MP47-01 PRePED STUDY: A RANDOMISED, DOUBLE-BLIND CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF INTRACAVERNOSAL INFUSION OF PLATELET RICH PLASMA (PRP) AGAINST CONTROL (PLATELET POOR PLASMA) IN THE TREATMENT OF VASCULOGENIC ERECTILE DYSFUNCTION PRELIMINARY RESULTS

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy I (MP47)1 May 2024MP47-01 PRePED STUDY: A RANDOMISED, DOUBLE-BLIND CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF INTRACAVERNOSAL INFUSION OF PLATELET RICH PLASMA (PRP) AGAINST CONTROL (PLATELET POOR PLASMA) IN THE TREATMENT OF VASCULOGENIC ERECTILE DYSFUNCTION PRELIMINARY RESULTS Esaú Fernández Pascual, Raphael Curvo, Gustavo Centeno Soto, Claudio Martínez-Ballesteros, Jorge Turo Antona, Laura Prieto, Joaquín Carballido, Cristina Avendaño Solá, José Luis Bueno, and Juan Ignacio Martínez-Salamanca Esaú Fernández PascualEsaú Fernández Pascual , Raphael CurvoRaphael Curvo , Gustavo Centeno SotoGustavo Centeno Soto , Claudio Martínez-BallesterosClaudio Martínez-Ballesteros , Jorge Turo AntonaJorge Turo Antona , Laura PrietoLaura Prieto , Joaquín CarballidoJoaquín Carballido , Cristina Avendaño SoláCristina Avendaño Solá , José Luis BuenoJosé Luis Bueno , and Juan Ignacio Martínez-SalamancaJuan Ignacio Martínez-Salamanca View All Author Informationhttps://doi.org/10.1097/01.JU.0001008880.11564.10.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Platelet-rich plasma (PRP) is an autologous component derived from the patient's own blood, with a high concentration of platelets. There is conflicting evidence regarding the efficacy and safety of this preparation for the treatment of erectile dysfunction. The primary objective of this study is to evaluate the efficacy of intracavernous injection of PRP in the treatment of vascular erectile dysfunction in comparison to control measured by the improvement in the IIEF-EF score after 28 weeks. METHODS: PRePED is a randomized, double-blind controlled trial (NCT04502875) that compares the administration of 6 weekly injections of PRP versus control in patients with moderate or severe vasculogenic erectile dysfunction who are non-responders to PDE5i. PRP obtained by apheresis had a standard platelet mass for all patients of 10 uL/ml. Non-responders who have received control enter into a second phase to receive the PRP product. The IIEF-EF, EHS, SEP2 and SEP3 questionnaires, as well as a penile Doppler ultrasound, were used as efficacy tools. RESULTS: The results of the first 27 patients randomized in the study were analyzed (PRP, 13 patients; control, 14 patients). The mean age of the patients was 58.4 (SD 8.9) years. The interim analysis showed that the rate of responders was much lower than expected and additionally in three patients, plaques in the tunica albuginea were detected during the follow-up. Due to these facts, a futility and safety analysis will be performed and the opinion of the Data Safety Monitoring Board (DSMB) will be sought to decide about the early termination of the trial based on the conditional power of the study to achieve its primary outcome and the detected adverse event. The final results of efficacy and safety will be made public at the late-breaking abstract deadline. CONCLUSIONS: PRP does not appear to be an effective treatment for patients with moderate or severe ED, in addition to being associated with a risk of plaque formation in the tunica albuginea. Source of Funding: Ministry of Economy and Competitiveness and co-financed by FEDER funds, Instituto de Salud Carlos III, PI17/02001, Spanish Government © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e762 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Esaú Fernández Pascual More articles by this author Raphael Curvo More articles by this author Gustavo Centeno Soto More articles by this author Claudio Martínez-Ballesteros More articles by this author Jorge Turo Antona More articles by this author Laura Prieto More articles by this author Joaquín Carballido More articles by this author Cristina Avendaño Solá More articles by this author José Luis Bueno More articles by this author Juan Ignacio Martínez-Salamanca More articles by this author Expand All Advertisement PDF downloadLoading ...