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Potential Primary Endpoint for Exploratory Clinical Trial in Patients with Overactive Bladder: A Systematic Literature Review
Author(s) -
IINO Shingo,
KANEKO Masayuki,
NARUKAWA Mamoru
Publication year - 2018
Publication title -
luts: lower urinary tract symptoms
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.451
H-Index - 15
eISSN - 1757-5672
pISSN - 1757-5664
DOI - 10.1111/luts.12141
Subject(s) - urination , overactive bladder , medicine , placebo , clinical endpoint , urology , randomized controlled trial , clinical trial , surgery , urinary system , alternative medicine , pathology
Objectives To identify a potential primary endpoint in an early‐phase exploratory trial among key overactive bladder ( OAB ) symptoms. Methods Placebo‐controlled double‐blinding trials in patients with OAB were extracted for systematic literature review. The correlation between key OAB symptoms recorded in bladder diaries and coefficient of variation ( CV ) in each study were assessed. Results Forty‐one controlled trials were extracted for the present review. Mean number of urgency episodes in 24 h was substantially associated with mean number of urgency incontinence episodes in 24 h, mean volume voided per micturition, and mean number of micturitions in 24 h (Spearman's r = 0.725, −0.661, and 0.657, respectively). Mean number of micturitions in 24 h was also substantially associated with mean volume voided per micturition (Spearman's r = −0.674). Mean number of incontinence episodes in 24 h was substantially associated with mean number of urgency incontinence episodes in 24 h and mean volume voided per micturition (Spearman's r = 0.840 and −0.628, respectively). The median CV of mean volume voided per micturition in each trial was the smallest among all endpoints. Conclusions Our findings suggest that volume voided per micturition is a useful symptom for evaluating OAB candidate compounds in a small sample size and represents an effective primary endpoint, especially in exploratory clinical trials.