Table 4 Previous similar studies investigating PRP in ED patients compared to the current research
Study | Design | Number of patients | PRP preparation | Number of injections | Safety | Efficacy |
|---|---|---|---|---|---|---|
Chalyj et al. (2015) [25] | prospective cohort study | 75 patients, 30 patients a PRP,30 a PRP with PDE5 I, 15 PRP | (1) PRP activated with 10% calcium chloride solution (30 patients received this ICI); (2) PRP activated with 10% calcium chloride combined with PDE5i medication (30 in this group); (3) Inactivated PRP (15 patients received this IC injection) | 2 injections 4 weeks apart | No adverse events | A statistically significant rise in IIEF5 score (P > 0.046), PSV (P = 0.005), and RI (P = 0.001) was noted in group 1. PSV (P = 0.028), RI (P = 0.129), and the IIEF5 score (P = 0.046) all showed improvements in group 2. A statistically significant difference was observed in the IIEF5 score (P < 0.05), PSV, and RI (P > 0.05) values in group 3 |
Banno et al. (2017) [21] | prospective cohort study | 9 patients | Could not be found | 1 injection in combination with PDE5 I or vacuum | No adverse events | Average IIEF5 score prior to injection was 15.6 (range 12–20) and at least 4 weeks post injection the score was 19.9 (range 11–27). The difference in scores did not achieve statistical significance |
Matz et al. (2018) [26] | Retrospective | 5 patients | Venipuncture was performed in the clinic. Two separate collection tubes were filled with 9 mL of whole blood. The samples were centrifuged at 6,000 RPMs for six minutes, and the supernatant was separated from the remaining blood sample using a proprietary system. Ten percent calcium chloride solution was then added to the PRP in a 1:10 ratio, converting fibrinogen to fibrin | 1 injection | Mild pain | Potential efficacy is suggested, but larger sample and control are required |
Alkhayal et al. (2019) [27] | Prospective study | 61 patients in PRP group | Automatic dual spin Magellan Arteriocyte machine | 1 injection of prp | No adverse events | Mean follow-up was for 11 weeks only. Mean IIEF5 score before treatment was 12.5 (range 5–20) (considered mild-to-moderate ED) and post treatment mean IIEF5 score was 17 (range 5–24) (mild ED), P < 0.001. Although this study does show a positive result with the use of PRP, there is no placebo-controlled group in the study |
Taş et al. (2021) [22] | Prospective study | 35 patients | Whole blood: 8-min centrifuge at 2800 rpm, followed by plasma: 10-min centrifuge at 3500 rpm (1000–2000 × 103/μL); 3 m | 3 injections with 2 weeks apart | No adverse events | IIEF5 score improved from 18 to 20 (P < 0.001), however despite this improvement the score remained within the mild IIEF5 ED |
Poulios et al. (2021) [23] | Randomized, double blind, placebo-controlled study | 60 patients, 30 in PRP and 30 in placebo group | Magellan Autologous Platelet Separator (NR); 5 mL/corpora | 2 injections 4 weeks apart | No adverse events | 20/29 (69%) of men in the PRP group vs. 7/26 (27%) of the men in the placebo group achieved MCID, p < 0.001 |
Shaher et al. (2023) [24] | Prospective randomized placebo controlled | 109 patients (9 excluded) to PRP or saline placebo | Whole blood: 5-min centrifuge at 2500 rpm, followed by plasma: 10-min centrifuge at 3500 rpm (NR); 3 mL/corpora via 1 mL at 3 sites | 3 injections with 2 weeks apart | No adverse events | Significant improvement at 1,3 months follows up that slightly dropped at 6- month .76% patient 0f PRP group had an improved IIEF with MCID compared to only 18% in the saline group |
Masterson et al. (2023) [20] | Prospective, randomized, double-blind, placebo controlled, clinical study | 61 patients | Arthrex Angel PRP system (NR); 2.5 mL/corpora | 2 injections 4 weeks apart | 1 minor adverse event in each group | 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) |
Current study | Prospective randomized placebo controlled | 52patients, 26 in PRP & 26 in saline group | Magellan Autologous Platelet Separator; 5 ml/corpora | 3 injections with 15 ± 3 days treatment interval | No adverse events | Prior to injection, the average IIEF5 score for the PRP group was 15.9, whereas the saline group's score was 15.7. At 1, 3 and 6 months, the PRP group outperformed the saline group, although the difference in scores did not reach statistical significance |