Treatment of Peyronie's Disease With Platelet-Rich Plasma

Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peyronies Disease
• Intervention / Treatment: Other: Autologous Platelet Rich Plasma; Other: Saline solution

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev and Gentofte University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet Rich Plasma (PRP); 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; 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.; Other Names: PRP
Placebo Comparator: Saline Solution (Placebo); 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; 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.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Recording of adverse events following injections to ensure safety. In other studies and clinical practice, no serious adverse events have been reported. However, mild adverse events may include slight pain, ecchymosis, and hematoma.	From the first injection to the 3 months post intervention follow-up.
Degree Changes in Penile Curvature.	Dominant curvature angles will be measured using a goniometer based on images of the participants' erect penis (in two planes) at baseline and at follow-up three months after the final injection. The images will be captured in the outpatient clinic following the administration of Alprostadil to ensure high quality and consistency.	From enrollment to 3 months post intervention.
Changes in Plaque Size	Plaque size will be measured at baseline and three months after the final injection using a ruler, calculated as the product of plaque length and width. Participants with more than two plaques or with significant plaque heterogeneity will not have plaque size measured and will be excluded from these analyses but may still participate in the study.	From enrollment to 3 months post intervention.
Changes in the Peyronie's Disease Questionnaire (PDQ)	The Peyronie's Disease Questionnaire (PDQ) is a 15-question self-reported survey that measures the impact and severity of Peyronie's disease (PD) symptoms in 3 domains, including psychological and physical symptoms, penile pain and symptom bother. Higher domain scores indicate a greater negative impact. The range of scores for each domain is 0 to 24 for PD psychological and physical symptoms, 0 to 30 for penile pain and 0 to 16 for PD symptom bother. The participants will complete the survey at baseline and three months after the final injection.	From enrollment to 3 months post intervention.
Changes in the Erection Hardness Score (EHS)	The participants will rate the hardness of their erection via the single-item Likert scale EHS, at baseline and three months after the final injection. The scale is from 0-4. 0 is no erection, the higher the score the better erection.	From enrollment to 3 months post intervention.
Changes in the Major Depression Inventory (MDI)	The Major Depression Inventory (MDI) is a patient-reported outcome measure to assist with diagnosing and evaluation of the severity of a patient's depression. The MDI score ranges from 0 to 50, where 0 represents no depression symptoms and 50 represents the most severe depression symptoms. The participants will complete the MDI questionnaire at baseline and three months after the final injection. The MDI is included due to previously described associations between Peyronie's disease and depression. The data may be used to assess the impact of disease progression on potential depressive symptoms.	From enrollment to 3 months post intervention.
The Ability to Engage in Sexual Intercourse (question)	The participants will be assessed at baseline and three months after the final injection regarding their ability to engage in sexual intercourse. This will be assessed by asking participants a single binary question: whether they are able to engage in sexual intercourse (yes or no).	From enrollment to 3 months post intervention.
Preference for Surgical Intervention (question)	The participants will be inquired about their preference for surgical intervention in relation to the current penile curvature at baseline and 3 months after the final injection. This will be assessed by asking participants a single binary question: whether they wish to undergo surgery given their current curvature (yes or no).	From enrollment to 3 months post intervention.
Satisfaction	The participants will complete a Global Assessment Scale Questionnaire regarding overall treatment satisfaction at the 3-month follow-up after the final injection. The questionnaire consists of a single question regarding the participants' overall satisfaction with the treatment, to be answered on a scale from 1 to 5. A higher value indicates greater satisfaction.	From enrollment to 3 months post intervention.

Collaborators and Investigators

• Sponsor: Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: PRP; Platelet-Rich Plasma
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Connective Tissue Diseases; Penile Diseases; Penile Induration
• Other Study ID Numbers: H-24019622-pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No