A Multicenter Placebo-Controlled, Double-Blind Trial of Urapidil, an α-Blocker, on Neurogenic Bladder DysfunctionYamanishi T.a · Yasuda K.b · Homma Y.c · Kawabe K.c · Morita T.d
Departments of Urology,aSchool of Medicine, Chiba University, Chiba, bDokkyo University School of Medicine, Koshigaya Hospital, cFaculty of Medicine, University of Tokyo, and dTokyo Medical and Dental University School of Medicine, Tokyo, Japan
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Objectives: To assess the efficacy of urapidil, an α-blocker, on neurogenic bladder dysfunction in a placebo-controlled, double-blind trial. Methods: 149 patients were randomly assigned to receive a placebo or 60 mg/day of urapidil for 4 weeks. The evaluation of efficacy included changes in urinary symptom scores and the results of a pressure/flow study. Results: There were significant intergroup differences with regard to straining and the sum of urinary symptom scores, with the urapidil group showing marked improvements (p = 0.016 and p = 0.011, respectively). In the urapidil group, the average and maximum flow rates were unchanged, but the residual urine volume decreased significantly (p < 0.001) as compared with the baseline value. The pressure at maximum flow and the minimum urethral resistance decreased significantly (p = 0.040 and p = 0.040, respectively) in the urapidil group, and there was a significant (p = 0.005) inter-group difference with regard to pressure at maximum flow. There was also a significant (p < 0.001) inter-group difference with regard to the overall therapeutic effect. Side effects were noted in 2 patients treated with urapidil and 6 in the placebo group. Conclusion: Urapidil is effective for the treatment of voiding dysfunction in patients with neurogenic bladder.
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