Examining and safety and side effects of platelet-rich plasma versus placebo in a phase iii clinical trial in the management of erectile dysfunction

Abstract Introduction Restorative therapies are advertised as a cure for erectile dysfunction (ED) despite lack of data. One such therapy is platelet-rich plasma (PRP). PRP is created through centrifugation of autologous blood and separation of the platelet rich layer containing cytokines and growth factors involved in wound healing. We are conducting an ongoing, single center, prospective, one-to-one randomized, double blind, placebo controlled clinical trial assessing the safety and efficacy of PRP for ED (NCT04396795. Registered April 3, 2020). To reduce the variability in PRP concentration inherent to most PRP systems, we are using the Arthrex angel, the only system with an optical sensor to tailor PRP dose. Objective To assess the safety of injecting intracavernosal PRP in men with ED. Methods We retrospectively reviewed our clinical safety and adverse events data from September 2020 to May 2022. Patients receive either two injections of PRP or saline (placebo) four weeks apart. Patients were observed immediately post injection for adverse events. Additionally, patients were evaluated at 1-, 3- and 6-month periods. Finally, a Doppler ultrasound was completed at 6 months after last injection to assess for any structural or vascular changes to penis. For this analysis, we did not unblind patient groups. We report data from men who have received any injection with PRP or placebo and compared group A and B. We assessed statistical significance through t-test, where alpha=0.05. Results In total, 60 trial patients were included, 28 in group A and 32 in group B. There was no difference in pain with injection 1 (p=0.69) or injection two (p=0.99) (table 1). In each group, no major adverse events were recorded. In group A, only 1 minor adverse event, new penile plaque, was found (4.3%). This is similar to group B, where only 1 minor adverse event was reported (4.3%). No other minor adverse events were reported. Conclusions PRP appears safe to inject intracorporeally in patients with ED in our ongoing randomized placebo-controlled trial. Efficacy could not be assessed at this time. However, our study can help counsel patients on the side effects and complications associated with PRP. Disclosure No