Platelet-rich Plasma for the Treatment of Erectile Dysfunction: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial

Abstract

Purpose:We assessed the safety and efficacy of 2 injections of platelet-rich plasma for treating mild to moderate erectile dysfunction by conducting a prospective, randomized, double-blind, placebo-controlled clinical trial.Materials and Methods:Men with mild to moderate erectile dysfunction (International Index of Erectile Function scores 11-25) were randomized to receive either 2 injections of platelet-rich plasma or placebo separated by 1 month. Primary outcome was percentage of men meeting minimum clinically important difference at 1 month after the second injection. Secondary outcomes were change in International Index of Erectile Function at 1, 3, and 6 months, and changes in penile vascular parameters and adverse events at 6 months.Results:We randomized 61 men: 28 into platelet-rich plasma and 33 into placebo. There was no difference between groups in percentage of men meeting minimum clinically important difference at 1 month: 14 (58.3%) in platelet-rich plasma vs 15 (53.6%) in placebo (P = .730). Mean International Index of Erectile Function–Erectile Function domain changed from 17.4 (95% CI 15.8-19.0) to 21 (17.9-24.0) at 1 month in men receiving platelet-rich plasma, vs 18.6 (17.3-19.8) to 21.6 (19.1-24.1) in the placebo group; however, there was no significant difference between groups (P = .756). There were no major adverse events and only 1 minor adverse event in each group. There were no changes in penile Doppler parameters from baseline to 6 months.Conclusions:The results of our prospective, double-blind, randomized, placebo-controlled clinical trial suggest that 2 injections of intracavernosal platelet-rich plasma separated by 1 month in men with mild to moderate erectile dysfunction is safe, but we found no difference in efficacy between platelet-rich plasma and placebo.

Platelet-rich plasma therapy in erectile dysfunction and Peyronie’s disease: a systematic review of the literature

“…Sample was centrifugated at 1500 rpm for 15 min 5 mL of PRP injected into each corpora cavernosa at two different lateral sites, 1 cm distal to mid penile shaft through a 25 Gauge needle. A rubber band was applied around the penile root and removed 20 min after the injections Follow up time: 1 month Improvement of IIEF-5 score questionnaire (12 ± 2.6 vs. 19 ± 3.0; p < 0.0001) and PSV (32 ± 5.5 cm/s vs. 42 ± 7.6 cm/s; p < 0.0001) Mean platelet volume (MPV) has a significant accuracy in identifying men clinically responding to PRP with favorable outcomes 16 subjects experienced dull pain during injections and two patients reported a slight subcutaneous hematoma at the injection site the day after the procedure No randomized trial; no control group; single injection; short follow up Masterson [ 27 ] 2023 Prospective, randomized, double-blind, placebo-controlled trial 61 patients PRP group: 28 patients, median age 49 years ([IQR] 38.5–55). placebo group: 33 patients median age 46 years ([IQR] 42–56) Inclusion criteria: male patients aged 30–75 with organic ED (IIEF score 11–25) for > 6 months; normal testosterone; hemoglobin A1c < 9% Exclusion criteria: Patients using intracavernosal injection or urethral suppositories for ED treatment; PRP and saline solution group Autologous PRP analyzed by Arthrex Angel PRP system 2.5 mL of PRP, or saline solution, were injected into the right and left corpus cavernosum at each of the two session that were scheduled 28 ± 7 days apart.…”

“…Thus, the study by Shaher et al is severely hampered by methodological drawbacks as it makes no mention of concurrent ED treatments, fails to perform any statistical comparisons between the overall IIEF-EF scores in the PRP and placebo groups, and was not pre-registered in any form. In the third randomized controlled trial, Masterson et al allocated a cohort of organic ED patients into PRP (n = 28) and saline solution (n = 33) groups [ 27 ]. The authors employed the same MCID definition used in the two aforementioned studies [ 16 , 26 ].…”

“…The increase in IIEF-EF at 3 months was not statistically significant, and there was no significant difference between the two subsets ( p = 0.662). Despite efforts to reduce methodological drawbacks and bias through a double-blinded design, several limitations were acknowledged, including a small sample size, a high dropout rate, a short follow-up time, and differences in patient populations; furthermore, the authors reported a higher prevalence of patients with prediabetes in the control group [ 27 ].…”

Platelet-rich Plasma for the Treatment of Erectile Dysfunction: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial. Reply.

“…To the Editor: We thank the authors for their commentary and critiques of our recently published clinical trial assessing the safety and efficacy of 2 injections of platelet-rich plasma (PRP) in men with mild to moderate erectile dysfunction (ED). 1 We feel it is paramount to study PRP and other restorative therapies, and create level 1 evidence and counsel patients adequately about their efficacy. 2…”

“…1 We feel it is paramount to study PRP and other restorative therapies, and create level 1 evidence and counsel patients adequately about their efficacy. 2…”