Combo of shockwave therapy and platelet rich plasma safe for ED, but efficacy is unclear

Combining shockwave therapy (SWT) and platelet rich plasma (PRP) is safe for the treatment of patients with erectile dysfunction (ED); however, it remains unclear if the combination provides an efficacy benefit, according to results from the phase 2 COCKTAIL trial (NCT05048667) presented at the 2024 AUA Annual Meeting.¹

“Further investigations with larger cohorts are necessary to explore the potential efficacy of PRP/SWT and its potential impact on clinical approaches targeting the underlying causes of ED,” concluded David A. Velasquez.

In the study, men with ED were randomized to the PRP/SWT combo or saline/sham SWT (placebo arm). Patient evaluations consisted of International Index Erectile Function (IIEF-EF) scoring, pain assessments, and immediate and follow-up examinations for complications at baseline, 3 months, and 6 months. Patients also received penile doppler ultrasounds at baseline and 6 months.

Presenting author David A. Velasquez, a 4th year medical student at the University of Chicago Pritzker School of Medicine, reported at the AUA meeting that there were no adverse events observed in either study arm over the 6-month evaluation period of the trial. Specifically, there were no incidents of penile bruising, swelling, edema, allergy, or penile fracture.

Efficacy results, as measured by IIEF-EF scores, showed that there was not a statistically significant change in scores over time within either study arm, and there was also not a statistically significant difference in scores between the study arms at any of the pre-set time points. Median IIEF scores at baseline, 3 months, and 6 months were 20.0 vs 18.0 (P = .25), 21.0 vs 19.0 (P = .14), and 24.0 vs 18.5 (P = .16) in the PRP/SWT vs placebo/sham groups, respectively.

“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,” said Velasquez.

Providing background for the study, Velasquez said, “Shockwave therapy involves administering low intensity shockwaves directly to the corpus cavernosum to induce microtrauma and stimulate angiogenesis to promote better penile blood flow.” He added that, “Platelet rich plasma, in a similar fashion, involves the patient's own platelets, which have a concentration of growth factors and cytokines, injected back into the corpus cavernosum to stimulate better erectile function.”

Numerous studies have examined these treatments as monotherapies, but this is the first study to combine the therapies. “We believe [the combo] could potentially help patients with mild to moderate erectile dysfunction through physiological mechanisms, such as wound healing, tissue regeneration, and vascular remodeling,” said Velasquez.

The study enrolled male patients aged 30 to 80 years who, based on their IIEF-EF scores, were diagnosed with moderate ED (score of 12-21) or mild ED (score of 22-25). Patients who were taking PDE5 inhibitors at enrollment were allowed to continue the treatment.

Individuals were not eligible to enroll in the study if they had any prior penile surgery, such as penile plication, penile lengthening, grating, or penile cancer surgery; had a history of priapism, penile fracture, Peyronie’s disease, or penile curvature that negatively impacts sexual activity; had abnormal morning serum testosterone level (<300 ng/dL); had used anti-platelet medication; or had prior treatment failures with PDE5 inhibitors for ED.

The study included 56 patients with a median age of 55 years (interquartile range [IQR], 47-62) and a median BMI of 28.6 (IQR, 26.6-30.9). Over three-fourths (76.8%) of patients were White, 14.3% were Black, and 1.8% were Asian. Race was unknown for 7.1% of patients. Ethnicity data showed that 57.1% of patients were Hispanic, 37.5% were non-Hispanic, and race was unknown for 5.4% of patients. Half (50%) of patients were married, 23.2% were single/never married, 17.9% were divorced, 1.8% were widowed, and 7.1% did not provide marital status.

“Further investigations with larger cohorts are necessary to explore the potential efficacy of PRP/SWT and its potential impact on clinical approaches targeting the underlying causes of ED,” concluded Velasquez.

Reference

1. Ledesma BR, Molina M, Costantini-Mesquita F, et al. Combined Shockwave Therapy and Platelet-Rich Plasma (COCKTAIL) for Erectile Dysfunction – A Phase II Trial Emphasizing Safety and Efficacy. Presented at: 2024 American Urological Association Annual Meeting. May 2-6, San Antonio, Texas. Abstract P2-10.