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Urgent Matters in OAB

Urgent Matters in OAB. An FAQ Approach to What You Need to Know Dr. Jeffrey M. Spodek , MD, FRCSC Division Head, Urology Rouge Valley Health System. Disclosures. I have served on Advisory Boards and received Consultant Fees from the following companies: Abbott Actavis Astellas

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Urgent Matters in OAB

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  1. Urgent Matters in OAB An FAQ Approach to What You Need to Know Dr. Jeffrey M. Spodek, MD, FRCSC Division Head, Urology Rouge Valley Health System

  2. Disclosures • I have served on Advisory Boards and received Consultant Fees from the following companies: • Abbott • Actavis • Astellas • Astra Zeneca • Eli Lily • GSK • Paladin • Pfizer • Sanofi • Triton

  3. Disclosure of Commercial Support • Potential for conflict(s) of interest: • Dr. Jeffrey M. Spodekhas received an honorarium from this event who does not make any products

  4. Today’s Program By the end of today’s session, participants will be able to: • Utilize key symptoms and patient screeners to recognize male and female OAB patients needing treatment, and identify patients who should be referred to a specialist • Differentiate between current treatment options, including antimuscarinics, and be confident in initiation of pharmacotherapy • Understand key criteria when individualizing treatment to patient needs

  5. WHAT IS YOUR CURRENT COMFORT LEVEL OF: LEARNING CHECKPOINT #1 Identifying patients with OAB needing treatment A Not comfortable at all B Somewhat comfortable C Comfortable D Very comfortable

  6. WHAT IS YOUR CURRENT COMFORT LEVEL OF: LEARNING CHECKPOINT #2 Differentiating and initiating antimuscarinics A Not comfortable at all B Somewhat comfortable C Comfortable D Very comfortable

  7. WHAT IS YOUR CURRENT KNOWLEDGE LEVEL OF: LEARNING CHECKPOINT #3 Beta-3 receptor agonists and future therapies in OAB management A Not knowledgeable at all B Somewhat knowledgeable C Knowledgeable D Very knowledgeable

  8. Your guide to tackling OAB in your office Overactive Bladder Overview Establishing an OAB diagnosis 30 Years of Antimuscarinic Therapy Beta-3 receptor agonists and future therapies in OAB management Wrapping it all up

  9. Clinical Definition of OAB “Urgency, with or without urgency incontinence, usually associated with frequency and nocturia” IDENTIFYING THE KEY SYMPTOMS OF OAB: Urgency: Sudden, compelling desire to void that is difficult to defer Urgency Incontinence: Involuntary loss of urine preceded by urgency Frequency: The need to frequently urinate (≥8 micturitions/24 hrs) Nocturia: Waking up ≥ 2 times at night to void Corcos J et al. Can J of Urol. 2006;13(3):3127-3138; Abrams P, et al. Neurourol 2002; 21: 167-178; Wein A et al. J Urol. 2006 Mar;175: :S5-S10; Corcos J, Schick E. Can J of Urology 2004; 11(3):2278-2284.

  10. What is Overactive Bladder? • OAB Mechanism Wein AJ, Rovner ES. Int J Fertil. 1999;44:56-66.

  11. “Urgency” drives OAB symptoms Adapted from Chapple CR et al BJU Int 2005; 95: 335-340

  12. Classifying OAB Dry OAB Wet OAB urgency, frequency without incontinence Mixed Incontinence urgency incontinence Involuntary leakage associated with urgency Considered a combination of stress and urge incontinence Proportion of OAB 38% Wet OAB 62% Dry OAB Stress incontinence is involuntary leakage associated with exertion, effort, sneezing or coughing Corcos J, Schick E. Can J of Urology 2004; 11(3):2278-2284; Kirby M, et al. Int J Clin Pract 2006; 60: 1263–127; Herschorn S, et al. BJU Int. 2008;101(1):52-58.; Irwin D, et al. EPIC Study. European Urology. 2006;50:1306-1314.

  13. OAB negatively impacts Canadians Effects more than 1 in 10 Canadians • Risk of falls/fractures • Economic burden • Emotional • Occupational • Physical 13.9% of Canadian respondents reported symptoms1 (13.1% of men and 14.7% of women) Impacts Quality of Life (QoL)2-5 • Sleep • Social • Sexual The effect of moderate urinary symptoms on QoL is similar to that of having diabetes, high blood pressure, or cancer6 1. Bettez M et al. Can Urol Assoc J 2012;6(5):354-63.; 2. Abrams P et al. Am J Manag Care 2000;6:S580–90; 3. Coyne KS et al. J Sex Med 2007;4:656–66; 4. Stewart WF et al. World J Urol 2003;20:327–36; 5. Brown JS et al. J Am Geriatr Soc 2000;48:721–5; 6. Robertson C et al. British Journal of Urology International. 2007;99:347-354.

