Outcome Measures and Inclusion/Exclusion Criteria in Benign Prostatic Hyperplasia Trials on ClinicalTrials.gov

Introduction:For benign prostatic hyperplasia, clinical trials help assess new medical and surgical treatment options. The U.S. National Library of Medicine maintains ClinicalTrials.gov to provide access to prospective trials on diseases. This study investigates registered benign prostatic hyperplasia trials to determine if there are widespread differences in outcome measures and study criteria. Methods:Interventional research with known study status on ClinicalTrials.gov identified by the keywords "benign prostatic hyperplasia" was examined. Inclusion/exclusion criteria, primary outcomes, secondary outcomes, study status, study enrollment, country of origin, and intervention category were studied. Results:Of the 411 studies identified, International Prostate Symptom Score was the most common study outcome and was the primary or secondary study outcome in 65% of trials. Maximum urinary flow was the second most common study outcome (40.1% of studies). No other outcomes were measured as the primary or secondary outcome for more than 30% of studies. The most common inclusion criteria were a minimum International Prostate Symptom Score (48.9%), maximum urinary flow (34.8%), and minimum prostate volume (25.8%). Among studies using a minimum International Prostate Symptom Score, 13 was the most common minimum (35.3%) and a range of 7-21 was noted. The most common maximum urinary flow for inclusion was 15 mL/s (78 trials). Conclusions:Among clinicals trials on benign prostatic hyperplasia registered on ClinicalTrials.gov, a majority of studies utilized International Prostate Symptom Score as a primary or secondary outcome. Unfortunately, there were major differences in the inclusion criteria; these dissimilarities between trials may limit comparability of results across trials.