeting Survey • True or False: Using a flexible-dosing regimen of antimuscarinics results in improved efficacy and patient satisfaction. • True • False

  5. Overactive Bladder: Impact Matt T. Rosenberg, MD MidMichigan Health Centers Jackson, MI

  6. ICS Definition of Overactive Bladder • A symptom syndrome suggestive of lower urinary tract dysfunction1,2 • Urgency, with or without urge incontinence, usually with frequency and nocturia1,2 • In absence of metabolic or pathologic conditions1,2 1Abrams P, et al. Neurourol Urodyn. 2002;21:167-178. 2 Wein AJ, et al. Urology. 2002;60(5 suppl 1):7-12. ICS: International Continence Society

  7. Overactive Bladder Definitions 1Abrams P, et al. Neurourol Urodyn. 2002;21:167-178. 2Wein AJ, et al. J Urol. 2006;175(3 pt 2):S5-S10. 3Zinner N, et al. Int J Clin Pract. 2006;60:119-126.

  8. Holds 300-500 cc Empties < 8 times per day Holds at night After gradual filling, urge is felt Empties > 8 times per day Empties > 2 times per night Has urgency (sudden compelling desire to void that is difficult to defer) Healthy Bladder Versus Overactive Bladder Pfisterer MH-D, et al. Neurourol Urodyn. 2007;26:356-361. Wein AJ. Am J Manag Care. 2000;6(11 suppl):S559-S564. Wein AJ, et al. J Urol. 2006;175(3 pt 2):S5-S10.

  9. Men (SIFO 1997) 16.6 Women (SIFO 1997) Men (EPIC 2005) 11.8 OAB Symptoms Are as Prevalent in Men as in Women and Increase With Age Population-based prevalence studies: Comparison of data from the SIFO study (1997)*1and the EPIC study (2005)†2 40 35 30 25 Women (EPIC 2005) Prevalence (%) 20 15 10 5 0 18-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 > 70 Age (years) SIFO: Sifo/Gallup telephone survey * N = 16,776 interviews (6 European countries) † N = 19,165 interviews (4 European countries and Canada) 1Milsom I, et al. BJU Int. 2001;87:760-766. 2Irwin DE, et al. Eur Urol. 2006;50:1306-1314.

  10. Urgency Leading to Urgency Incontinence: More Prevalent in Women Women with OAB (n = 463) Men with OAB (n = 401) With UUI 16% With UUI 55% Without UUI 84% Without UUI 45% National Overactive Bladder Evaluation Study Stewart WF, et al. World J Urol. 2003;20:327-336.

  11. Overcoming Barriers in OAB: Forming an Accurate Diagnosis

  12. OAB negatively impacts QOL: Emotional well-being Social relationships Productivity Physical functioning Anxiety Hostility Depression Avoid activities like travel Fear of embarrassment Fear resulting from misconceptions Differences in perception: Symptom severity Degree of bother Willingness to seek treatment Patients Suffer Needlessly From OAB Patients Would Rather Cope With OAB Than Seek Help Due to: Khullar V, et al. Urology. 2006;68(2 suppl):38-48. Dmochowski RR, et al. Curr Med Res Opin. 2007;23:65-76.

  13. OAB Symptoms Negatively Affect Patients Percent of patients HRQOL assessed with King’s Health Questionnaire N = 2878 Sand P, et al. BJU Int. 2007;99:836-844.

  14. Women Prefer Clinicians to Initiate Discussion About Urinary Symptoms Percentage of women (agree strongly or completely) • Participant question: “I would be more comfortable discussing urinary symptoms if my health care provider brought up the topic.” (n = 389) (n = 1046) (n = 386) (n = 271) SUI: stress urinary incontinence MUI: mixed urinary incontinence MacDiarmid S, et al. Curr Med Res Opin. 2005;21;1413-1421.

  15. Look for Comorbidities of OAB P < 0.0001 • These conditions were 2.8 times more likely to occur in patients with OAB compared to controls (95% CI, 2.6-2.9): • Adjusted for neurologic conditions, diuretic use, potentially inappropriate drug use, and UTI risk factors 11,556 adult patients with OAB and 11,556 controls matched on propensity score Adapted from Darkow T, et al. Pharmacotherapy. 2005;25:511-519.

  16. ? How Do You Approach a Conversation About Urinary Problems Like OAB? • I ask 1 or more questions like, “Do you have urinary problems?” • I let the patient bring it up • I use a questionnaire • I do not routinely ask about urinary problems

  17. How to Optimally Obtain a Patient History: First Line of Questioning • Do you have urinary problems?1,2 • How much do the symptoms bother you? • Do you want medication for your problems? 1Lavelle JP, et al. Am J Med. 2006;119(3 suppl 1):37-40. 2Rosenberg MT, et al. Cleve Clin J Med. 2005;72:149-156.

