(151) Safety and Feasibility of the COCKTAIL (Combining Shockwave Therapy and Platelet-Rich Plasma for Erectile Dysfunction) Trial: A Single Center, Randomized, Double-Blind, Sham-Controlled Study UpdateBR Ledesma, DA Velasquez, C Egemba, R Saltzman, M Molina, F Costantini, E Ibrahim, T Masterson, R Ramasamy
- Reproductive Medicine
- Endocrinology, Diabetes and Metabolism
- Psychiatry and Mental health
Therapeutic approaches focusing on tissue neovascularization play a crucial role in the development of treatments for erectile dysfunction (ED). Autologous Platelet-Rich Plasma (PRP) and Low-Intensity Shockwave Therapy (SWT) are two restorative therapies that potentially target underlying causes of ED. Pre-clinical evidence suggests their angiogenic and regenerative properties, indicating a potential synergistic pathway to improve vasculogenic ED.
The primary objective aims to investigate and compare the treatment efficacy of PRP injection and SWT vs placebo injection/SHAM treatment in men with mild-moderate ED, as measured by IIEF. The secondary objective aims to study incidence of adverse events and safety of PRP injection and SWT treatment in men with mild-moderate ED, as measured by IIEF.
The COCKTAIL (Combining Shockwave Therapy and Platelet Rich Plasma) trial is a Phase II, single-center study assessing the safety and efficacy of PRP and SWT in combination for ED (NCT05048667). Thirty-five men with mild to moderate ED were enrolled based on International Index of Erectile Function-EF subdomain (IIEF-EF) questionnaire (12-25). Data from a cohort of men treated with PRP and SWT were analyzed, comparing it to men who received placebo saline injections and sham SWT. Patients received two PRP or placebo injections directly into the corpus cavernosum and penile SWT every week for 5 weeks. Assessment included pain scale evaluations, immediate post-procedure examination, and follow-up for complications. IIEF scores were recorded at baseline, 3-month, and 6-month follow-up visits. All statistics and analyses were conducted with IBM SPSS Statistics 27.0.1. Non-parametric tests were used for analysis. Mann-Whitney U test was used to compare independent groups (Group A vs. Group B) at different time points. Related Samples Wilcoxon -Signed Rank test was used for dependent repeated groups, the serial measurements of IIEF-EF scores at different time points for each patient within a specific group. Findings at p< 0.05 were considered statistically significant.
The primary endpoint of this study was to investigate the incidence of Serious Adverse Events (SAEs). Encouragingly, no adverse events were reported, suggesting that the procedure appears to be safe for the participants. The median baseline IIEF scores for patients in Group A were 17 (±4), and at the three-month follow-up, the scores increased to 19 (±4), slightly dropping to 18 (±8) at six months. In Group B, the median baseline IIEF scores were 19.50 (±4), which improved to 20 (±7) at the three-month follow-up and further increased to 21 (±10) at six months. No statistical differences were found likely because this is an ongoing study, and we only have complete data for 12 men. We aim to accrue a total of 30 men in each arm and plan to complete the recruitment by January 2024 and complete the study by July 2024. Currently, both the investigators and the patients remain blinded.
The combination of PRP and SWT appears to be safe, as no adverse events were reported. Although preliminary data do not show differences between the treatment and sham groups currently, we intend to complete the trial to perform a comprehensive statistical calculation for efficacy.