Platelet-rich plasma (PRP) and platelet-rich fibrin matrix (PRFM) have gained interest in the last few years as a regenerative therapy for erectile dysfunction (ED). The present study aimed to systematically investigate the efficacy and safety of PRP/PRFM compared to a placebo for the management of ED. Adhering to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines, we systematically searched PubMed and Scopus from the database inception to February 2025. Randomized controlled trials (RCTs) investigating the International Index of Erectile Function (IIEF) score, sexual and overall satisfaction, peak systolic velocity (PSV) and end-diastolic velocity (EDV), and the complication rate of PRP/PRFM compared to placebo for men with ED were included. We included six RCTs, comprising 179 patients in the PRP/PRFM group and 180 in the placebo group. There was a notable variability in PRP/PRFM injection protocols. The analysis found that PRP/PRFM is associated with higher IIEF scores at ≥6 months of follow-up compared to placebo. Significant differences were also observed in the percentage of subjects attaining minimal clinically important differences of IIEF-Erectile Function from the first-month follow-up and in the Visual Analog Scale (VAS) scores post-injection, favoring the PRP/PRFM group. In contrast, sexual and overall satisfaction, PSV, and EDV were comparable. In the subgroup analysis, significant differences in IIEF scores compared to the placebo at the end of follow-up were noted only in the PRP group but not in the PRFM group. In conclusion, PRP and PRFM are well-tolerated, but PRP may yield superior results over PRFM compared to placebo, particularly after 6 months post-treatment. However, the results should be interpreted with caution due to small sample size, heterogeneity in protocols, and indirect comparison between PRP and PRFM. Further well-designed clinical trials are warranted.


Keywords: erectile dysfunction; meta-analysis; penile erection; platelet-rich fibrin; platelet-rich plasma