MP36-10 SAFETY AND FEASIBILITY OF PLATELET-RICH PLASMA INJECTIONS FOR PEYRONIE DISEASE: A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED CROSS-OVER STUDY

Abstract

You have accessJournal of UrologyCME1 Apr 2023MP36-10 SAFETY AND FEASIBILITY OF PLATELET-RICH PLASMA INJECTIONS FOR PEYRONIE DISEASE: A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED CROSS-OVER STUDY Braian Ledesma, Manuel Molina, Kevin Chu, Thomas Masterson, Isaac Zucker, Emad Ibrahim, and Ranjith Ramasamy Braian LedesmaBraian Ledesma More articles by this author , Manuel MolinaManuel Molina More articles by this author , Kevin ChuKevin Chu More articles by this author , Thomas MastersonThomas Masterson More articles by this author , Isaac ZuckerIsaac Zucker More articles by this author , Emad IbrahimEmad Ibrahim More articles by this author , and Ranjith RamasamyRanjith Ramasamy More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003270.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The only FDA-approved medical therapy for Peyronie’s Disease involves use of intralesional collagenase injection. Platelet-derived therapies have acquired increased popularity in different areas in medicine due to their potential ability in tissue regeneration. In PD, autologous platelet rich plasma (PRP) may be an emerging viable treatment. Our hypothesis is that PRP can be safely used in PD, with minimal adverse events. Therefore, we are conducting a randomized, placebo controlled, cross over study to test it. METHODS: We analyzed data of a cohort of men from the ongoing trial treated with PRP vs placebo at our center from Apr-2021 to Oct-2022. Patients received two 0.5 ml injections of PRP obtained using an autologous platelet separator (Arthrex Angel, Arthrex Inc.) or placebo directly into the dominant plaque, separated by two weeks. Patients were examined immediately after the procedure and assessed with Visual Analogue Pain Scale, and at follow-up for complications. Patients are then followed three-months post-injections, at which point they cross over into the other treatment arm for two more injections. Patients undergo goniometer measurement, IIEF-15 and PDQ questionnaire assessment, prior to crossover. (NCT04512287) RESULTS: We report data from the 29 men who completed all injections. No minor or major adverse events such as penile bruising, swelling, edema, allergy, or penile fracture were reported. No patients experienced complications at follow-up. No worsening curvature was seen in men at later evaluations. CONCLUSIONS: From our data accumulated thus far in our ongoing randomized placebo-controlled trial with PRP for PD, PRP appears to be a safe and feasible treatment modality. Our study is the first one in the USA evaluating men with PRP for PD and we believe data from our study will be important for evaluating PRP as an additional medical treatment modality for PD. Source of Funding: This work was supported by NIH Grant R01 DK130991 and Clinician Scientist Development Grant from the ACS to RR, as well as SMSNA Research Grant to KC © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e483 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Braian Ledesma More articles by this author Manuel Molina More articles by this author Kevin Chu More articles by this author Thomas Masterson More articles by this author Isaac Zucker More articles by this author Emad Ibrahim More articles by this author Ranjith Ramasamy More articles by this author Expand All Advertisement PDF downloadLoading ...