Platelet-rich plasma (PRP) improves erectile function: A double-blind, randomized, placebo-controlled clinical trial

Abstract

ABSTRACT Introduction Animal studies postulate that platelet-rich plasma (PRP) injections improve key elements of the pathophysiologic mechanisms leading to erectile dysfunction (ED). Objectives To conduct the first double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of PRP injections in patients with mild and moderate ED. Methods Sixty sexually active patients with mild and moderate ED were randomly assigned to two sessions, with a one-month difference, of 10 mL PRP (n=30) or placebo (n=30) intracavernosal injections. An FDA-approved separation system was used. Patients were evaluated at one, three and six months after completion of the treatment protocol. A per-protocol analysis was applied. All participants withheld any ED treatment during the trial. The primary outcome was the achievement of minimal clinically important difference (MCID) in the International Index of Erectile Function – Erectile Domain (IIEF-EF) from baseline to six months after final treatment. Erectile function at all time points, as well as safety of PRP injections, were also evaluated. Results At six months, a MCID was achieved by 20/29 (69%) patients in the PRP group compared to 7/26 (27%) in the placebo group. The risk difference between the two groups was 42% (95%CI: 18-66), p<0.001 and the baseline-adjusted mean between-group-difference in the IIEF-EF score was 3.9 points (95%CI: 1.8-5.9). Similarly, a statistically significant difference of both the number of participants attaining a MCID and the IIEF-EF score was also observed at the one- and three-month evaluation between the two groups. Accordingly, patients receiving PRP were more satisfied with the treatment. No adverse events were observed during the study period. Conclusions Intracavernosal PRP injection therapy used as outlined in this trial appears to be a safe and effective short-term treatment for the management of mild to moderate ED. Therefore, it may be a promising addition to the urologist's armamentarium for the management of ED. Still, further high-quality studies are warranted to corroborate our findings. Disclosure Work supported by industry: no.