Introduction: Our goal was to assess the safely and efficacy of two injections of platelet rich plasma (PRP) for treating mild to moderate erectile dysfunction (ED) by conducting a prospective, randomized, placebo controlled, double blind, clinical trial. Methods: Men with mild to moderate erectile dysfunction (international index of erectile function scores 11-25) were randomized to receive either two injections of PRP or placebo separated by 1 month. Primary outcome was change in IIEF score and percentage of men meeting minimum clinically important difference (MCID) at 1 month. Secondary outcomes were changes in penile vascular parameters and adverse events. Results: We randomized 61 men: 28 into PRP and 33 into placebo. We had complete 1 month data for 24 men receiving PRP and 28 receiving placebo. At one month, IIIEF-EF score changed from 17.4 (95% CI-15.8 to 19.0) to 21 (17.9-24.0) in men receiving PRP, vs 18.6 (17.3-19.8) to 21.6 (19.1-24.1) in the placebo, however there was no difference detected (P=0.756). There was no difference in percentage of men meeting MCID: A total of 14 (58.3%) in PRP group compared to 15(53.6%) in placebo. There were no differences in adverse events, and importantly, there were no serious adverse events. There were no differences in mean penile Doppler parameters between baseline at 1 month, or between PRP and placebo. Conclusions: The result of our prospective, double-blind, randomized, placebo-controlled clinical trial suggest that two injections of intracavernosal PRP separated by one month in men with mild to moderate ED is safe, however similar in efficacy as compared to placebo. Our study represents the first of its kind in the United States to evaluate efficacy of PRP as a treatment option for ED. This will hopefully impact management of providers as PRP injections is a widely advertised and used therapy for ED both within and outside Urology, across all states, both in private practices as well in a variety of Men's Health Clinics. SOURCE OF Funding: N/A
