The purpose of this study is to determine if treatment with Mirabegron will improve urinary urgency control beyond that achieved with pelvic floor exercises alone
A randomized 1:1 placebo controlled 10-week study of mirabegron as add-on therapy to an educational intervention on behavioral modification including pelvic floor exercise (BM-PFE) to a cohort of 40 Multiple Sclerosis (MS) subjects with overactive bladder (OAB). Trial will last approximately 12 weeks for each subject, including screening period and treatment period. Active drug will be mirabegron 25mg daily with optional up-titration to 50mg daily after approximately 5 weeks. Subjects will be randomized at the Baseline Visit based on recordings in a voiding diary kept for 72 continuous hours in the screening period. Voiding diaries of a 72 hour period each will be utilized during the screening period, between Phone Visit 1 and Titration and between Phone Visit 2 and Final Visit. In the diaries, subjects will record the time of each micturition and/or urgency episode, urine volume with each void (when available), any episode of incontinence, and the severity of urgency (Overactive Bladder Symptom Composite Score, mean of 72 hour total daily cumulative score. Primary outcome will be average daily OAB-SCS total score, Final Visit vs. Baseline. This accounts for the frequency, urgency and incontinence components of OAB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
see detailed information in associated Arm Description
Sugar pill manufactured to mimic Mirabegron 25mg tablet.
EvergreenHealth MS Center
Kirkland, Washington, United States
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit
Primary outcome: Overactive Bladder Symptom Composite Score (OAB-SCS) total score, average daily, Baseline vs. Final Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence. Higher values represent a worse outcome.
Time frame: 10 weeks
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit
Secondary Outcome Measure based on voiding diary: Average daily Overactive Bladder Symptom Composite Score (OAB-SCS) Baseline compared to Titration Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence. Higher values represent a worse outcome.
Time frame: 5 weeks
Mean # of Micturitions/Day Based on Voiding Diaries
Secondary Outcome Measure based on voiding diary: Baseline vs Final Visit: mean # of micturitions/day
Time frame: 10 weeks
Mean # of Incontinence Episodes/Day
Secondary Outcome Measure based on voiding diary: Baseline vs. Final Visit: Mean # of incontinence episodes/day
Time frame: 10 weeks
Mean Volume Voided/Micturition
Secondary Outcome Measure based on voiding diary: Baseline vs. Final Visit: Mean volume voided/micturition
Time frame: 10 weeks
Qualiveen Questionnaire
Secondary Outcome Measures based on the Qualiveen Questionnaire at Final Visit compared to Baseline Qualiveen questionaire is used, including 8 questions about aspects of bladder problems. Each question is rated 0 (not at all)- 4 (extremely). Overall score is averaged (average score per question)
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Time frame: 10 weeks
Subject Global Impression (Single Question)
Secondary Outcome Measures based on the Subject Global Impression (single question) at Final Visit compared to Baseline This is a single question: "How would you rate your level of bladder control during the past week?" 1-7 analog scale, 1 = "terrible'" 7 = "delighted."
Time frame: 10 weeks