Pd52-01 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

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II (PD52)1 May 2024PD52-01 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 David A. Velasquez, Braian R. Ledesma, Manuel Molina, Francesco Costantini-Mesquita, Christabel Egemba, Emad Ibrahim, Thomas Masterson, Nicholas A. Deebel, Sunwoo Han, Isildinha M. Reis, Russell Saltzman, and Ranjith Ramasamy David A. VelasquezDavid A. Velasquez , Braian R. LedesmaBraian R. Ledesma , Manuel MolinaManuel Molina , Francesco Costantini-MesquitaFrancesco Costantini-Mesquita , Christabel EgembaChristabel Egemba , Emad IbrahimEmad Ibrahim , Thomas MastersonThomas Masterson , Nicholas A. DeebelNicholas A. Deebel , Sunwoo HanSunwoo Han , Isildinha M. ReisIsildinha M. Reis , Russell SaltzmanRussell Saltzman , and Ranjith RamasamyRanjith Ramasamy View All Author Informationhttps://doi.org/10.1097/01.JU.0001009412.04863.1b.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Peyronie's Disease (PD) is a condition characterized by localized inflammation leading to the formation of fibrotic plaques within the penile tunica albuginea, resulting in penile curvature and painful erections. Existing therapeutic options are limited. Platelet-Rich Plasma (PRP) may be a promising alternative due to its potential to modulate inflammatory processes. However, few placebo-controlled clinical trials exploring PRP's impact for PD exist. This study investigates the safety and efficacy of PRP injections in PD. METHODS: We present an ongoing randomized, placebo-controlled, crossover study conducted at the University of Miami, aiming to evaluate the safety and potential benefits of intralesional PRP injections for PD. We have enrolled 52 subjects into two groups, PRP-placebo sequence (Group A) and placebo-PRP sequence (Group B). Each group receives two injections of PRP and two placebo injections (saline) over six months, with crossover at the midpoint. Immediate and follow-up assessments, including pain scale measurements, goniometer assessments, questionnaires, and curvature evaluations, were conducted at baseline, three months, and six months. RESULTS: Interim analysis of 28 subjects who have completed the study shows PRP's safety and potential efficacy. No minor or major adverse events, such as penile bruising, swelling, edema, allergy, or penile fracture were reported. We also observed a 25% reduction in curvature (median of 10-degree reduction, p=0.047) in Group A after six months compared to baseline. CONCLUSIONS: Preliminary data show that PRP injections as safe and potentially effective for PD. These findings, although from a limited sample with complete data, are noteworthy for the absence of adverse events. Current research with extended follow-up aims to clarify the long-term therapeutic role of PRP in PD. Download PPT Source of Funding: Supported by NIDDK grants R01 DK130991, UE5 DK137308, and Clinician Scientist Development Grant from American Cancer Society to RR © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1072 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information David A. Velasquez More articles by this author Braian R. Ledesma More articles by this author Manuel Molina More articles by this author Francesco Costantini-Mesquita More articles by this author Christabel Egemba More articles by this author Emad Ibrahim More articles by this author Thomas Masterson More articles by this author Nicholas A. Deebel More articles by this author Sunwoo Han More articles by this author Isildinha M. Reis More articles by this author Russell Saltzman More articles by this author Ranjith Ramasamy More articles by this author Expand All Advertisement PDF downloadLoading ...