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

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Presentation on theme: "Learning Objectives Accurately recognize overactive bladder (OAB), with urgency as the core symptom, in the context of other urinary symptoms that are."— Presentation transcript:

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. 1.True 2.False ?

3 Premeeting Survey Which of the following are NOT considered comorbidities in patients with OAB? 1.Falls and fractures 2.Urinary tract infections (UTIs) 3.Skin infections 4.Kidney stones ?

4 Premeeting Survey True or False: Using a flexible-dosing regimen of antimuscarinics results in improved efficacy and patient satisfaction. 1.True 2.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 dysfunction 1,2 Urgency, with or without urge incontinence, usually with frequency and nocturia 1,2 In absence of metabolic or pathologic conditions 1,2 1 Abrams 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 Urgency 1,2 Sudden compelling desire to pass urine that is difficult to defer Frequency 1,2 Patient considers that he/she voids too often by day Normal is < 8 times per 24 hours Nocturia 1,2 Waking to urinate during sleep hours Considered a clinical problem if frequency is greater than twice a night Urge urinary incontinence (UUI) 1 Involuntary leakage accompanied by or immediately preceded by urgency OAB wet 1,2 OAB with UUI OAB dry 2 OAB without UUI Warning time 3 Time from first sensation of urgency to voiding 1 Abrams P, et al. Neurourol Urodyn. 2002;21:167-178. 2 Wein AJ, et al. J Urol. 2006;175(3 pt 2):S5-S10. 3 Zinner N, et al. Int J Clin Pract. 2006;60:119-126.

8 Healthy Bladder Versus Overactive Bladder 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) 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 : Population-based prevalence studies: Comparison of data from the SIFO study (1997)* 1 and the EPIC study (2005) 2 1 Milsom I, et al. BJU Int. 2001;87:760-766. 2 Irwin DE, et al. Eur Urol. 2006;50:1306-1314. Prevalence (%) 0 5 10 15 20 25 30 35 40 Age (years) 18-2930-3435-3940-4445-4950-5455-5960-6465-69> 70 Men (SIFO 1997) Men (EPIC 2005) Women (SIFO 1997) Women ( EPIC 2005) 16.6 11.8 SIFO: Sifo/Gallup telephone survey * N = 16,776 interviews (6 European countries) N = 19,165 interviews (4 European countries and Canada) OAB Symptoms Are as Prevalent in Men as in Women and Increase With Age

10 Urgency Leading to Urgency Incontinence: More Prevalent in Women With UUI 55% With UUI 16% Without UUI 45% Without UUI 84% Women with OAB (n = 463) Men with OAB (n = 401) 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 Patients Suffer Needlessly From OAB 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 Khullar V, et al. Urology. 2006;68(2 suppl):38-48. Dmochowski RR, et al. Curr Med Res Opin. 2007;23:65-76. Patients Would Rather Cope With OAB Than Seek Help Due to:

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

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

15 Look for Comorbidities of OAB 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 Adapted from Darkow T, et al. Pharmacotherapy. 2005;25:511-519. 11,556 adult patients with OAB and 11,556 controls matched on propensity score P < 0.0001

16 1.I ask 1 or more questions like, Do you have urinary problems? 2.I let the patient bring it up 3.I use a questionnaire 4.I do not routinely ask about urinary problems ? How Do You Approach a Conversation About Urinary Problems Like OAB?

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? 1 Lavelle JP, et al. Am J Med. 2006;119(3 suppl 1):37-40. 2 Rosenberg MT, et al. Cleve Clin J Med. 2005;72:149-156.

18 How to Optimally Obtain a Patient History: Second Line of Questioning How are you handling your urinary symptoms? What is your most distressing symptom? How long have you experienced these symptoms? What is your fluid intake? What have you tried to solve your problems? Urgency Do you have to rush to go to the toilet? Do you have to urinate IMMEDIATELY? Frequency Do you feel that you urinate too often during the day? Nocturia Do you have to get up during the night to urinate? Is it the urge to urinate that wakes you? UUI When you feel the urge to urinate, do you have leaks or wetting accidents? 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: Carol Presentation 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? 1.Behavioral modifications 2.Pharmacotherapy 3.Combination of behavioral modifications and pharmacotherapy 4.I ask the patient for her treatment goals and preference first 5.I do not treat OAB ?

23 Behavioral Modifications Are a Good Starting Point Bladder training: scheduled voiding/voiding deferment 1,2 Pelvic floor exercises 1-4 : –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 alone 4 1 Christofi N, et al. Menopause Int. 2007;13:154-158. 2 Newman DK. Am J Nurs. 2002;102:36-45. 3 Burgio KL. J Am Acad Nurse Pract. 2004;16(10 suppl):4-7. 4 Milne JL. J Wound Ostomy Continence Nurs. 2008;35:93-101.