  18. How to Optimally Obtain a Patient History: Second Line of Questioning Rosenberg MT, et al. Cleve Clin J Med. 2005;72:149-156. Irwin DE, et al. Eur Urol. 2006;50:1306-1314. Marschall-Kehrel D, et al. Urology. 2006;68(2 suppl):29-37.

  19. How to Optimally Obtain a Patient History: Elements of the Examination • Now that the urinary problem is identified, inquire about: • Lower urinary tract symptoms (LUTS) • Medical and surgical history • Medications • Focused physical examination • Laboratory examinations and/or tests: • Voiding diary, pad test Lavelle JP, et al. Am J Med. 2006;119(3 suppl 1):37-40. Rosenberg MT, et al. Cleve Clin J Med. 2005;72:149-156.

  20. Clinical Practice Recommendation • Practice recommendation: • Patient history in combination with pad tests and urinary diaries is effective in diagnosing OAB • Evidence-based source: • Health Technology Assessment • Web site of supporting evidence: • http://www.ncchta.org/fullmono/mon1006.pdf • Strength of evidence: • Of 6009 papers, 121 were relevant for inclusion in the review: • Comparison of 2 or more assessment/diagnostic techniques • Simple investigations (eg, pad test and diary) may offer useful information on severity • Combined with history, process may provide sufficient information to commence primary care interventions (which are low cost and low risk)

  21. Case Study 1: CarolPresentation • Carol, aged 55 years, has been a long-term patient of yours and presents to your office to check on her hypertension and get a new prescription • She seems hesitant to leave after the examination and you question her on other troubling symptoms • She admits to experiencing OAB symptoms with great bother: • Frequency has increased in the past 6 months • Nocturia • Medical history: • Previously treated for depression and UTIs • Hypertension treated with diuretic and calcium channel blocker • Atrophic vaginitis testing was unremarkable

  22. ? What Is Your Initial Approach to Treating Carol? • Behavioral modifications • Pharmacotherapy • Combination of behavioral modifications and pharmacotherapy • I ask the patient for her treatment goals and preference first • I do not treat OAB

  23. Behavioral Modifications Are a Good Starting Point • Bladder training: scheduled voiding/voiding deferment1,2 • Pelvic floor exercises1-4: • Can be easily performed at home with no equipment needed • Not associated with significant adverse events • Significant impact in women with UUI and MUI • Evidence for men lacking • Significantly higher cure rates and satisfaction associated with combined bladder training and pelvic floor exercises than either therapy alone4 1Christofi N, et al. Menopause Int. 2007;13:154-158. 2Newman DK. Am J Nurs. 2002;102:36-45. 3Burgio KL. J Am Acad Nurse Pract. 2004;16(10 suppl):4-7. 4Milne JL. J Wound Ostomy Continence Nurs. 2008;35:93-101.

  24. Clinical Practice Recommendation • Practice recommendation: • Behavioral therapy improves symptoms of UUI and MUI • Evidence-based source: • National Guideline Clearinghouse • Web site of supporting evidence: • http://www.guideline.gov/summary/summary.aspx?doc_id=10931&nbr=005711&string=incontinence • Strength of evidence: • Level A • Can be recommended as a noninvasive treatment in many women

  25. Lifestyle Modifications in OAB:Current Evidence Is Sparse and Inconsistent • Caffeine reduction dose dependent1: • Affects patients consuming ≥ 400 mg caffeine or 2.5 cups of coffee • Weight loss1: • Significant reduction in UUI reported: • No data in men or in OAB dry or moderately overweight patients • Adjusting fluid intake1,2: • Greater impact than caffeine restriction • For significant improvement in urgency, frequency, and nocturia episodes, modify fluid input by 25% (goal: 1500-2400 mL/day) • Few data for smoking cessation and regulation of bowel function2 1Milne JL. J Wound Ostomy Continence Nurs. 2008;35:93-101. 2Newman DK, et al. Am J Nurs. 2002;102:36-45.

  26. Case Study 1: CarolTreatment • Low-dose antimuscarinic with daily dosing • Take diuretic before bedtime to improve nocturia • Behavioral modifications

  27. OAB in Female Patients

  28. Differential Diagnosis of Symptoms in Women With OAB Rosenberg MT, et al. Cleve Clin J Med. 2007;74(suppl 3):S21-S29.

  29. Incontinence on physical activity Incontinence with mixed symptoms Incontinence with urgency/frequency Evaluation SUI MUI UUI Pelvic floor muscle training Bladder retraining Treat most bothersome symptoms for MUI Antimuscarinics ICI Management of Incontinencein Women ICI: International Consultation on Incontinence Adapted from Kirby M, et al. Int J Clin Pract. 2006;60:1263-1271.

