Platelet-Rich Plasma for Peyronie's Disease

Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Randomized, Double-blind, Placebo-controlled Clinical Trial

The purpose of this clinical trial is to evaluate the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase.

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. A total of 84 patients with Peyronie's disease will be included. Participants will be stratified based on the degree of penile curvature at baseline (30-60 degrees or >60 degrees) and randomized in a 1:1 ratio to receive either active treatment with Platelet-Rich Plasma (PRP) or placebo (saline). Subsequently, participants will attend weekly injection sessions for 3 weeks consisting of either PRP or saline in a randomized, double-blind manner. A follow-up visit will take place three months after the final injection for outcome assessment. Two additional long-term follow-up visits will be conducted at 6 and 12 months post-treatment. Analysis will then be conducted.

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
• Clearly palpable penile plaque

Exclusion Criteria:

• Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors
• Hourglass malformation
• Severely calcified plaques where injection is considered unfeasible
• Intrapenile plaque
• History of priapism.
• History of penile fracture.
• Previous treatment for PD with injections and/or surgery.
• Antithrombotic therapy associated with a high risk of bleeding