24 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=1093 1&nbr=005711&string=incontinence Strength of evidence: –Level A –Can be recommended as a noninvasive treatment in many women Clinical Practice Recommendation

25 Lifestyle Modifications in OAB: Current Evidence Is Sparse and Inconsistent Caffeine reduction dose dependent 1 : –Affects patients consuming 400 mg caffeine or 2.5 cups of coffee Weight loss 1 : –Significant reduction in UUI reported: No data in men or in OAB dry or moderately overweight patients Adjusting fluid intake 1,2 : –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 function 2 1 Milne JL. J Wound Ostomy Continence Nurs. 2008;35:93-101. 2 Newman DK, et al. Am J Nurs. 2002;102:36-45.

26 Case Study 1: Carol Treatment 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 Women UTI Bladder cancer Diabetes Multiple sclerosis SUI Recent pelvic surgery Neurogenic bladder Prolapse Urethral obstruction Atrophic vaginitis Postsurgical incontinence Rosenberg MT, et al. Cleve Clin J Med. 2007;74(suppl 3):S21-S29.

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

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

31 Treatment Goals for OAB Eliminate or improve UUI Reduce urgency - frequency - incontinence - nocturia Improvement in warning time Ensure treatment compliance for multiple long-term benefits: -Consider appropriate dose, comorbidities, cost, and improved QOL Consensus with the patients treatment expectations 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 Overall Expectations of Treatment 1 PhysiciansPatients Complete Cure3.2%17% Improved QOL85.9%43% Tailor to 2 : Environment Expectations Lifestyle Age Health 1 Robinson D, et al. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18:273-279. 2 Cardozo L. BJU Int. 2007;99(suppl 3):1-7. Not tailoring treatment may lead to 2 : Disillusionment Avoidable adverse events Unneeded use of time and resources Harmful and unnecessary surgery Morbidity/mortality Worsening symptoms

33 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 Clinical Practice Recommendation

34 Symptom-Based OAB Management 863 patients from 82 primary care and 16 obstetric/gynecology offices 1,2 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 1 Roberts R, et al. Int J Clin Pract. 2006;60:752-758. 2 Elinoff V, et al. Int J Clin Pract. 2006;60:745-751. * IMPACT: tolterodine extended release (ER) 12-week, open- label study 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)

35 Pros and Cons: Antimuscarinics PROSCONS Only approved treatments with grade A recommendation Physiology/uropharmacology still does not provide ideal agent Extensive literature has demonstrated efficacy and improved QOL Adherence to therapy is low Data available from large-scale, randomized controlled trials High placebo rates Alternative surgical treatments limited by morbidity and cost Response to behavioral therapies Good tolerabilityAnticholinergic side effects Adapted from Chapple C, et al. Eur Urol. 2008;54:226-230.

36 1 Steers WD. Urol Clin North Am. 2006;33:475-482. 2 Erdem N, et al. Am J Med. 2006;119(3 suppl 1):29-36. 3 Staskin DR. Drugs Aging. 2005;22:1013-1028. 4 Physicians Desk Reference. 62nd ed. Montvale, NJ: Thomson PDR; 2008. 5 Swart PJ, et al. Basic Clin Pharmacol Toxicol. 2006;99:33-36. * eg, paroxetine (SSRI) shares CYP2D6 liver metabolism with darifenacin eg, ketoconazole, fluoxetine (SSRI) SSRI: selective serotonin reuptake inhibitor Potential Adverse Events, Contraindications, and Drug Interactions of Antimuscarinics Most common side effects Dry mouth 1,2 Constipation 1,2 Blurred vision 1,2 Rare/potential adverse events Sedation, cognitive effects 2,3 Drowsiness, headache 4 Cardiac adverse effects (QT prolongation) 4 Heat prostration (decreased sweating) 4 Contraindications Urinary or gastric retention 4 Uncontrolled narrow-angle glaucoma 4 Drug interactions Antidepressants* 2,3 Polypharmacy in the elderly 2 CYP3A4 inhibitors 3,5 Diuretic effect of alcohol 2

37 Adverse Events Decline Over Time* Haab F, et al. BJU Int. 2006;98:1025-1032. 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

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

39 Outcome Measures 1.Objective versus subjective measures 2.Metrics for urgency: –Urgency severity –Warning time

40 Correlation of Subjective and Objective Measures Patient-Reported Outcomes (PROs) Tools Meaningful improvements for the patient Changes captured by PROs may differ and include more information than those captured by bladder diaries Bladder diaries OAB-q: – 8-item Symptom Bother scale – 25-item HRQOL scale (concern, sleep, social interaction, and coping) PPBC: – Single item of 6 statements Coyne KS, et al. Int J Clin Pract. 2008;62:925-931.

