Treatment of Peyronie's Disease With Platelet-Rich Plasma

Herlev Hospital

Status: Active, not recruiting

Conditions: Peyronies Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06789510

H-24019622-pilot

Details and patient eligibility

About

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.

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. 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.

Enrollment: 10 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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Platelet Rich Plasma (PRP)

Experimental group

Description:

Each participant will receive 3 PRP injections over the 6-week period, with weekly injections in a randomized sequence. The RedCap randomization module will ensure that each participant receives 3 injections of each type.

Treatment:

Other: Autologous Platelet Rich Plasma

Saline Solution (Placebo)

Placebo Comparator group

Description:

Each participant will receive 3 saline injections over the 6-week period, with weekly injections in a randomized sequence. The RedCap randomization module will ensure that each participant receives 3 injections of each type. In addition, Platelet-Rich Plasma (PRP) will be prepared but, instead of being injected, it will be analyzed for platelet count.

Treatment:

Other: Saline solution