A multicenter, double-blind, placebo-controlled trial of the efficacy of prazosin in the treatment of dysuria associated with benign prostatic hypertrophy.

An 8-center, double-blind, placebo-controlled trial of 39 patients with benign prostatic hypertrophy was conducted to assess the effects of prazosin HCl treatment on functional urologic variables after a treatment period of 4 weeks. The randomized groups were comparable for demographic variables and symptoms, except for the mean residual urinary volume, which was significantly higher in the prazosin HCl group. Prazosin HCl elicited statistically significant improvements in the mean prostatic urethral pressure and prostate area (Mann-Whitney U test: p = 0.001 for both variables as compared with the placebo group). Functional bladder capacity also improved significantly in the group receiving the test drug (Mann-Whitney U test: p = 0.05, as compared with the placebo group). Clinical improvements were also observed in the mean maximum urinary flow, decreased nocturia frequency, and residual urinary volume. Patient preference significantly favored the prazosin HCl treatment (Mann-Whitney U test: p = 0.001). Seven patients on prazosin HCl and 5 receiving placebo reported one or more side effects during the trial phase; these were mild to moderate and disappeared or were tolerated. No statistically significant effects on blood pressure or heart rate were observed.