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A phase 2 randomized, placebo-controlled crossover trial to evaluate safety and efficacy of platelet-rich plasma injections for Peyronie’s disease: clinical trial update

International Journal of Impotence Research (2024)Cite this article

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Abstract

Peyronie’s Disease (PD) is characterized by fibrotic plaques in the penile tunica albuginea, causing curvature and painful erections. Current treatments have limited established efficacy. Platelet-Rich Plasma (PRP), known for modulating inflammation, offers a potential alternative. This randomized, placebo-controlled, crossover study at the University of Miami assesses PRP’s safety and efficacy for PD. Forty-one PD patients were randomized into PRP-placebo (Group A) and placebo-PRP (Group B) sequences, receiving two injections of each treatment over three months, with a crossover to receive two injections of alternate treatment over the next three months. Assessments include pain scale, goniometry, questionnaires, and curvature evaluations. Preliminary analysis of 28 patients shows that PRP is safe. There were no adverse events, including penile complications, during follow-up. Pain scores during treatments showed no significant difference between PRP and placebo (p = 0.52). Over six months, the PRP-Placebo group’s median PDQ score decreased from 1.9 (IQR: 1.7–2.9) to 1.4 (IQR: 0.7–2.1). This change was not statistically significant (p = 0.098). In contrast, the Placebo-PRP group showed a significant reduction from 1.8 (IQR: 1.4–2.6) to 1.2 (IQR: 1.0–2.0) (p = 0.020). No significant changes in IIEF scores were observed. Both groups initially had a median penile curvature of 40 degrees. At 3 months, the PRP-Placebo group’s curvature decreased to 38 degrees (IQR: 35–47.5), while the Placebo-PRP group decreased to 35 degrees (IQR: 30–60). At 6 months, the PRP-Placebo group showed a significant reduction to 25 degrees (IQR: 20–40, p = 0.047), while the Placebo-PRP group’s reduction to 32.5 degrees (IQR: 20–50) was not significant (p = 0.490). These early results indicate a delayed PRP effect, prompting further investigation into its long-term impacts. Although limited by sample size, this study suggests PRP injections as a safe treatment for PD, with ongoing research aiming to clarify its therapeutic value.

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Fig. 1: Figure 1 illustrates the degree of penile curvature over time in patients receiving PRP-placebo and placebo-PRP treatments.

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References

  1. Brady L, Stender CJ, Wang YN, Schade GR, Maxwell AD, Wessells H, et al. Mechanical characterization of fibrotic and mineralized tissue in Peyronie’s disease. Int J Impot Res. 2022;34:477–86. https://doi.org/10.1038/s41443-021-00439-2.

    Article  PubMed  Google Scholar 

  2. American Urological Association. Peyronie’s Disease Guideline. 2021. Retrieved from https://www.auanet.org/guidelines/peyronies-disease-guideline.

  3. European Association of Urology. Sexual and Reproductive Health - Penile Curvature. 2022. Retrieved from https://uroweb.org/guideline/sexual-and-reproductive-health/#6.

  4. Zugail, AS, Alshuaibi, M, Lombion, S, Beley, S. Safety and feasibility of percutaneous needle tunneling with platelet-rich plasma injections for Peyronie’s disease in the outpatient setting: a pilot study. Int J Impot Res. 2023. https://doi.org/10.1038/s41443-023-00744-y.

  5. Achraf C, Ammani AP, El Anzaoui J. Platelet-rich plasma in patients affected with Peyronie’s disease. Arab J Urol. 2022;21:69–75. https://doi.org/10.1080/2090598X.2022.2135284.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Karakose A, Yitgin Y. A new alternative approach to management of acute phase Peyronie’s disease: low-intensity extracorporeal shockwave therapy and platelet-rich plasma. Minerva Urol Nephrol. 2023. https://doi.org/10.23736/S2724-6051.23.05458-7.

  7. Schirmann A, Boutin E, Faix A, Yiou R. Tolerance and efficacy of platelet-rich plasma injections in Peyronie’s disease: pilot study. Prog Urol. 2022;32:856–61. https://doi.org/10.1016/j.purol.2022.05.004.

    Article  CAS  PubMed  Google Scholar 

  8. Hellstrom WJ, Feldman R, Rosen RC, Smith T, Kaufman G, Tursi J. Bother and distress associated with Peyronie’s disease: validation of the Peyronie’s disease questionnaire. J Urol. 2013;190:627–34. https://doi.org/10.1016/j.juro.2013.01.090.

  9. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49:822–30. https://doi.org/10.1016/s0090-4295(97)00238-0.

    Article  CAS  PubMed  Google Scholar 

  10. Virag R, Sussman H, Lambion S, de Fourmestraux V. Evaluation of the benefit of using a combination of autologous platelet rich-plasma and hyaluronic acid for the treatment of Peyronie’s disease. Sex Health Issues. 2017;1:1–8. https://doi.org/10.15761/SHI.1000102.

    Article  Google Scholar 

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Funding

This work was supported by NIH Grant R01 DK130991, UE5DK137308, and Clinician Scientist Development Grant from the ACS to RR.

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Author notes

  1. These authors contributed equally: Braian R. Ledesma, David A. Velasquez.

Authors and Affiliations

  1. Desai Sethi Urology Institute, University of Miami, Miller School of Medicine, Miami, FL, USA

    Braian R. Ledesma, David A. Velasquez, Christabel Egemba, Manuel Molina, Emad Ibrahim, Francesco Costantini-Mesquita, Russell Saltzman & Ranjith Ramasamy

  2. Department of Urology, Wake Forest University School of Medicine, Winston-Salem, NC, USA

    Nicholas A. Deebel

  3. Biostatistics and Bioinformatics Shared Resource, Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Miami, FL, USA

    Sunwoo Han & Isildinha M. Reis

  4. Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA

    Isildinha M. Reis

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  1. Braian R. Ledesma
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Contributions

BRL, DAV, CE, MM, EI, FC, NAD, SH, IMR, RS, and RR prepared the manuscript and figures. All authors approved the submitted manuscript.

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Correspondence to Ranjith Ramasamy.

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Ledesma, B.R., Velasquez, D.A., Egemba, C. et al. A phase 2 randomized, placebo-controlled crossover trial to evaluate safety and efficacy of platelet-rich plasma injections for Peyronie’s disease: clinical trial update. Int J Impot Res (2024). https://doi.org/10.1038/s41443-024-00844-3

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