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

Crossover study
DOI: 10.1097/01.ju.0001009412.04863.1b.01 Publication Date: 2024-04-15T21:36:53Z
ABSTRACT
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 UPDATE David A. Velasquez, Braian R. Ledesma, Manuel Molina, Francesco Costantini-Mesquita, Christabel Egemba, Emad Ibrahim, Thomas Masterson, Nicholas Deebel, Sunwoo Han, Isildinha M. Reis, Russell Saltzman, and Ranjith Ramasamy VelasquezDavid Velasquez , LedesmaBraian Ledesma MolinaManuel Molina Costantini-MesquitaFrancesco Costantini-Mesquita EgembaChristabel Egemba IbrahimEmad Ibrahim MastersonThomas Masterson DeebelNicholas Deebel HanSunwoo Han ReisIsildinha Reis SaltzmanRussell Saltzman RamasamyRanjith View All Author Informationhttps://doi.org/10.1097/01.JU.0001009412.04863.1b.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION OBJECTIVE: Peyronie's Disease (PD) is a condition characterized by localized inflammation leading the formation fibrotic plaques within penile tunica albuginea, resulting in curvature painful erections. Existing therapeutic options are limited. Platelet-Rich Plasma (PRP) may be promising alternative due its potential modulate inflammatory processes. However, few placebo-controlled clinical trials exploring PRP's impact for PD exist. This study investigates safety efficacy PRP injections PD. METHODS: We present an ongoing randomized, placebo-controlled, crossover conducted at University Miami, aiming evaluate benefits intralesional enrolled 52 subjects into two groups, PRP-placebo sequence (Group A) placebo-PRP B). Each group receives placebo (saline) over six months, with midpoint. Immediate follow-up assessments, including pain scale measurements, goniometer questionnaires, evaluations, were baseline, three months. RESULTS: Interim analysis 28 who completed shows efficacy. No minor or major adverse events, such as bruising, swelling, edema, allergy, fracture reported. also observed 25% reduction (median 10-degree reduction, p=0.047) Group after months compared baseline. CONCLUSIONS: Preliminary data show that safe potentially effective These findings, although from limited sample complete data, noteworthy absence events. Current research extended aims clarify long-term role Download PPT Source Funding: Supported NIDDK grants R01 DK130991, UE5 DK137308, Clinician Scientist Development Grant American Cancer Society RR © 2024 Urological Association Education Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1072 Advertisement Copyright Permissions© Inc.Metrics Information More articles this author Expand PDF downloadLoading ...
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