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

INTRODUCTION AND OBJECTIVE:

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 suggest 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 International Index of Erectile Function-EF (IIEF) questionnaire.

METHODS:

The COCKTAIL trial, a single-center Phase II study (NCT05048667), has enrolled 57 men with mild to moderate ED evaluated by IIEF scores (12–25). Participants were randomized into a treatment group receiving PRP/SWT or a placebo group receiving saline/sham SWT. Patients received PRP or saline injections in the corpus cavernosum and penile SWT/sham at set intervals. Evaluations included pain assessments, immediate and follow-up examinations for complications, and IIEF scoring at baseline, 3, and 6 months. Penile doppler ultrasounds were performed at baseline and 6 months. The study adhered to Institutional Review Board (IRB) approval and the data safety monitoring board.

RESULTS:

No adverse events (penile bruising, swelling, edema, allergy, or penile fracture) were observed in either group. The PRP/SWT median IIEF scores at baseline, 3 months, and 6 months were 20.0, 21.0, and 24.0, respectively. The placebo/sham group 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 placebo/sham group. Comparing both groups at each time-point revealed no statistically significant differences in average IIEF scores between the treatment group and the placebo group at baseline (p=0.25), 3 months (p=0.14), or 6 months (p=0.16). Interim analysis suggests that combined PRP and SWT is safe, though did not lead to statistically significant improvements in erectile function compared to placebo group over the 6-month period observed.

CONCLUSIONS:

Initial findings indicate that combined use of PRP and SWT is safe, yet its clinical efficacy in treating ED may be insignificant due to small sample size. Further investigation with larger cohorts is necessary to explore the potential efficacy of combined PRP/SWT and impact on clinical approaches targeting the underlying causes of ED.