Treatment of Peyronie's Disease With Platelet-Rich Plasma

NCT06789510 | Active Not Recruiting DMC

• 1 other identifier: H-24019622-pilot
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peyronies Disease

Keywords

PRP; Platelet-Rich Plasma

Outcome Measures

Primary Outcomes (2)

• Platelet Concentration in the PRP

  In the placebo sessions, the Platelet-Rich Plasma (PRP) sample (prepared using the Magellan Autologous Platelet Separator) will be sent for analysis of platelet concentration levels to ensure the quality of the PRP.

  The 6 week intervention period.

• Evaluation of the Blinding Process

  After each injection, both the administering physician and the participant will be asked to state whether they believe the injection contained PRP or saline. They will also be asked to justify their response, which will allow for adjustments to the practical implementation of the blinding process in the Randomized Controlled Trial (RCT), if necessary.

  The 6 week intervention period.

Secondary Outcomes (9)

• Adverse Events

  From the first injection to the 3 months post intervention follow-up.

• Degree Changes in Penile Curvature.

  From enrollment to 3 months post intervention.

• Changes in Plaque Size

  From enrollment to 3 months post intervention.

• Changes in the Peyronie's Disease Questionnaire (PDQ)

  From enrollment to 3 months post intervention.

• Changes in the Erection Hardness Score (EHS)

  From enrollment to 3 months post intervention.

Study Arms (2)

Platelet Rich Plasma (PRP)

EXPERIMENTAL

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.

Other: Autologous Platelet Rich Plasma

Saline Solution (Placebo)

PLACEBO COMPARATOR

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.

Other: Saline solution

Interventions

Autologous Platelet Rich Plasma OTHER

10 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.

Also known as: PRP

Platelet Rich Plasma (PRP)

Saline solution OTHER

10 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.

Also known as: Placebo

Saline Solution (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev and Gentofte University Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Penile Induration

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant and the investigator/treating doctor will be masked. The syringes will be covered. Only the care provider who prepare the PRP will not be masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Clinical Assistant

Model Details: Each participant will receive six injections (three Platelet-Rich Plasma (PRP) and three saline), administered weekly in a randomized sequence. The RedCap randomization module ("Research Electronic Data Capture", a data management system used for research data) will ensure that each participant receives three injections of each type.

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 23, 2025
• Study Start: March 10, 2025
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)