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Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
Abstract
BACKGROUND: Animal studies postulate that platelet-rich plasma (PRP) injections improve key elements of the pathophysiologic mechanisms leading to erectile dysfunction (ED). AIM: To conduct the first double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of PRP injections in patients with mild and moderate ED. METHODS: Sixty sexually active patients with mild and moderate ED were randomly assigned to two sessions, with a one-month difference, of 10 mL PRP (n = 30) or placebo (n = 30) intracavernosal injections. An FDA-approved separation system was used. Patients were evaluated at 1, 3 and 6 months after completion of the treatment protocol. A per-protocol analysis was applied. All participants withheld any ED treatment during the trial. OUTCOMES: The achievement of minimal clinically important difference (MCID) in the International Index of Erectile Function - Erectile Domain (IIEF-EF) from baseline to 6 months after final treatment. Erectile function at all time points, as well as safety of PRP injections, were also evaluated. RESULTS: At 6 months, a MCID was achieved by 20/29 (69%) patients in the PRP group compared to 7/26 (27%) in the placebo group. The risk difference between the two groups was 42% (95%CI: 18-66), P < 0.001 and the baseline-adjusted mean between-group-difference in the IIEF-EF score was 3.9 points (95%CI: 1.8-5.9). Similarly, a statistically significant difference of both the number of participants attaining a MCID and the IIEF-EF score was also observed at the 1- and 3-month evaluation between the two groups. Accordingly, patients receiving PRP were more satisfied with the treatment. No adverse events were observed during the study period. CLINICAL IMPLICATIONS: Intracavernosal PRP injection therapy used as outlined in this trial appears to be a safe and effective short-term treatment for the management of mild to moderate ED. STRENGTHS & LIMITATIONS: We conducted the first clinical trial exploring the role of PRP in the management of ED. Conversely, our findings lack external validity due to single-center design. Furthermore, our results cannot be extrapolated to other PRP separation systems. CONCLUSIONS: PRP intracavernosal injections may be a promising addition to the urologist's armamentarium for the management of ED. Still, further high-quality studies are warranted to corroborate our findings. Evangelos P, Mykoniatis I, Pyrgidis N, et al. Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. J Sex Med 2021;18:926-935.
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“Platelet-rich plasma intracavernosal injections have potential as a promising treatment option for ED and PD in urology.135,136,137”
From Research advances in Peyronie's disease: a comprehensive review on genomics, pathways, phenotypic manifestation, and therapeutic targets. (2024) · cites this paper as [136]
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Gurzhenko, Y. (2025) · Ukrainian Journal of Urology · doi:10.71217/uju.2(6).2025.14-44
Utilisation du PRP en andrologie : focus sur dysfonction érectile et Lapeyronie
Baudry, A., & Schirmann, A. (2025) · Progrès en Urologie - FMC · doi:10.1016/j.fpurol.2025.08.009
Kamci, T. O., Azizoğlu, M., Klyuev, S., Okur, M. H., Aydoğdu, H., Escolino, M., Yildiz, A. P. Z., Esposito, C., & Shehata, S. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14217620
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Regenerative Therapies for Erectile Dysfunction: How Far Are We with the Evidence?
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Advances in the Treatment of Erectile Dysfunction
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Adipose Tissue-Derived Stem Cells in Treatment of Erectile Dysfunction
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Knigavko, O. V., & Hervig, R. (2026) · Research Square · doi:10.21203/rs.3.rs-9247875/v1
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Systematic review on the safety and effectiveness of restorative therapies for erectile dysfunction
Kohn, T. P., El‐Sakka, A. I., Fácio, F. N., Martínez‐Salamanca, J. I., Raheem, O., Park, K., Lin, G., Goldstein, I., Cocci, A., Hamel, C., et al. (2026) · The Journal of Sexual Medicine · doi:10.1093/jsxmed/qdag145
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Metadata
- Authors
- Poulios, E., Mykoniatis, I., Pyrgidis, N., Zilotis, F., Kapoteli, P., Kotsiris, D., Kalyvianakis, D., & Hatzichristou, D.
- Affiliations
- Aristotle University of Thessaloniki (GR)
- Corresponding author
- Mykoniatis, Ioannis
- Venue
- The Journal of Sexual Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2021-05
- Volume
- 18
- Issue
- 5
- Pages
- 926-935
- ISSN
- 1743-6095 (ISSN-L)
- OpenAlex
- W3158399656
- Cited by
- 105
- References
- 43
- Citations by year
- 2026: 26 · 2025: 16 · 2024: 29 · 2023: 20 · 2022: 10 · 2021: 4
- FWCI
- 11.29
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Sexual Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Health Sciences › Dentistry › Periodontics › Periodontal Regeneration and Treatments
- Health Sciences › Medicine › Urology › Urological Disorders and Treatments
- Keywords
- platelet-rich plasma, erectile dysfunction, intracavernous injection, IIEF-EF, treatment efficacy, treatment safety, patient satisfaction, minimal clinically important difference, adverse events
- MeSH terms
- Double-Blind Method, Humans, Erectile Dysfunction, Male, Penile Erection, Treatment Outcome, Platelet-Rich Plasma
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