Platelet-Rich Plasma for Peyronie's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Platelet Rich Plasma, Saline solution.
- Who it may be relevant to
- Registry conditions: Peyronies Disease. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Randomized, Double-blind, Placebo-controlled Clinical Trial
Overview
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.
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. 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.
Interventions
- Other 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. - Other 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.
Primary outcome measures
- Degree Changes in Penile Curvature. [Time frame: From enrollment to 12 months post intervention.]
Secondary outcome measures (7)
- Changes in Plaque Size [Time frame: From enrollment to 12 months post intervention.]
- Changes in the Peyronie's Disease Questionnaire (PDQ) [Time frame: From enrollment to 3 months post intervention.]
- Changes in the Erection Hardness Score (EHS) [Time frame: From enrollment to 12 months post intervention.]
- Changes in the Major Depression Inventory (MDI) [Time frame: From enrollment to 12 months post intervention.]
- The Ability to Engage in Sexual Intercourse (question) [Time frame: From enrollment to 12 months post intervention.]
- Preference for Surgical Intervention (question) [Time frame: From enrollment to 12 months post intervention.]
- Changes in Global Assessment Scale Questionnaire [Time frame: From 3 to 12 months post intervention.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Herlev and Gentofte University Hospital — Herlev
Identifiers
NCT: NCT07117955 · H-24019622