  14. Similar Prevalence of OAB in Men and Women Stewart W et al. Prevalence of OAB in the US: results from the NOBLE program. Poster presented at WHO/ICI; July, 2001; Paris, France.

  15. OAB remains largely untreated Treated Untreated Total untreated (men and women) Number of patients: (7,244,501) (1,270,892) (543,420) (1,201,365) (755,218) (2,124,705) (1,348,901) 45–54 years 55–64 years ≥ 65 years • A large proportion of patients diagnosed with OAB are not taking medication • Men with OAB are more frequently untreated than women Helfand et al. Eur Urol 2010;57:586–591

  16. Your guide to tackling OAB in your office  Overactive Bladder Overview Establishing an OAB diagnosis 30 Years of Antimuscarinic Therapy Beta-3 receptor agonists and future therapies in OAB management Wrapping it all up

  17. ESTABLISHING AN OAB DIAGNOSIS How do I differentiate between similar conditions? How do I incorporate diagnosis into my practice? What are themost importantteststoestablish diagnosis? Are there specific considerations for males? Which “red flags” require referral to a specialist? Next Module

  18. OAB: A Secret Condition How do I incorporate diagnosis into my practice? • Do not always bring up symptoms • May be due to lack of knowledge (considered “a natural part of aging”) • May be due to embarrassment • Do not routinely ask about urinary symptoms If they do, 84% approach their primary care physician Welch LC et al. Res Nurs Health 2011;34(6):496-507.

  19. Simple Questions How do I incorporate diagnosis into my practice? Start the conversation by asking: • Do you have concerns with your bladder? • Do you experience frequency and/or urgency? • Do you ever lose urine if you do not make it to the bathroom in time? • Do you leak when you laugh/cough/squeeze/lift or strain? You can also have your patients complete the sentence “I hate my bladder because…”

  20. OAB Patient Screener How do I incorporate diagnosis into my practice? Patients can screen for OAB in the waiting room:

  21. ESTABLISHING AN OAB DIAGNOSIS How do I differentiate between similar conditions? How do I incorporate diagnosis into my practice? What are themost importantteststoestablish diagnosis? Are there specific considerations for males? Which “red flags” require referral to a specialist? Next Module

  22. Assess Patient History What are themost importanttests to establish diagnosis? Age(incidence increases with age) Prior surgery/ trauma Medical history (assess for medications that could cause symptoms) Association with other voiding and storage symptoms Lifestyle characteristics, including fluid intake Red Flags • Smoker with hematuria • History of complicated recurrent urinary tract infections • Severe symptoms of bladder outlet obstruction • Pain related to the bladder Duration and severity of symptoms Degree of bother/effect on activities of daily life 1. Bettez M et al. Can Urol Assoc J 2012;6(5):354-63

  23. Perform Physical Examination What are themost importanttests to establish diagnosis? Pelvic floor muscle assessment Abdominal, pelvic, and perineal examination Include digital rectal exam if appropriate Red Flags • Bladder/pelvic pain Cough test, if appropriate Use to differentiate stress urinary incontinence 1. Bettez M et al. Can Urol Assoc J 2012;6(5):354-63

  24. Appropriate Investigations What are themost importanttests to establish diagnosis? Standard recommendation: Urinalysis and culture • Optional: • Post-void residual urine (PVR) • PSA, if appropriate • Blood tests • If applicable co-morbidities are present (diabetes, etc.) • Assessment of renal function is not mandatory Red Flags • Hematuria (gross or macroscopic) • Elevated PVR (>200 cc)(assume palpable bladder) • Elevated PSA • Complicated positive urine culture 1. Bettez M et al. Can Urol Assoc J 2012;6(5):354-63

  25. ESTABLISHING AN OAB DIAGNOSIS How do I differentiate between similar conditions? How do I incorporate diagnosis into my practice? What are themost importantteststoestablish diagnosis? Are there specific considerations for males? Which “red flags” require referral to a specialist? Next Module

  26. Differentiating OAB from SUI and MI How do I differentiate between similar conditions? Kirby M, et al. Int J Clin Pract 2006; 60: 1263–127.

  27. Differential Diagnosis from Related Conditions How do I differentiate between similar conditions? REMINDER: OAB IS DEFINED AS“Urgency, with or without urgency incontinence, usually associated with frequency and nocturia” • * Timing of symptom onset usually very different • UTI being acute vs. OAB being chronic Nitti V, Taneja S. Int J Clin Pract. 2005;59:825-830; Nicolle LE Chapter 127, In: Hazzard’s Geriatric Medicine and Gerontology, 2011; Cornett PA, Dea TO. Chapter 39, In: CURRENT Medical Diagnosis & Treatment 2012, 2011; Prostate Cancer Canada Network: Prostate Cancer Symptoms; Prostate Cancer Cnada Network, Non-Cancerous Conditions: Benign Prostatic Hyperplasia.