41 Staskin D, et al. J Urol. 2007;178(3 pt 1):978-983. Reduction in urgency severity score/void (IUSS) from baseline Metrics for Urgency: Reduction in Urgency Severity IUSS: Indevus Urgency Severity Scale Weeks P = 0.0002 P = 0.0008 P = 0.0004 (n = 292)(n = 300) –0.5 –0.4 –0.3 –0.2 –0.1 0 1412 Trospium 60 mg dailyPlacebo Trospium significantly reduced urgency severity episodes in patients with OAB

42 Warning time: –Time from first sensation of urgency to voiding 1-3 Increase in warning time significant to patients 1-3 : –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) (5-10 mg daily) (n = 372)(n = 367) First study to demonstrate significant increase in warning time in a large clinical setting (VENUS) (n = 739; solifenacin vs placebo) 1 * 1 Toglia M, et al. Neurourol Urodyn. 2006;25:655. Abstract 123. 2 Zinner N, et al. Int J Clin Pract. 2006;60:119-126. * 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) 3 Cardozo L, et al. J Urol. 2005;173:1214-1218. 4 Wang AC, et al. Urology. 2006;68:999-1004. Antimuscarinics and Warning Time in OAB: Impact of Urgency

43 Optimizing Treatment Success: Using Flexible-Dosing Options

44 OAB Patients Frequently Request Dose Adjustments 1 Chapple CR, et al. Eur Urol. 2005;48:464-470. 2 Steers W, et al. BJU Int. 2005;95:580-586. * Prospective 12-week, parallel-group, double-dummy, 2-arm, double-blind, efficacy and safety study Percent of patients requesting a dose increase at 4 weeks* 1 51% Tolterodine ER 4 mg + placebo Tolterodine ER 4 mg (n = 599) Higher dose not available 48% Solifenacin 5 mg (n = 578) Solifenacin 10 mg Higher dose (10 mg) available Start4 weeks 12 weeks Similar results (59% vs 68%) were obtained after 2 weeks by a 12-week efficacy, safety, and tolerability study of darifenacin vs placebo 2

45 Incontinent patients reporting no incontinence episodes (%) Chapple CR, et al. Eur Urol. 2005;48:464-470. P = 0.006 vs tolterodine ER Antimuscarinic Flexible Dosing (1) STAR Study: Incontinent Patients Reporting No Incontinence Episodes at End Point on a 3-Day Diary* 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

46 7.5 mg15 mg Dose Escalation 7.5 mg No Dose Escalation Median change from baseline (%) (n = 104)(n = 157) Reduction in incontinence episodes per week with darifenacin Steers W, et al. BJU Int. 2005;95:580-586. 0 mg Placebo (n = 127) Antimuscarinic Flexible Dosing (2) Flexible-Dosing Study 2 weeks 12 weeks

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

48 Dosing Options Comparison AntimuscarinicDosingDose Adjustment? Darifenacin 7.5 and 15 mg DailyYES Oxybutynin IR 5 mg BID, TID, QIDNO ER 5, 10, 15 mg Daily (up to 30 mg/day)YES TDS 3.9 mg/day system New patch twice a week (every 3-4 days) NO Solifenacin 5 and 10 mg DailyYES Tolterodine ER 4 mg DailyNO Trospium chloride* 20 mg 60 mg BID Daily NO Physicians Desk Reference. 62nd ed. Montvale, NJ: Thomson PDR; 2008. * 1 hour before meal or on an empty stomach IR: immediate release TDS: transdermal delivery system

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

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 Basra RK, et al. BJU Int. 2008. Epub ahead of print. DSouza AO, et al. J Manag Care Pharm. 2008;14:291-301. Follow-up is important to ensure patient adherence to treatment

51 OAB in Male Patients

52 Case Study 2: Tom Presentation Tom, aged 60 years, presents to your office for his annual physical examination At the end of the examination, he asks about the definition of normal voiding: –Works at night –Frequent bathroom visits interrupt his work –Slow urine stream and feeling that bladder has not emptied completely Unremarkable medical history and physical examination: –Checked blood sugar levels Normal laboratory values

53 Differential Diagnosis of Symptoms in Men With OAB Men Benign prostatic hyperplasia (BPH) Prostate cancer Diabetes Postsurgical incontinence Bladder outlet obstruction (BOO) Urethral stricture Neurogenic bladder Bladder stones Rosenberg MT, et al. Cleve Clin J Med. 2007;74(suppl 3):S21-S29.

