Abstract
Abstract Introduction Platelet-rich plasma (PRP) intracorporeal injection is one of the popular regenerative therapies that has been gaining much interest in recent years as an adjunct or alternative treatment for erectile dysfunction (ED). Nevertheless, scientific evidence to support its clinical efficacy remains controversial. Objective The aim of this study was to evaluate the safety and efficacy of PRP injections for the treatment of ED. Methods A prospective, randomized, double-blinded, placebo-controlled, interventional clinical study was conducted on 52 subjects. Patients were randomized into two groups: the PRP group (n=26) and the placebo (saline) group (n=26). Each participant received three sessions (at two-week intervals) of PRP or saline injections according to his assigned group. International index of erectile function-5 (IIEF-5) scores and safety-related observations were collected during the 1st, 3rd, and 6th months of follow-up. Results The median age and ED duration were statistically comparable for both groups, 52.2 versus 52.5 years and 12.87 versus 11.8, respectively (P = 0.285). With regards to the efficacy of PRP, there were no statistically significant differences between both groups after 1, 3, and 6 months of treatment. After 1 month of treatment, the mean IIEF-5 score for the PRP group was 16.12 ± 1.25 versus 15.99 ± 1.21 for the placebo group (P = 0.683). After 3 months, the IIEF-5 score for the PRP group was 16.44 ± 1.17 compared to 16.31 ± 1.06 for the placebo group (P = 0.653). Also after 6 months, the IIEF-5 score for the PRP group was 16.35 ± 1.45 close to 16.23 ± 1.19 for the placebo group (P = 0.727). No transient hemorrhagic adverse events (hematuria, local petechial bleeding, or ecchymosis) or other side effects were reported during the injection and follow-up period for both groups. Conclusions The results of this trial suggest that although the treatment of ED with 3 injections of intracavernosal PRP separated by two-week intervals may be safe, it is not more effective than a placebo injection. Disclosure No.
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