Current advances in platelet-rich plasma therapy for erectile dysfunction: a meta-analysis of randomized controlled trials

Abstract Introduction Erectile dysfunction (ED) is a prevalent condition with multifactorial etiology and significant impact on men’s quality of life. Although standard therapies—such as phosphodiesterase type 5 inhibitors, vacuum devices, and penile prostheses—offer symptomatic relief, they do not address the underlying pathophysiology. Platelet-rich plasma (PRP), an autologous concentration of platelets and growth factors, has emerged as a potential regenerative treatment that may promote neurovascular repair and restore erectile function. Aim To evaluate the efficacy and safety of PRP monotherapy for the treatment of erectile dysfunction through a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods Following PRISMA guidelines, a comprehensive search of PubMed, EMBASE, Google Scholar, Cochrane Library, Scopus, and Web of Science was performed for RCTs assessing intracavernosal PRP injections in men with ED. Studies combining PRP with other regenerative therapies were excluded. Data were synthesized using a random-effects model to generate pooled standardized mean differences (SMDs) in International Index of Erectile Function (IIEF) scores at 1, 3, and 6 months. Risk of bias was assessed using the Cochrane RoB 2 tool, and certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Results Seven RCTs including 512 participants were analyzed. PRP injection volumes ranged from 5 to 10 mL across 2-4 sessions. At 1 month, pooled SMD in IIEF was 0.28 (95% CI −0.11 to 0.67, P = .16); at 3 months, it was 0.29 (95% CI −0.08 to 0.67, P .05); and at 6 months, it was 0.36 (95% CI −0.09 to 0.81, P = .12). Heterogeneity was high (I2 = 74%-83%) across time points. Subgroup analyses showed no significant difference by risk of bias. PRP was well tolerated, with only isolated mild adverse events (hematoma, plaque formation) reported. Conclusion Current evidence does not support a consistent, clinically meaningful improvement in erectile function with PRP monotherapy compared with placebo. Despite an encouraging mechanistic rationale and safety profile, the high heterogeneity, small sample sizes, and methodological limitations of existing RCTs limit confidence in efficacy. Larger, standardized, double-blind trials with rigorous protocols are needed to clarify the role of PRP in ED management.