OBJECTIVES: The aim of this study was to investigate the efficacy and safety of propiverine for overactive bladder (OAB) in Japanese patients. METHODS: In this multicentre, randomized, double-blind study, patients ≥ 20 years old with symptoms of OAB for ≥ 12 weeks were allocated to either propiverine (20 mg once daily) or placebo for 12 weeks. Efficacy and quality of life were assessed using a 7-day bladder diary, the OAB symptom score, and King's Health Questionnaire. Safety was mainly assessed by adverse events and the QTc interval. RESULTS:A total of 567 patients were allocated. Change in number of micturitions/24 h was significantly greater in the propiverine group than in the placebo group (-1.86 vs-1.36, P = 0.001). Compared to placebo, propiverine produced significant improvements in urgency, urgency incontinence, urine volume/micturition, and the OAB symptom score. Significant improvements in urgency, urgency incontinence, and micturition frequency were observed at the first 4 weeks of treatment. All nine domains of King's Health Questionnaire were improved more with propiverine than with placebo. Adverse effects with propiverine were mostly mild, and no patient developed QTc interval prolongation exceeding 500 ms. CONCLUSION:Propiverine is effective for Japanese OAB patients by improving their symptoms and quality of life with a predictable side-effect profile.
RCT Entities:
OBJECTIVES: The aim of this study was to investigate the efficacy and safety of propiverine for overactive bladder (OAB) in Japanese patients. METHODS: In this multicentre, randomized, double-blind study, patients ≥ 20 years old with symptoms of OAB for ≥ 12 weeks were allocated to either propiverine (20 mg once daily) or placebo for 12 weeks. Efficacy and quality of life were assessed using a 7-day bladder diary, the OAB symptom score, and King's Health Questionnaire. Safety was mainly assessed by adverse events and the QTc interval. RESULTS: A total of 567 patients were allocated. Change in number of micturitions/24 h was significantly greater in the propiverine group than in the placebo group (-1.86 vs-1.36, P = 0.001). Compared to placebo, propiverine produced significant improvements in urgency, urgency incontinence, urine volume/micturition, and the OAB symptom score. Significant improvements in urgency, urgency incontinence, and micturition frequency were observed at the first 4 weeks of treatment. All nine domains of King's Health Questionnaire were improved more with propiverine than with placebo. Adverse effects with propiverine were mostly mild, and no patient developed QTc interval prolongation exceeding 500 ms. CONCLUSION:Propiverine is effective for Japanese OABpatients by improving their symptoms and quality of life with a predictable side-effect profile.