P2-10 COMBINED SHOCKWAVE THERAPY AND PLATELET-RICH PLASMA (COCKTAIL) FOR ERECTILE DYSFUNCTION–A PHASE II TRIAL EMPHASIZING SAFETY AND EFFICACY

• DOI: 10.1097/01.ju.0001015816.87470.c9.10
• Publication Date: 2024-05-03T09:00:31Z
• Authors: Braian R. Ledesma; Manuel Molina; Francesco Costant...; Francis Petrella; Russell Saltzman; Ranjith Ramasamy; David A. Velasquez

You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024P2-10 COMBINED SHOCKWAVE THERAPY AND PLATELET-RICH PLASMA (COCKTAIL) FOR ERECTILE DYSFUNCTION–A PHASE II TRIAL EMPHASIZING SAFETY EFFICACY Braian R. Ledesma, Manuel Molina, Francesco Costantini-Mesquita, Francis Petrella, Russell Saltzman, Ranjith Ramasamy, and David A. Velasquez LedesmaBraian Ledesma , MolinaManuel Molina Costantini-MesquitaFrancesco Costantini-Mesquita PetrellaFrancis Petrella SaltzmanRussell Saltzman RamasamyRanjith Ramasamy VelasquezDavid View All Author Informationhttps://doi.org/10.1097/01.JU.0001015816.87470.c9.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION OBJECTIVE: Therapeutic approaches focusing on tissue neovascularization play a crucial role the development treatments for erectile dysfunction (ED). Autologous Platelet-Rich Plasma (PRP) Low-Intensity Shockwave Therapy (SWT) are two restorative therapies that may target underlying causes ED. Pre-clinical evidence suggest their angiogenic regenerative properties, indicating potential synergistic pathway. We aim assess safety treatment efficacy combined PRP SWT men with mild or moderate ED, measured by International Index Erectile Function-EF (IIEF) questionnaire. METHODS: The COCKTAIL trial, single-center Phase study (NCT05048667), has enrolled 57 ED evaluated IIEF scores (12–25). Participants were randomized into group receiving PRP/SWT placebo saline/sham SWT. Patients received saline injections corpus cavernosum penile SWT/sham at set intervals. Evaluations included pain assessments, immediate follow-up examinations complications, scoring baseline, 3, 6 months. Penile doppler ultrasounds performed baseline adhered Institutional Review Board (IRB) approval data monitoring board. RESULTS: No adverse events (penile bruising, swelling, edema, allergy, fracture) observed either group. median 3 months, months 20.0, 21.0, 24.0, respectively. placebo/sham 18.0 19.0 18.5 There was no statistically significant change over time within Comparing both groups each time-point revealed differences average between (p=0.25), (p=0.14), (p=0.16). Interim analysis suggests is safe, though did not lead improvements function compared 6-month period observed. CONCLUSIONS: Initial findings indicate use yet its clinical treating be insignificant due small sample size. Further investigation larger cohorts necessary explore impact targeting Source Funding: Supported NIDDK grants R01 DK130991, UE5 DK137308, Clinician Scientist Development Grant from American Cancer Society RR © 2024 Urological Association Education Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5S2May 2024Page: e7 Advertisement Copyright & Permissions© Inc.Metrics Information More articles this author Expand PDF downloadLoading ...