(112) Efficacy and Safety of Platelet-Rich Plasma Injections for Peyronie’s Disease: A Randomized Double-Blind Placebo-Controlled Cross-Over StudyB Ledesma, M Molina, D Velasquez, R Ramasamy
- Reproductive Medicine
- Endocrinology, Diabetes and Metabolism
- Psychiatry and Mental health
Peyronie's Disease (PD) is currently treated with intralesional collagenase injection, the only FDA-approved medical therapy. Platelet-derived therapies, such as autologous platelet rich plasma (PRP), have shown potential in tissue regeneration. We are investigating the safety and efficacy of PRP in PD with an ongoing randomized, placebo-controlled, crossover study.
The objective of this study is to assess the safety and efficacy of autologous platelet-rich plasma (PRP) treatment in Peyronie's Disease (PD) through a randomized, placebo-controlled, crossover trial.
We analyzed data from an ongoing trial conducted between April 2021 and June 2023. Men with PD (write degrees/dorsal only etc) were randomly assigned to receive two 0.5 ml injections of PRP obtained using an autologous platelet separator (Arthrex Angel, Arthrex Inc.) or placebo directly into the dominant plaque, with a two-week interval between injections. Immediate post-procedure assessments included Visual Analogue Pain Scale, and follow-up evaluations focused on identifying complications. After three months, participants crossed over to the other treatment arm for two additional injections. Goniometer measurement assessments were performed prior to each crossover (NCT04512287). Related Samples Wilcoxon-Signed Rank test was used for dependent repeated groups, the serial measurements of degree of curvature at different time points for each patient within a specific group. Findings at p< 0.05 were considered statistically significant.
The analysis includes data from 29 men who completed all injections and the 6-month follow-up. No minor or major adverse events, such as penile bruising, swelling, edema, allergy, or penile fracture, were reported. Regarding efficacy, we observed a significant reduction in curvature after six months compared to baseline. The pretreatment median curvature was 40.0 (IQR: 15), the median post-treatment curvature 30.0 (IQR: 30) (p=0.014). Furthermore, we did not observe worsening of curvature in subsequent evaluations.
Our findings from our ongoing clinical trial suggest that PRP treatment for Peyronie's Disease is safe, with minimal adverse events reported. The preliminary efficacy data indicates a significant reduction in curvature after 2 injections each of placebo and PRP treatment compared to baseline. Nevertheless, study completion is necessary prior to reporting true efficacy data comparing PRP vs placebo.