Platelet-Rich Plasma for Peyronie's Disease

Herlev Hospital

Status: Enrolling

Conditions: Peyronies Disease

Treatments: Other: Saline solution; Other: Autologous Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT07117955

H-24019622

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 84 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

Platelet Rich Plasma (PRP)

Experimental group

Treatment:

Other: Autologous Platelet Rich Plasma

Saline Solution (Placebo)

Placebo Comparator group

Treatment:

Other: Saline solution