title: Potential Primary Endpoint for Exploratory Clinical Trial in Patients with Overactive Bladder: A Systematic Literature Review.
abstract: OBJECTIVE
  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.
authors: Department of Clinical Medicine (Pharmaceutical Medicine), Kitasato University Graduate School of Pharmaceutical Sciences, Tokyo, Japan.
authors: Shingo
authors: S
authors: Iino
authors: Department of Clinical Medicine (Pharmaceutical Medicine), Kitasato University Graduate School of Pharmaceutical Sciences, Tokyo, Japan.
authors: Masayuki
authors: M
authors: Kaneko
authors: Department of Clinical Medicine (Pharmaceutical Medicine), Kitasato University Graduate School of Pharmaceutical Sciences, Tokyo, Japan.
authors: Mamoru
authors: M
authors: Narukawa
mesh_terms: D023381:Endpoint Determination; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D063189:Symptom Assessment; D053201:Urinary Bladder, Overactive / Q000150:complications* / Q000188:drug therapy*; D053202:Urinary Incontinence, Urge / Q000209:etiology; D014554:Urination; D014556:Urine
keywords: endpoint; overactive bladder; randomized controlled trial; systematic literature review