Treatment of Peyronie's Disease with Platelet-Rich Plasma

Last updated: March 10, 2025
Sponsor: Herlev Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peyronie's Disease

Treatment

Saline solution

Autologous Platelet Rich Plasma

Clinical Study ID

NCT06789510
H-24019622-pilot
  • Ages > 18
  • Male

Study Summary

The purpose of this pilot study is to optimize a planned randomized, double-blind, placebo-controlled clinical trial evaluating the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase. The pilot study aims to identify potential challenges in the practical execution of the clinical trial, particularly regarding PRP preparation and the blinding process. Furthermore, it seeks to evaluate the effects of PRP injections.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older

  • Be able to provide written informed consent

  • Diagnosis of PD without active pain and without progressive curvature over the past 3 months (fibrotic phase).

  • Penile curvature of 30-95 degrees

Exclusion

Exclusion Criteria:

  • Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors

  • Hourglass malformation

  • Severely calcified plaques where injection is considered unfeasible

  • History of priapism.

  • History of penile fracture.

  • Previous treatment for PD with injections and/or surgery.

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Saline solution
Phase:
Study Start date:
March 10, 2025
Estimated Completion Date:
January 01, 2026

Study Description

The study protocol is structured such that participants, after being informed about the project and providing consent, will attend a baseline visit where relevant data will be collected from the participant, questionnaires, the patient's medical record, and through an objective examination. Subsequently, participants will attend weekly injection sessions for 6 weeks, during which they will receive 3 PRP injections and 3 saline injections (placebo) in a randomized order. Three months after the final injection, participants will attend a follow-up visit, where the final data will be collected. Analysis will then be conducted.

Connect with a study center

  • Herlev and Gentofte University Hospital

    Herlev, 2730
    Denmark

    Active - Recruiting

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