Autologous Platelet Rich Plasma: 6 mL PRP intralesional injections will be administered. After the injections, participants will be instructed to perform penile stretching exercises daily until the next injection and to continue these exercises after the final injection until the 3-month follow-up.
Saline solution: 6 mL saline solution intralesional injections will be administered. After the injections, participants will be instructed to perform penile stretching exercises daily until the next injection and to continue these exercises after the final injection until the 3-month follow-up.
Study summary
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Degree Changes in Penile Curvature. — From enrollment to 12 months post intervention. Dominant curvature angles will be measured bedside in the outpatient clinic using a goniometer following intracavernosal administration of Alprostadil to ensure high quality and consistency. At the same visit, standardized photographs of the erect penis will be captured (in two plans) to support objective assessment. These procedures will be performed at baseline and at follow-up three months after the final injection.
At the 6- and 12-months long-term follow-up visits, no pharmacological erection induction will be performed. Instead, penile curvature will be assessed based on standardized photographs of the participant's erection taken at home following detailed instructions, allowing evaluation of the durability of any treatment effect.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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