54 Men With OAB: LUTS Storage and Voiding Symptoms Storage 1,2 (afferent, irritative) Voiding 1,2 (efferent/obstructive) Postmicturition 1,2 Urgency Frequency Nocturia UUI SUI MUI Overflow incontinence Hesitancy Poor flow/weak stream Intermittency Straining to pass urine Terminal dribble Prolonged micturition Urinary retention Postvoid dribble Sense of incomplete emptying 1 Abrams P, et al. Neurourol Urodyn. 2002;21:167-178. 2 Chapple CR, et al. Eur Urol. 2006;49:651-658.

55 Clinical Algorithm for the Management of LUTS in Men LUTS Focused history and physical examination Urinalysis/PSA Blood sugar Desires treatment Trial α-blocker Continue medication Watchful waiting Effective Ineffective Provisional OABProvisional BPH < 50 cc 50-200 cc> 200 cc Referral Check PVR No Referral and/or treat Unlikely BPH or OAB Rosenberg MT, et al. Int J Clin Pract. 2007;61:1535-1546. PSA: prostate-specific antigen PVR: postvoid residual

56 Clinical Algorithm for the Management of LUTS in Men (Cont.) Optional Titrate α -blocker Switch medication Try ARI, combination therapy Refer Uroflow High Low HighLow Antimuscarinics < 50 cc 50-200 cc > 200 cc Referral Continue therapy Referral Continue medication Effective Ineffective Effective Possible OAB Mixed OAB/BPH Diagnosis unclear Check PVR ARI: α-reductase inhibitor Rosenberg MT, et al. Int J Clin Pract. 2007;61:1535-1546.

57 Low Risk of Retention in Men on Antimuscarinics for OAB/LUTS Evidence From Trials Study/GoalResultReference(s) Antimuscarinic monotherapy in men with BOO/DO versus placebo No clinically meaningful change in PVR or urinary retention Abrams P, et al. J Urol. 2006;175(3 pt 1):999-1004. (Tolterodine ER) Combined therapy: α-blocker plus antimuscarinics in men Increased benefit with combination therapy Low incidence of retention Varying results for PVR increase Kaplan SA, et al. JAMA. 2006;296:2319-2328. (Tolterodine ER plus tamsulosin) Lee K-S, et al. J Urol. 2005;174(4 pt 1):1334-1338. (Propiverine hydrochloride* plus doxazosin ER) Antimuscarinic therapy in men with OAB with or without BPH medication Low incidence of retention, no catheterization Staskin DR, et al. Int J Clin Pract. 2008;62:27-38. (Oxybutynin TDS) * Not available in the United States DO: detrusor overactivity

58 Within the past month, do you feel that you had enough time to get to the bathroom? Global assessment of OAB severity OAB Symptom Improvement in Men: Patient-Reported Outcomes Antimuscarinic treatment effective and well tolerated in men with OAB: –Regardless of history of prostate condition Staskin DR, et al. Int J Clin Pract. 2008;62:27-38. Percent of male respondents Baseline Month Baseline Month Percent of male respondents N = 369 men with PPBC 4 (condition caused moderate, severe, or many severe problems) PPBC = 1, 2, or 3 PPBC = 4, 5, or 6 Always Most of the time Sometimes, infrequently, or never MATRIX: open-label study with oxybutynin TDS

59 Case Study 2: Tom Treatment and Follow-Up You use a questionnaire to assess Toms symptoms Behavioral modifications You start him on an α-blocker: –At follow-up, obstruction has improved He still complains of nocturia and you add antimuscarinic treatment: –After 4 weeks of antimuscarinic treatment, his nocturia episodes have been reduced to 2 times a night

60 Summary OAB is a prevalent disease that increases with age OAB impacts comorbidities and QOL OAB symptoms can be treated: –Move toward symptom/syndrome-based treatment –Individualized to match patients preference and expectations (tolerability and efficacy) –Recognize comorbidities and treatment fluid imbalances –Institute behavioral changes and pelvic floor exercises –Flexible-dosing regimens

61 Postmeeting Survey True or false: The core symptom of OAB is urgency. 1.True 2.False ?

62 Postmeeting Survey Which of the following are NOT considered comorbidities in patients with OAB? 1.Falls and fractures 2.UTIs 3.Skin infections 4.Kidney stones ?

63 Postmeeting Survey True or False: Using a flexible-dosing regimen of antimuscarinics results in improved efficacy and patient satisfaction. 1.True 2.False ?

64 Generic/Brand Name Table GenericTrade DarifenacinEnablex ® DoxazosinCardura ® FluoxetineProzac ®, Sarafem ® KetoconazoleExtina ®, Nizoral ®, Xolegel ® OxybutyninDitropan ®, Oxytrol ® ParoxetinePaxil ®, Pexeva ® PropiverineNot available in the United States SolifenacinVESIcare ® TolterodineDetrol ® TrospiumSanctura XR


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