  28. Additional Considerations How do I differentiate between similar conditions? OAB and Interstitial Cystitis Can present with similar symptoms (frequency, urgency, and negative cultures) Key differentiator: Pain Red Flags • Smoker with hematuria • History of complicated recurrent urinary tract infections • Severe symptoms of bladder outlet obstruction • Bladder/pelvic pain OAB and Prostate Cancer Can present with similar symptoms At risk group: older men, abnormal DRE, elevated PSA

  29. ESTABLISHING AN OAB DIAGNOSIS How do I differentiate between similar conditions? How do I incorporate diagnosis into my practice? What are themost importantteststoestablish diagnosis? Are there specific considerations for males? Which “red flags” require referral to a specialist? Next Module

  30. A Case of Mistaken Identity Are there specific considerations for males? Sees: a woman who describes LUTS Dr. thinks: Bladder Dr. treats: with Anti- muscarinics Sees: a man who describes LUTS Dr. thinks: Prostate Dr. treats: with Alpha- blockers ~50% of men with lower urinary tract symptoms do not have bladder outlet obstruction1 Many men may present with primary idiopathic OAB2 1. Chapple C et al. NICE Clinical Guideline. The management of lower urinary tract symptoms in men. May 2010; 2. Bettez M et al. Can Urol Assoc J 2012;6(5):354-63

  31. Lower Urinary Tract Symptoms in Men Are there specific considerations for males? Suggestive of OAB Suggestive of BOO/BPH However, OAB and BPH frequently co-exist 1. Chapple C et al. NICE Clinical Guideline. The management of lower urinary tract symptoms in men. May 2010; 2. Bettez M et al. Can Urol Assoc J 2012;6(5):354-63

  32. ESTABLISHING AN OAB DIAGNOSIS How do I differentiate between similar conditions? How do I incorporate diagnosis into my practice? What are themost importantteststoestablish diagnosis? Are there specific considerations for males? Which “red flags” require referral to a specialist? Next Module

  33. When referral is necessary: “Red Flags” • Consider bladder cancer if: • A smoker who with urgency, frequency, pain, and blood in the urine [painless hematuria (gross or microscopic)] • Urine cytology important for patient >40 yrs, smoker, risk factors for bladder cancer, and presence of hematuria • Consider prostate cancer if: • Abnormal DRE • Elevated PSA 1. Messing EM, et al. Campbell-Walsh Urology, 9th ed. Philadelphia: Saunders; 2007;2407-2446. 2. Nitti V, Taneja S. Int J Clin Pract. 2005; 59: 825-830. 3. Kelly CE, et al. Rev Urol. 2004;6(Suppl 1): S32–S37.; 4. Ouslander JG. Urology. 2002;60(5 Suppl 1):50-55

  34. When referral is necessary: “Red Flags” • Consider post-void residual volume (PVR) if: • Non-mobile elderly • Presence of neurological disease • History suggestive of outflow obstruction • Significant hesitancy and straining to void • Feeling of incomplete emptying (>200 mL) • Previous lower urinary tract surgery • Palpable bladder • A large PVR can be associated with UTIs, especially in persons at risk (children or patients with spinal cord injury or diabetes) • Very large PVRs (>400 mL) may be associated with an increased risk of renal insufficiency 1. Messing EM, et al. Campbell-Walsh Urology, 9th ed. Philadelphia: Saunders; 2007;2407-2446. 2. Nitti V, Taneja S. Int J Clin Pract. 2005; 59: 825-830. 3. Kelly CE, et al. Rev Urol. 2004;6(Suppl 1): S32–S37.; 4. Ouslander JG. Urology. 2002;60(5 Suppl 1):50-55

  35. ESTABLISHING AN OAB DIAGNOSIS How do I differentiate between similar conditions? How do I incorporate diagnosis into my practice? What are themost importantteststoestablish diagnosis? Are there specific considerations for males? Which “red flags” require referral to a specialist? Next Module

  36. Your guide to tackling OAB in your office  Overactive Bladder Overview  Establishing an OAB diagnosis 30 Years of Antimuscarinic Therapy Beta-3 receptor agonists and future therapies in OAB management Wrapping it all up

