Effect on Urapidil on Benign Prostatic Hypertrophy: A Multicenter, Double-Blind Study

Abstract

In a prospective multicentric double-blind trial, urapidil, an α₁-adrenergic antagonist, was investigated for its efficacy in benign prostatic hypertrophy (BPH). After 1 week of baseline on placebo, 214 patients with BPH were randomly assigned to 4 groups; group P was given placebo, group L, 15 mg of urapidil b.i.d. for 3 weeks, group M, 15 mg b.i.d. for 1 week followed by 30 mg b.i.d. for 2 weeks, and group H, 15 mg b.i.d. for 1 week followed by 45 mg b.i.d. for 2 weeks. In all groups, day and night urinary frequency improved significantly (p < 0.01 or p < 0.05) compared to baseline, but the differences were not significant between groups. The residual urine rate was significantly (p < 0.05 vs. group P) decreased in group H. Average and maximum flow rate improved significantly (p < 0.01 or p < 0.05) in group M and group H, but intergroup differences were not noted. Overall impression evaluated by investigators improved significantly (p < 0.01 vs. group P) in group M and group H. More patients in group H (7/55) and group M (4/51) had side effects than in group P (2/54). None of them were severe. In summary, a daily dosage of 60 mg urapidil proved to be the most beneficial in the treatment of patients with BPH.

Clinical guideline for male lower urinary tract symptoms

“…79 The efficacy of urapidil for neurogenic bladder has also been confirmed in a placebo-controlled RCT.…”

“…Urapidil significantly improved residual urine and maximum flow rates than placebo in an RCT on BPH. 79 The efficacy of urapidil for neurogenic bladder has also been confirmed in a placebo-controlled RCT. 80…”

A Multicenter Placebo-Controlled, Double-Blind Trial of Urapidil, an &alpha;-Blocker, on Neurogenic Bladder Dysfunction

“…Urapidil, a newly synthesized α 1 -blocker, was demonstrated to be an effective agent for voiding dysfunction due to benign prostatic hyperplasia in a placebo-controlled trial [15]. Among α 1 -blockers, such as prazosin, bunazosin and terazosin, urapidil has a high proportion of α 2 /α 1 , α 2 -blocking activity corresponding to 1/8 that of yohimbine [16].…”

Comparison of prazosin, terazosin and tamsulosin in the treatment of symptomatic benign prostatic hyperplasia: A short‐term open, randomized multicenter study

“…Since prazosin was first introduced and was proved to be effective in improving symptoms caused by BPH, 1 a number of alpha‐1 blockers have been explored for the medical treatment of BPH. The alpha‐1 blockers which have been approved in Japan for clinical use for the treatment of BPH are prazosin, 2 tamsulosin, 3 terazosin, 4 urapidil, 5 and naftopidil. 6 Presently, however, very little information is available on the differences between these alpha‐1 blockers in their efficacy and safety profiles in the treatment of BPH.…”