  30. Treatment Strategies and Pharmacotherapy for OAB David R. Staskin, MD New York Presbyterian Hospital New York, NY

  31. Treatment Goals for OAB Hegde SS. Br J Pharmacol. 2006;147(suppl 2):S80-S87. Staskin DR, et al. Am J Med. 2006;119(3 suppl 1):9-15. Cardozo L, et al. J Urol. 2005;173:1214-1218.

  32. Patient and Physician Expectations • Not tailoring treatment may lead to2: • Disillusionment • Avoidable adverse events • Unneeded use of time and resources • Harmful and unnecessary surgery • Morbidity/mortality • Worsening symptoms Tailor to2: • Environment • Expectations • Lifestyle • Age • Health 1Robinson D, et al. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18:273-279. 2Cardozo L. BJU Int. 2007;99(suppl 3):1-7.

  33. Clinical Practice Recommendation • Practice recommendation: • Antimuscarinics significantly reduce OAB symptoms • Evidence-based source: • Cochrane Database of Systematic Reviews • Web site of supporting evidence: • http://www.cochrane.org/reviews/en/ab003781.html • Strength of evidence: • 61 trials included in the review • The use of anticholinergic drugs for OAB results in statistically significant improvements in symptoms

  34. Symptom-Based OAB Management Patient perception of improvement in overall bladder condition at week 12*1 Questionnaires used: OAB symptom questionnaire (OAB-q) American Urological Association Symptom Index Patient Perception of Bladder Condition (PPBC) 863 patients from 82 primary care and 16 obstetric/gynecology offices1,2 • OAB symptoms ≥ 3 months; at least moderately bothered by most bothersome symptom • 69% of patients had ≥ 1 comorbid condition; none of the patients had retention requiring catheterization * IMPACT: tolterodine extended release (ER) 12-week, open-label study 1Roberts R, et al. Int J Clin Pract. 2006;60:752-758. 2Elinoff V, et al. Int J Clin Pract. 2006;60:745-751.

  35. Pros and Cons: Antimuscarinics Adapted fromChapple C, et al. Eur Urol. 2008;54:226-230.

  36. Potential Adverse Events, Contraindications, and Drug Interactions of Antimuscarinics * eg, paroxetine (SSRI) shares CYP2D6 liver metabolism with darifenacin † eg, ketoconazole, fluoxetine (SSRI) SSRI: selective serotonin reuptake inhibitor 1Steers WD. Urol Clin North Am. 2006;33:475-482. 2Erdem N, et al. Am J Med. 2006;119(3 suppl 1):29-36. 3Staskin DR. Drugs Aging. 2005;22:1013-1028. 4Physicians’ Desk Reference. 62nd ed. Montvale, NJ: Thomson PDR; 2008. 5Swart PJ, et al. Basic Clin Pharmacol Toxicol. 2006;99:33-36.

  37. Adverse Events Decline Over Time* Consistent finding across long-term studies for OAB: adverse events are most common within 3 months of therapy and decline thereafter Percent of patients Treatment duration (months) N = 716 * 24-month, noncomparative, darifenacin, open-label extension study Haab F, et al. BJU Int. 2006;98:1025-1032.

  38. Behavioral therapy Combined therapy* Pharmacologic therapy Combined therapy* 0 –10 –20 –30 –40 Mean reduction in UUI (%) –50 –60 –57.5 –70 –72.7 –80 –90 –84.3 –88.5 –100 P = 0.001 P = 0.034 Enhanced Therapeutic Effects With Combined Pharmacologic and Behavioral Therapy N = 197 * Behavioral therapy and pharmacotherapy Burgio KL, et al. J Am Geriatr Soc. 2000;48:370-374.

  39. Outcome Measures • Objective versus subjective measures • Metrics for urgency: • Urgency severity • Warning time

  40. Correlation of Subjective and Objective Measures Coyne KS, et al. Int J Clin Pract. 2008;62:925-931.

  41. Weeks 1 4 12 0 –0.1 –0.2 P = 0.0002 P = 0.0008 –0.3 P = 0.0004 –0.4 Trospium 60 mg daily Placebo (n = 292) (n = 300) –0.5 Metrics for Urgency: Reduction in Urgency Severity Reduction in urgency severity score/void (IUSS) from baseline Trospium significantly reduced urgency severity episodes in patients with OAB IUSS: Indevus Urgency Severity Scale Staskin D, et al. J Urol. 2007;178(3 pt 1):978-983.

