(116) COMBINED SHOCKWAVE THERAPY AND PLATELET-RICH PLASMA (COCKTAIL) FOR ERECTILE DYSFUNCTION–A PHASE II TRIAL EMPHASIZING SAFETY AND EFFICACY
Authors: Costantini Mesquita F , Velasquez D , Ledesma B , Petrella F , Saltzman R , Ramasamy R , Molina M , Ibrahim E 
Published: December 2024

Abstract

Introduction
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 may target underlying causes of ED. Pre-clinical evidence suggests their angiogenic and regenerative properties, indicating a potential synergistic pathway. We aim to assess the safety and treatment efficacy of combined PRP and SWT in men with mild or moderate ED, measured by the International Index of Erectile Function-EF (IIEF) questionnaire.

Objective
The primary objective of this study is to evaluate the safety and efficacy of a combined PRP and SWT treatment regimen in men with mild to moderate ED. Specifically, we aim to determine if this combination therapy can significantly improve erectile function as measured by the IIEF scores over a period of six months.

Methods
The COCKTAIL trial, a single-center Phase II study, enrolled 57 men with mild to moderate ED, as evaluated by IIEF scores (12–25). Participants were randomized into two groups: a treatment group receiving PRP/SWT and a placebo group receiving saline/sham SWT. The treatment group received PRP injections in the corpus cavernosum and penile SWT at set intervals, while the placebo group received saline injections and sham SWT. Evaluations included pain assessments, immediate and follow-up examinations for complications, and IIEF scoring at baseline, 3 months, and 6 months. Additionally, penile Doppler ultrasounds were performed at baseline and 6 months to assess changes in penile blood flow. The study adhered to Institutional Review Board (IRB) approval and the data safety monitoring board guidelines to ensure participant safety and data integrity.

Results
The trial reported no adverse events such as penile bruising, swelling, edema, allergic reactions, or penile fractures in either the treatment or placebo groups. The median IIEF scores for the PRP/SWT group were 20.0 at baseline, 21.0 at 3 months, and 24.0 at 6 months. For the placebo/sham group, the median IIEF scores were 18.0 at baseline, 19.0 at 3 months, and 18.5 at 6 months. There was no statistically significant change over time within the treatment group or the placebo/sham group. Comparing both groups at each time point revealed no statistically significant differences in average IIEF scores between the treatment and placebo groups at baseline (p = 0.25), 3 months (p = 0.14), or 6 months (p = 0.16). Thus, interim analysis suggests that combined PRP and SWT is safe, though it did not lead to statistically significant improvements in erectile function compared to the placebo group over the observed six-month period.

Conclusions
Initial findings indicate that the combined use of PRP and SWT is safe for treating ED, yet its clinical efficacy may be insignificant due to the small sample size. The lack of statistically significant improvement in erectile function suggests that while the treatment is non-harmful, its benefits are not conclusively proven within this study’s parameters. Further investigation with larger cohorts is necessary to explore the potential efficacy of combined PRP/SWT and its impact on clinical approaches targeting the underlying causes of ED.

Disclosure
No.