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

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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.

Original languageEnglish (US)
Pages (from-to)811-815
Number of pages5
JournalUrology
Volume59
Issue number6
DOIs
StatePublished - 2002

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Urinary Retention
Prostatic Hyperplasia
Finasteride
Therapeutics
Placebos
Prostate
Safety
Incidence
Randomized Controlled Trials
Clinical Trials

ASJC Scopus subject areas

  • Urology

Cite this

@article{244633cd7bde48b48fdde717301f572d,
title = "Reporting of acute urinary retention in BPH treatment trials: Importance of patient follow-up after discontinuation and case definitions",
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.",
author = "Claus Roehrborn",
year = "2002",
doi = "10.1016/S0090-4295(02)01649-7",
language = "English (US)",
volume = "59",
pages = "811--815",
journal = "Urology",
issn = "0090-4295",
publisher = "Elsevier Inc.",
number = "6",

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T1 - Reporting of acute urinary retention in BPH treatment trials

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AU - Roehrborn, Claus

PY - 2002

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N2 - 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.

AB - 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.

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