(107) A PHASE 2 RANDOMIZED, PLACEBO-CONTROLLED CROSSOVER TRIAL TO EVALUATE SAFETY AND EFFICACY OF PLATELET-RICH PLASMA INJECTIONS FOR PEYRONIE’S DISEASE: CLINICAL TRIAL UPDATE
Authors: Costantini Mesquita F , Velasquez D , Ledesma B , Ibrahim E , Ramasamy R , Masterson T , Han S , M Reis I , Saltzman R , Molina M 
Published: December 2024

Introduction

Peyronie’s Disease (PD) is a medical condition characterized by localized inflammation in the penile tunica albuginea, leading to the formation of fibrotic plaques. These plaques cause penile curvature and painful erections, significantly impacting the quality of life for affected individuals. Current therapeutic options for PD are limited and often fail to provide comprehensive relief. Platelet-Rich Plasma (PRP) therapy has emerged as a potential alternative due to its ability to modulate inflammatory processes and promote tissue healing. Despite its promise, there is a paucity of placebo-controlled clinical trials assessing PRP’s effectiveness for PD. This study aims to address this gap by investigating the safety and efficacy of PRP injections in patients with PD.

Objective

The primary objective of this study is to evaluate the safety and therapeutic efficacy of intralesional PRP injections in patients with Peyronie’s Disease. By conducting a randomized, placebo-controlled trial, we aim to provide robust data on PRP’s potential benefits and adverse effects.

Methods

This study is a randomized, placebo-controlled, crossover trial conducted at the University of Miami. We have enrolled 52 subjects diagnosed with PD, who were randomly assigned to one of two groups: Group A (PRP-placebo sequence) and Group B (placebo-PRP sequence). Each subject receives two PRP injections and two placebo injections (saline) over a six-month period, with a crossover occurring at the midpoint. The study’s methodology includes a comprehensive assessment protocol, incorporating pain scale measurements, goniometer assessments for penile curvature, and patient-reported outcomes via questionnaires. Assessments are performed at baseline, three months, and six months to monitor changes and gather data on both immediate and long-term effects of the treatment.

Results

Interim analysis of 28 subjects who have completed the study thus far indicates that PRP injections are both safe and potentially effective for treating PD. Notably, no minor or major adverse events, such as penile bruising, swelling, edema, allergic reactions, or penile fractures, were reported, underscoring the safety profile of PRP therapy. Furthermore, a statistically significant reduction in penile curvature was observed in Group A, with a median reduction of 10 degrees (p = 0.047), equating to a 25% improvement from baseline after six months of treatment.

Conclusions

Preliminary findings from this ongoing study suggest that PRP injections are a safe and promising therapeutic option for Peyronie’s Disease. The absence of adverse events and the significant reduction in penile curvature highlight PRP’s potential efficacy. While these initial results are encouraging, they are derived from a limited sample size. Continued research with a larger cohort and extended follow-up is necessary to fully elucidate the long-term therapeutic role of PRP in managing PD. This study represents a critical step toward improving treatment options for individuals suffering from this debilitating condition.

Disclosure

No.