Angle or Patient? Underutilization of Patient‐Reported Measures in Peyronie's Disease Randomized Controlled Trials
Abstract
Peyronie's disease significantly affects sexual function and psychological well‐being. It can lead to penile curvature, erectile dysfunction, and psychological distress—making the evaluation of quality of life through patient‐reported outcomes (PROs) essential. Therefore, this study sought to (1) describe the characteristics of RCTs evaluating therapies for PD, (2) assess the frequency and type of PROs employed across these studies, and (3) evaluate predictors associated with PRO inclusion. This was a retrospective, cross‐sectional study of ClinicalTrials.gov, evaluating all RCTs tagged with “Peyronie's Disease” from inception to 2024. Study characteristics including design, funding source, sample size, duration, and phase were extracted. Primary outcome types and all PRO measures were catalogued. Logistic regression was used to evaluate PRO usage. A total of 42 RCTs were identified, of which 54.8% were completed and 28.6% were industry‐sponsored. Most trials were interventional (81.0%) and had medium sample sizes (11–50 participants) with a mean duration of 640 days. Penile curvature was the most used primary endpoint (40.5%), while only 21.4% of trials used patient‐reported outcomes as the sole primary outcome. The Peyronie's Disease Questionnaire (PDQ) and International Index of Erectile Function (IIEF) were the most frequently reported PRO instruments. Trends in PRO usage varied by year, with inconsistent adoption across trials and no statistically significant predictors of PRO use identified in univariate analysis. PROs remain inconsistently used and are often treated as secondary to anatomical correction in Peyronie's disease randomized controlled trials. The high proportion of industry‐sponsored studies reflects ongoing innovation in therapeutic development, yet with insufficient emphasis on patient‐centered evaluation. Absence of consistent predictors for PRO utilization suggests a fragmented and non‐standardized approach to outcomes reporting, reinforcing the need for consensus‐driven, validated metrics in future trials.