Ultrasound-Guided Shockwave and PRP Therapy for Erectile Dysfunction: Phase II Trial on Safety & Efficacy

The COCKTAIL trial, a Phase II study, investigates the safety and efficacy of a combined therapy using Platelet-Rich Plasma (PRP) and Low-Intensity Shockwave Therapy (SWT) to treat erectile dysfunction (ED) by targeting tissue neovascularization. Both PRP and SWT have shown angiogenic and regenerative properties in pre-clinical studies, suggesting potential synergy. In this trial, 57 men with mild to moderate ED (scored 12–25 on the International Index of Erectile Function-EF, IIEF) were randomly assigned to receive either PRP/SWT or a placebo (saline/sham SWT). Patients underwent PRP or saline injections into the corpus cavernosum, followed by SWT or sham treatment at specified intervals. Evaluations included pain assessment, complication checks, and IIEF scoring at baseline, 3 months, and 6 months. Additionally, penile Doppler ultrasounds were conducted at baseline and the 6-month mark. The study adhered to Institutional Review Board (IRB) protocols, with oversight from a data safety monitoring board. Findings showed no adverse events such as bruising, swelling, edema, or other complications in either group. Median IIEF scores for the PRP/SWT group were 20.0 at baseline, 21.0 at 3 months, and 24.0 at 6 months, whereas the placebo/sham group recorded scores of 18.0, 19.0, and 18.5, respectively. Although PRP/SWT demonstrated no statistically significant improvement over the placebo in erectile function, interim analysis confirms its safety. Researchers concluded that while the combined PRP and SWT approach appears safe, its effectiveness remains unclear, possibly due to the small sample size. Further studies with larger participant groups are recommended to better understand the potential of PRP/SWT in addressing ED.