A prospective, randomized, controlled, multicenter study of naftopidil for treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia: 75 mg once daily in the evening compared to 25 mg thrice daily.

INTRODUCTION: We examined the tolerability of dosage methods of naftopidil in the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH/male LUTS). PATIENTS AND METHODS: A total of 80 patients with BPH/male LUTS who had an International Prostate Symptom Score (IPSS) >or=8 and IPSS quality of life (QoL) >or=2 were enrolled and randomly administered naftopidil for 8 weeks at either 75 mg once daily (OD) in the evening (group O; n = 41) or 25 mg thrice daily (TID) in the morning, afternoon and evening (group T; n = 39).
RESULTS: IPSS total score, IPSS-QoL and BPH impact index (BII) were significantly improved for both groups at 8 weeks after starting treatment compared to baseline. IPSS total score and daytime and 24-hour voiding frequencies were significantly improved at 8 weeks after starting treatment for group O in comparison to group T. Group O showed a significantly better degree of change in BII in comparison to group T.
CONCLUSIONS: Naftopidil 75 mg OD in the evening was better tolerated than naftopidil 25 mg TID for the objective parameter and BII. Copyright (c) 2010 S. Karger AG, Basel.

RCT Entities:   Population Interventions Outcomes