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Measuring Urgency – End Points in Overactive Bladder (OAB) Syndrome

Norman Zinner, MD, MS, FACS Founder and Medical Director Western Clinical Research Torrance, California. Measuring Urgency – End Points in Overactive Bladder (OAB) Syndrome.

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Measuring Urgency – End Points in Overactive Bladder (OAB) Syndrome

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  1. Norman Zinner, MD, MS, FACSFounder and Medical DirectorWestern Clinical ResearchTorrance, California Measuring Urgency – End Points in Overactive Bladder (OAB) Syndrome

  2. OAB is defined as “urgency with or without urge incontinence, usually with frequency and nocturia” where urgency is defined as “ the complaint of a sudden compelling desire to pass urine that is difficult to defer” OAB: A Symptom Syndrome Urgency, “the complaint of a sudden compelling desire to pass urine that is difficult to defer”

  3. Potential Urgency Pathways Brain Spinal Tract Neurons PMC afferent nerve excitability central sensory processing myogenic process urothelial-afferent interactions Spinal Efferents Ganglia Bladder Ach PMC = pontine micturition center.

  4. How to Measure Urgency in OAB • Objective measurement of urgency is difficult • No previously validated scales • Verysubjective symptom • Metrics • Likert • Pain Scales Standardized/validated scales are needed! De Jong PR, et al. Annual Meeting of the International Continence Society, 2004.

  5. Measuring Urgency • A validated patient-reported measure of the event-specific severity of urinary urgency in the context of clinical trials Indevus Urgency Severity Scale (IUSS) Nixon A, et al. J Urol. 2005;174:604-607.

  6. Indevus Urgency Severity Scale: IUSS 4-point scale 0 1 2 3 Nixon A, et al. J Urol. 2005;174:604-607.

  7. Measuring Urgency: IUSS (Cont’d) • Validation with • Urinary frequency • Urinary incontinence (UI) episodes • Volume voided • Incontinence Impact Questionnaire (IIQ) scores • Construct/content validity • Test/retest • Responsiveness to change Nixon A, et al. J Urol. 2005;174:604-607.

  8. Using the IUSS to Evaluate Urgency Severity Study 2 Study 1 1 4 12 1 4 12 * * Mean Change in Urgency Severity Score/Void *** *** *** *** Weeks Weeks Placebo *P0.01.***P0.0001. Trospium For both studies, urgency severity scores at baseline were 1.8 for both placebo and trospium chloride. Zinner NR. Expert Opin Pharmacother. 2005;6:1409-1420.

  9. Changes From Baseline in IUSS by Baseline Quartiles 12 Weeks 0.1 0 * -0.1 Mean Change From Baseline in IUSS at Week 12 * -0.2 Placebo Trospium * -0.3 * -0.4 0 to 1.435 >1.435 to 1.522 >1.522 to 2.127 >2.127 to 3.0 Baseline IUSS Quartile Ranges *P<0.05. Sand P, Zinner N. Annual Meeting of the International Continence Society, 2005.

  10. Changes From Baseline in Percentage of Voids by IUSS Categories 12 Weeks 40 30 20 10 Change From Baseline to Week 12 in Percentage of Voids 0 -10 20 Placebo -30 Trospium -40 None Mild Moderate Severe IUSS Urgency Severity Category Sand P, Zinner N. Annual Meeting of the International Continence Society, 2005.

  11. IUSS Limitations • Urgency Severity Score may not fully describe the impact of thepatient urgency symptom • Individual learned or instructed behaviors decrease average urgency severity

  12. How would you measure an earthworm?

  13. The OAB Symptom Composite Score • Since no single parameter has been shown to determine the total impact of OAB on a patient, a scale (OAB-SCS) was developed to evaluate the sum of the major OAB symptoms • In this way, the suite of symptoms can be looked at together to more fully understand patient experience with treatment/treatment efficacy Zinner N, et al. J Urol. 2005;173:1639.

  14. OAB-SCS Components • Comprises common patient-reported diary data, including • 24-hour voiding frequency • Urgency severity (IUSS) associated with each toilet void • Frequency of UUI episodes • Examines the suite of symptoms together to more fully understand patient experience with treatment/treatment efficacy UUI = urgency urinary incontinence. Zinner N, et al. J Urol. 2005;173:1639.

  15. OAB Symptom Composite Score • 2 multicenter, randomized, controlled trials • Trospium chloride vs placebo • N=1157 (n=581 placebo; n=576 trospium) • Overactive bladder inclusion criteria • Patient diary data included as component (IUSS) Zinner N, et al. J Urol. 2005;173:1639.

  16. IUSS Values per Toilet Void and Corresponding OAB-SCS Points per Toilet Void or UUI Zinner N, et al. J Urol. 2005;173:1639.

  17. OAB-SCS Total for Patient-Reported Toilet Voids and UUI Events During 1 Day of Diary Collection Zinner N, et al. J Urol. 2005;173:1639.

  18. Baseline Distribution of OAB-SCS Values 30 25 20 Percentage of Patients 15 10 5 0 0 20 40 60 80 100 120 Baseline OAB-SCS Zinner N, et al. J Urol. 2005;173:1639.

  19. OAB-SCS Tertiles and Corresponding OAB Symptom Profile at Baseline Median OAB-SCS Tertile Zinner N, et al. J Urol. 2005;173:1639.

  20. Median Change From Baseline in OAB-SCS Week 1 Week 4 Week 12 Time Point 0 -2 n=577 Placebo -4 n=544 Trospium n=573*** Median Change From Baseline n=509 -6 -8 n=545*** n=500*** -10 ***P-value <0.0001 for treatment comparability from ANOVA. Zinner N, et al. J Urol. 2005;173:1639.

  21. OAB Symptom Composite Score • Provides a single quantifiable value to the overall number and severity of OAB symptoms • Accounts for the association of void frequency and urgency severity/void • Incorporates all incontinence events • Enables clinically relevant interpretations of therapeutic efficacy Zinner N, et al. J Urol. 2005;173:1639.

  22. IUSS: validated urgency measurement scale for evaluation of clinical efficacy OAB-SCS: clinically, easily interpretable composite score of 3 OAB symptoms Summary Additional scales necessary for accurate evaluation of treatment efficacy in OAB

  23. IUSS Values per Toilet Void and Corresponding OAB-SCS Points per Toilet Void or UUI Zinner N et al. J Urol. 2005;173:1639.

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