  37. Clinician’s OAB Toolbox • Oxybutynin • Oxybutynin IR • Oxybutynin ER • Oxybutynin CR • Oxybutynin patch • Oxybutynin gel • 5-HMT • Tolterodine IR • Tolterodine ER • Fesoterodine Select agent based on: • Patient and physician preference • Formulary and private coverage • Route and frequency of administration • Receptor and organ selectivity • Potential side effects • Efficacy Solifenacin Darifenacin Trospium chloride 1. Bettez M et al. Can Urol Assoc J 2012;6(5):354-63

  38. Provincial Public Drug Coverage (Restricted)* * Limited Use (Special Authorization/Exception drug status), after generic oxybutynin

  39. Goals of OAB Treatment Urgency and Frequency Voided volume Urgency incontinence(if applicable)

  40. 30 YEARS OF ANTIMUSCARINIC THERAPY Comparison of efficacy between products? What are the options for behavioural therapy? Are there pharmacological differences that impact tolerability? Can antimuscarinics be used in men? What is the efficacy & tolerability in special populations? Next Module

  41. Getting Your Patients On Board What are the options for behavioural therapy? Patient education is key to optimal treatment outcomes • Counseling patients on how to best incorporate strategies into their lives • Adherence to behavioural interventions • Optimal treatment outcomes Wyman JF et al. Int J Clin Pract. 2009;63(8):1177-91.

  42. Healthy Bladder Habits What are the options for behavioural therapy? Wyman JF et al. Int J Clin Pract. 2009;63(8):1177-91.

  43. Behavioural Modifications What are the options for behavioural therapy? Wyman JF et al. Int J Clin Pract. 2009;63(8):1177-91.

  44. 30 YEARS OF ANTIMUSCARINIC THERAPY Comparison of efficacy between products? What are the options for behavioural therapy? Are there pharmacological differences that impact tolerability? Can antimuscarinics be used in men? What is the efficacy & tolerability in special populations? Next Module

  45. Are there pharmacological differences that impact tolerability? Therapies Block Muscarinic Receptors in the Bladder Gillenwater JY, Grayhack JT, Howards, SS et al. Adult & Pediatric Urology (4th Edition). Philidelphia, PA: Lippincott Williams & Wilkins. 2002. M = muscarinicN = nicotinicα = α1 and α2 –adrenergic Β = β3-adrenergic Detrusor muscle (M2 80%; M3 20%; β) Mucosa and submucosa (M2, M3) Bladder neck (α) Pelvic floor (N) Urethra (α) Blocking receptors prevents detrusor contraction

  46. Are there pharmacological differences that impact tolerability? Abrams P., et al. Br J Pharmacol. 2006;148(5):565-578. Sellers DJ, et al. Curr Opin Urol. 2007;17:223-230. Muscarinic Receptors are Distributed Throughout the Body Blurred vision Iris/ciliary body Lacrimal gland Dry eyes Salivary glands Dry mouth Tachycardia Heart Stomach and esophagus Dyspepsia Constipation Colon Bladder (detrusor muscle) M1: Cortex, hippocampus, sympathetic ganglia M2: Hindbrain, heart, smooth muscle M3: Smooth muscle, brain, glands, heart, M4: Basal forebrain, striatum M5: Substantia nigra

  47. Are there pharmacological differences that impact tolerability? Antimuscarinic Agents Differ in Their Receptor and Organ Selectivity Antimuscarinics Agents Respective Product Monographs; Hashim H et al, Drugs 2004;64(15):1643-1656.; Chapple CR et al. BJU Int. 2006:98(supplement 1);78-87.

  48. Are there pharmacological differences that impact tolerability? Commonly Reported Side Effects with Antimuscarinics Respective Product Monographs. Solifenacin succinate is also available in a 10 mg dose. Darifenacin is also available in a 15 mg dose. Fesoterodine is also available in a 8 mg dose. Newer long-acting agents tend to have better tolerability compared to oxybutynin and immediate-release formulations

  49. 30 YEARS OF ANTIMUSCARINIC THERAPY Are there pharmacological differences that impact tolerability? Comparison of efficacy between products? What are the options for behavioural therapy? Can antimuscarinics be used in men? What is the efficacy & tolerability in special populations? Next Module

  50. Anticholinergics Effectively Reduce OAB Symptoms Buser et al. Eur Urol. 2012;62:1040-1060 Comparison of efficacy between products? Network meta-analysis comparing antimuscarinics in the treatment of OAB Mean reduction in micturitions/24h compared to placebo Solifenacin10 mg OxybutyninIR 15 mg OxybutyninIR 10 mg Fesoterodine8 mg Trospium chloride 40 mg Solifenacin5 mg Tolterodine ER 4 mg Oxybutynin gel Fesoterodine4 mg OxybutyninER 15 mg

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