  42. Antimuscarinics and Warning Time in OAB: Impact of Urgency First study to demonstrate significant increase in warning time in a large clinical setting (VENUS) (n = 739; solifenacin vs placebo)1 • Warning time: • Time from first sensation of urgency to voiding1-3 • Increase in warning time significant to patients1-3: • More time to reach a toilet • Avoid urge incontinence episodes • Other warning time placebo-controlled studies: • Darifenacin 15 mg daily (P = not significant; N = 432)2 • Darifenacin 30 mg daily (P = 0.003; N = 67)3 • Oxybutynin 2.5 mg TID (P < 0.001; N = 44)4 * Median change in warning time from baseline (seconds) (n = 372) (n = 367) (5-10 mg daily) * P = 0.032 Primary end point: mean reduction in urgency episodes per 24 hours: 3.91 for solifenacin vs 2.73 for placebo (P < 0.001) 1Toglia M, et al. Neurourol Urodyn. 2006;25:655. Abstract 123. 2Zinner N, et al. Int J Clin Pract. 2006;60:119-126. 3Cardozo L, et al. J Urol. 2005;173:1214-1218. 4Wang AC, et al. Urology. 2006;68:999-1004.

  43. Optimizing Treatment Success: Using Flexible-Dosing Options

  44. 48% Solifenacin 10 mg Solifenacin 5 mg (n = 578) Higher dose (10 mg) available 51% Tolterodine ER 4 mg + placebo Tolterodine ER 4 mg (n = 599) Higher dose not available Start 4 weeks 12 weeks OAB Patients Frequently Request Dose Adjustments Percent of patients requesting a dose increase at 4 weeks*1 • Similar results (59% vs 68%) were obtained after 2 weeks by a 12-week efficacy, safety, and tolerability study of darifenacin vs placebo2 * Prospective 12-week, parallel-group, double-dummy, 2-arm, double-blind, efficacy and safety study 1Chapple CR, et al. Eur Urol. 2005;48:464-470. 2Steers W, et al. BJU Int. 2005;95:580-586.

  45. † Antimuscarinic Flexible Dosing (1)STAR Study: Incontinent Patients Reporting No Incontinence Episodes at End Point on a 3-Day Diary* Incontinent patients reporting no incontinence episodes (%) Baseline (per 24 hours): 2.77 episodes 2.55 episodes * Patients who reported experiencing incontinence episodes per 24 hours at baseline and who did not report any episodes of incontinence for 3 consecutive days prior to the study visit † P = 0.006 vs tolterodine ER Chapple CR, et al. Eur Urol. 2005;48:464-470.

  46. Placebo Dose Escalation 0 mg 0 mg 7.5 mg 15 mg Antimuscarinic Flexible Dosing (2)Flexible-Dosing Study Reduction in incontinence episodes per week with darifenacin No Dose Escalation 7.5 mg 7.5 mg (n = 104) (n = 157) (n = 127) Median change from baseline (%) ■ 2 weeks ■ 12 weeks Steers W, et al. BJU Int. 2005;95:580-586.

  47. Antimuscarinic Flexible Dosing (3)Cumulative Response Rate With Increasing Dose Percent of patients N = 368 MacDiarmid SA, et al. J Urol. 2005;174(4 pt 1):1301-1305.

  48. Dosing Options Comparison * 1 hour before meal or on an empty stomach IR: immediate release TDS: transdermal delivery system Physicians’ Desk Reference. 62nd ed. Montvale, NJ: Thomson PDR; 2008.

  49. Tolterodine ER Oxybutynin ER Patients remaining persistent (%)1 Days Low Patient PersistenceMedicaid and Prescription Drug Databases Only 44% out of 1637 Medicaid patients remained persistent after 30 days • Low adherence and persistence reported by various clinical studies2-4: • Adherence rates reported for OAB similar to other chronic diseases5 • Low level of education and cultural and social support factors may contribute to poor compliance6 • Antimuscarinic therapy for OAB3,5-6: • Short- and long-term efficacy for significant proportion of users • Therapeutic/patient perceived benefits require at least 4-8 weeks of continuous therapy Persistence: time to discontinuation 1Adapted from Shaya FT, et al. Am J Manag Care. 2005;11(4 suppl):S121-S129. 2Chui MA, et al. Value Health. 2004;7:366. Abstract PUK11. 3Yu YF, et al. Value Health. 2005;8:495-505. 4Balkrishnan R, et al. J Urol. 2006;175(3 pt 1):1067-1071. 5Basra RK, et al. BJU Int. 2008. Epub ahead of print. 6Thomas L, et al. J Manag Care Pharm. 2008;14:381-386.

  50. Factors Affecting Adherence • Presentation and efficacy of medication • Cost (financial or personal) • Dosing frequency • Expectations of treatment • Route of administration of medication • Adequate follow-up after initiation of therapy Follow-up is important to ensure patient adherence to treatment Basra RK, et al. BJU Int. 2008. Epub ahead of print. D’Souza AO, et al. J Manag Care Pharm. 2008;14:291-301.

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