PRP injections for erectile dysfunction show similar efficacy as placebo

A prospective, randomized, double-blind, placebo-controlled trial found that platelet-rich plasma (PRP) injections are safe but with similar efficacy to that of placebo in the treatment of mild to moderate erectile dysfunction (ED).

The findings, which were simultaneously presented at the 2023 American Urological Association Annual Meeting in Chicago, Illinois, and published in the Journal of Urology, were presented by Brian Ledesma, MD, andrology research fellow at the University of Miami in Florida.^1,2

For the study, men with mild to moderate ED (International Index of Erectile Function-Erectile Function domain [IIEF-EF] scores 11-25) were randomly assigned to receive either 2 injections of PRP or placebo, separated by 1 month. The primary outcome was change in IIEF-EF score as well as percentage of men meeting minimum clinically important difference at 3 and 6 months. Secondary outcomes included changes in penile vascular parameters and adverse events (AEs) at 3 and 6 months.

A total of 61 men were included in the study, 28 of whom received PRP injections and 33 of whom received placebo. The investigators reported that no differences in baseline demographics or characteristics between men in the treatment arm vs placebo, with the exception that more in the placebo group were prediabetic compared with the PRP group despite having similar median A1c levels. On a scale of 1 to 10, mean pain with injection 1 was 3.7 for patients in the PRP arm vs 3.5 in the placebo arm, and mean pain with injection 2 was 4.1 for the PRP arm vs 4 in the placebo arm.

The investigators reported that at 1 month, IIEF-EF score changed from 17.4 (95% CI, 15.8-19.0) to 21 (95% CI, 17.9-24.0) for men receiving PRP injections compared with 18.6 (95% CI, 17.3-19.8) to 21.6 (95% CI, 19.1-24.1) in the placebo group. The difference between groups was not statistically significant (P = .756).

There were no major (defined as grade 3 or higher) AEs in either arm, and 1 minor (grade 1 or 2) AE in each arm. One patient in the placebo group (3.0%) experienced hematoma and 1 patient (3.6%) in the PRP arm developed new plaque. In addition, there was no difference in the percentage of men meeting minimum clinically important difference in the PRP group compared with the placebo group. “There were no changes in penile Doppler parameters from baseline to 6 months,” the authors reported in their Journal of Urology paper.

Ranjith Ramasamy, MD

“What we found was the IIEF[-EF] scores actually improved in the men that received the PRP, but was no different in the improvement in the men that received the sham. So really, PRP does not seem to be effective in treating men with erectile dysfunction, at least as a monotherapy,” senior author Ranjith Ramasamy, MD, told Urology Times. Ramasamy is an associate professor of clinical urology and the director of Male Reproductive Medicine and Surgery at the Desai Sethi Urology Institute at the University of Miami in Florida.

“I think maybe future studies can look at PRP for select patient populations, but at least in men with mild to moderate ED, with several different underlying diagnoses, we think PRP doesn't make a big difference,” Ramasamy added.

References

1. Ledesma B, Masterson T, Molina M, Zucker I, Ibrahim E, Ramasamy R. Platelet rich plasma for the treatment of erectile dysfunction: a prospective, randomized, double blind, placebo controlled clinical trial. Presented at: American Urological Association Annual Meeting, April 28-May 1, Chicago. Abstract LBA01-12

2. Masterson TA, Molina M, Ledesma B, et al. Platelet-rich plasma for the treatment of erectile dysfunction: a prospective, randomized, double-blind, placebo-controlled clinical trial. J Urol. Published online April 30, 2023. Accessed April 30, 2023. doi:10.1097/JU.0000000000003481