This study presents preliminary findings from the PRePED trial, a randomized, double-blind controlled study aimed at evaluating the efficacy of platelet-rich plasma (PRP) for treating vasculogenic erectile dysfunction (ED) in patients unresponsive to phosphodiesterase type 5 inhibitors (PDE5i). PRP, derived from the patient’s own blood and rich in platelets, has been proposed as a treatment for ED, though evidence supporting its effectiveness remains conflicted. In this trial, 27 patients with moderate to severe ED were randomized to receive six weekly intracavernous injections of either PRP (13 patients) or control (14 patients). The primary outcome was the improvement in erectile function as measured by the International Index of Erectile Function-Erectile Function (IIEF-EF) score after 28 weeks. Secondary assessments included the Erectile Hardness Score (EHS), and Sexual Encounter Profile (SEP) questionnaires, as well as penile Doppler ultrasound.
The interim analysis of the first 27 participants revealed lower-than-expected response rates, raising concerns about the treatment’s efficacy. Furthermore, three patients developed plaques in the tunica albuginea during follow-up, indicating a potential risk for adverse events. Due to these findings, a futility and safety analysis will be conducted, and the Data Safety Monitoring Board (DSMB) will decide whether to continue or terminate the trial early. These initial results suggest that PRP may not be an effective treatment for moderate to severe vasculogenic ED, and its association with plaque formation further questions its safety. Final conclusions regarding the efficacy and safety of PRP in this context will be made public at a later date.
