Table 1.
Summary of key details of clinical studies evaluating PRP in ED as a monotherapy.
| References |
Type of study (n = number included) |
PRP preparation method |
Intra-cavernosal injection method |
Primary results | Adverse events | Limitations |
|---|---|---|---|---|---|---|
| Poulios et al. (34) | Double-blind, placebo controlled, RCT (n = 60) | Autologous platelet separator (Magellan Autologous platelet separator) | - Penile tourniquet for 20 min - 5 mL infused into each corpus cavernosum - Compression bandages after injection |
MCID achieved 69% in PRP group vs. 27% in placebo group, p < 0.001 | None observed | - Small cohort of men - Highly selected, single center study population that may lack external validity |
| Alkhayal and Lourdes (Conference abstract) (35) | Prospective cohort study (n = 61) | Automatic dual spin Magellan Arteriocyte machine. | According to American Cellular Medicine Association protocol (unclear from abstract the exact method used, not clear how many injections each patient received) | Mean IIEF5 score before treatment 12.5 (range 5–20) vs. post treatment mean IIEF5 17 (range 5–24), p < 0.001 | None reported | - No placebo or control arm - Large number of losses to follow-up introducing risk of bias - Methods not clearly explained, number of injections not disclosed - Variable follow-up - Mean follow-up only 11 weeks |
| Banno et al. (Conference abstract) (36) | Prospective Cohort study (n = 9) | Not disclosed | One injection only, method of injection not disclosed | Average IIEF5 score prior to injection was 15.6 (range 12–20) vs. 19.9 (range 11–27) (P = 0.157) | None reported | - Moderate ED patients only - Only nine patients included in study - PRP injection used in combination with standard treatments - Variable follow-up period - Likely follow-up period very short |
| Matz et al. (37) | Retrospective cohort analysis (n = 5 men with ED) | - Centrifuged at 6,000 RPMS for 6 min - Supernatant separated using a proprietary system. - 10% CaCl solution added in a 1:10 ratio (“activated”) |
- Intracavernosal injection method not described in detail - Average 2.1 injections |
IIEF-5 scores improved by an average of 4.14 points after PRP therapy (baseline IIEF not reported, result included one patient with Peyronie's disease) | - Mild pain (24%) | - Very small number of men with ED - Heterogenous group of men - severity of ED not evaluated - No baseline IIEF scores were reported - No statistical analysis of results |
| Taş et al. (38) | Prospective cohort analysis (n = 31) | - Centrifuged at 2,800 rpm for 8 min. - The plasma layer centrifuged again at 3,500 rpm for 10 min. - Solution containing 1,000e2,000 103/μL PRP was prepared. |
- Three intracavernosal injections with 15-day intervals between each injection - Topical anesthetic cream (25 mg lidocaine and 25 mg prilocaine) LA was applied - Clamping (20 min) was performed with Stockmann penis clamp - 3 ml PRP was injected into each corpora cavernosa - The injection sites vary by 1 cm in the mid-penile region |
- IIEF5 score improved from 18 to 20 (P < 0.001) - 61.29% of men improved |
- Bruising in 8.6% of injections - One patient developed 4 mm fibrotic plaque (ventral penis), this was not bothersome |
- Evaluated men with metabolic syndrome (thus results may not be generalizable to other causes of ED) - Modest improvement in IIEF |
| Zaghlou et al. (39) | Prospective cohort study (n = 34) | - Centrifuged for 5 min at 1,000 rpm, room temperature. - Manual counting of the platelets on a sample of 10, the platelet count was found to increase by about 8-fold - Plasma layer was again centrifuged for 5 min at 3,000 rpm, room temperature. - The pellet was kept with 1 ml plasma |
- Injections once per week for 2 months - 0.5 ml of PRP concentrate in each corpus cavernosum - After PRP injection, direct pressure was applied to the base of the penis for 1–2 min - Massage of the penis was also done for 1–2 min following the injection |
- Mean increase of IIEF5 score by 5.5 points (P < 0.001) - On multivariable analyses that smoking and baseline IIEF scores independently predicted response to PRP injections (p = 0.040 and p = 0.023, respectively |
- None reported | - Very short term, evaluated men 3 months after starting injections - Small cohort, no control/placebo group - All patients were prescribed PDE5i medications for month after the PRP injections were completed |
| Geyik (40) | Retrospective cohort (n = 184) | - Centrifuged at 3,700 Å~g for 10 min - Supernatant was separated from the remaining blood sample. - Two kits yielded ~12–16 ml of injectable PRP |
- LA cream was applied at least 20 min before injection. - Three injections given, 10–14 days apart - ~3–4 ml of PRP was injected in each one of the four regions: one intracavernosal and three subcutaneous areas (both right and left lateral neural lines and dorsal balanic submucosal region |
- Increase in mean IIEF score of about nine in both groups - Li-SWT and PRP combination treatment did not show an improvement in IIEF scores compared to Li-SWT alone |
- Temporary pain at the site of injections - Mild penile bruising (26%) |
- Study assessing combination therapy—men either underwent Li-SWT or Li-SWT and PRP injection - Men were still using PDE5i medication throughout the study - No randomization (patients chose their treatment) - Differences in age and mean hypertension rations between the two groups - No placebo injection |
| Ruffo et al. (Conference abstract) (41) | Prospective RCT comparing Li-SWT alone (Group 1) vs. LI-SWT plus PRP IC injection (Group 2) (n = 100) | Blood samples were centrifuged at varying speeds until separated into three layers—PRP layer used | - PRP injected directly into corpora as a single shot - One injection per week for 6 weeks |
- Group 1-mean score increased from 14.6 to 17.3 (P < 0.03) - Group 2—mean score increased from 13.7 to 20.2 (P < 0.001) - Intergroup analysis of IIEF p < 0.001—Combination therapy significantly increased scores compared to monotherapy |
- None reported | - Follow-up after 12 and 24 weeks - Total 100 patients allocated 1:1 - Not blinded - No placebo injection given - Abstract only, so information and details on injections etc. limited |
| Chalyj et al. (42) and Epifanova et al. (43) (abstract/review) | - Cohort study - Study to optimize PRP production (n = 75) |
- PRP activated with 10% calcium chloride solution - PRP activated with 10% calcium chloride combined with PDE5i medication - Inactivated PRP |
No data on how injections given or how many given | - Follow-up from day 28 - Statistically significant results seen in all groups |
None reported | - Article in Russian - Results reported in review article by Epifanova et al. (44), report not complete - No baseline data given about the group with regards to severity of ED, and baseline IIEF scores, and characteristics or causes of ED - No placebo group - Variable follow-up period - Follow-up up to max of 6 months |
| Shin-Mei et al. (45) | Prospective single-arm cohort study (n = 30) | - 30 ml blood drawn from each patient - Double spin technique at 500 and 1,500 G for 15 min. - 1–2 ml PRP then obtained |
- Three sessions of PRP IC injections 3 weeks apart - One injection of PRP given into each CC (bilateral) |
- Assessment were done at baseline and 2 weeks after each injection - Significant improvement of 4.556 IEEF5 score (P < 0.001), and 0.72 points in EHS (P < 0.001) - Overall, 82.8% participants found overall improved erectile function. |
- No significant adverse events reported - Small induration at injection site |
- No placebo or control groups for comparison - Single institution - Short follow-up—assessment was done 2 weeks after each injection session and longer-term outcomes not assessed - PDE5i medication and testosterone replacement therapy was allowed |