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Cited by 105Sexual function and dysfunction studiesPeriodontal Regeneration and TreatmentsUrological Disorders and Treatments

Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Poulios, Evangelos, Mykoniatis, Ioannis, Pyrgidis, Nikolaos, Zilotis, Filimon, Kapoteli, Paraskevi, Kotsiris, Dimitrios, Kalyvianakis, Dimitrios, Hatzichristou, Dimitrios·2021·The Journal of Sexual Medicine
DOI 10.1016/j.jsxm.2021.03.008
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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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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
ORCID
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)
DOI
10.1016/j.jsxm.2021.03.008
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
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • The Journal of Sexual Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
  • Health Sciences › Medicine › Urology › 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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