Potential Primary Endpoint for Exploratory Clinical Trial in Patients with Overactive Bladder: A Systematic Literature Review.
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.
['Iino|Shingo|S|', 'Kaneko|Masayuki|M|', 'Narukawa|Mamoru|M|']
D023381:Endpoint Determination D006801:Humans D016032:Randomized Controlled Trials as Topic D063189:Symptom Assessment D053201:Urinary Bladder, Overactive D053202:Urinary Incontinence, Urge D014554:Urination D014556:Urine
endpoint overactive bladder systematic literature review randomized controlled trial