Reporting of acute urinary retention in BPH treatment trials: importance of patient follow-up after discontinuation and case definitions.

OBJECTIVES: A growing number of reports of retrospective analyses of adverse events occurring during studies with alpha-blockers in men with benign prostatic hyperplasia (BPH) have compared acute urinary retention (AUR) event rates with placebo-controlled finasteride trials. Because of differences in study designs, the present analysis was undertaken to compare data on the rates of AUR across different BPH trials accurately.
METHODS: We report the incidence of spontaneous AUR for placebo, finasteride, and alpha-blockers based on published data in randomized clinical trials in men with BPH.
RESULTS: On the basis of the data from all published randomized finasteride and alpha-blocker studies reporting AUR, the overall incidence rate for spontaneous AUR during active treatment with placebo, alpha-blockers, and finasteride ranged from 0.9 to 5.2, 0 to 1.2, and 0.3 to 1.2, respectively. The only study to provide data on AUR occurring during post-treatment follow-up was the Proscar Long-Term Efficacy and Safety Study (PLESS), in which approximately 25% of events occurred in patients after they had discontinued the study. Several of the alpha-blocker studies had significantly shorter durations, relatively small patient populations with smaller prostate volumes, lower numbers of events reported, and higher discontinuation rates with no follow-up, all of which could tremendously affect the reporting of AUR. Additionally, only PLESS reported on both spontaneous and precipitated AUR.
CONCLUSIONS: Simply comparing the reported rates of AUR from published studies without taking into consideration spontaneous versus precipitated AUR, discontinuation rates, total patient follow-up, and prostate volume does not adequately allow for comparison of the true event rate across different clinical trials.