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

Urology. 2002 Jun;59(6):811-5. doi: 10.1016/s0090-4295(02)01649-7.

Abstract

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.

Publication types

  • Review

MeSH terms

  • Acute Disease
  • Adrenergic alpha-Antagonists / therapeutic use*
  • Enzyme Inhibitors / therapeutic use*
  • Finasteride / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Prostatic Hyperplasia / drug therapy*
  • Randomized Controlled Trials as Topic
  • Urinary Retention / epidemiology*
  • Urinary Retention / etiology

Substances

  • Adrenergic alpha-Antagonists
  • Enzyme Inhibitors
  • Finasteride