Actively Recruiting
Platelet-Rich Plasma Injections From Cord Blood + Penile Traction vs. Penile Traction Alone in Patients With Peyronie's Disease. Open-label, Single-center Randomized Study
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-06-08
42
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if Platelet-Rich Plasma Injections from Cord Blood (CB-PRP) is useful in Peyronie disease. The primary goal is evaluation of patient satisfaction at 1 and 3 months after treatment completion using the PDQ Questionnaire Secondary Objectives are: * Measurement of penile curvature measured with a goniometer with spontaneous erection before and after treatment (1 and 3 months) * Measurement of penile length in stretching before and after treatment (1 and 3 months) * Evaluation of the improvement in quality of life, through the Short-Form Health Survey 12 (SF-12) health status questionnaire and through the Hospital Anxiety and Depression Scale (HADS) Participants will be randomized in two groups: * penile extender alone * penile extender + CB PRP injection (1 injection every 15 days - 3 in totalinjections)
CONDITIONS
Official Title
Platelet-Rich Plasma Injections From Cord Blood + Penile Traction vs. Penile Traction Alone in Patients With Peyronie's Disease. Open-label, Single-center Randomized Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Peyronie's Disease (IPP) with penile curvature greater than 30 degrees measured by goniometer during erection
- Candidates for penile traction treatment
- Age between 18 and 75 years
- Good overall health
- Preserved erections with International Index of Erectile Function (IIEF) score greater than 20
- Normal complete blood count with differential and coagulation (platelets between 150,000 and 450,000 per microliter)
- Negative for HIV, HCV, and hepatitis B surface antigen (HbsAg)
- Fertile partners of patients in the experimental group must use an effective contraceptive method throughout the study
- Provided informed consent to participate in the study
You will not qualify if you...
- Presence of coagulopathies or platelet disorders
- Major active infections
- Previous penile surgery other than circumcision or condyloma removal
- Previous infiltrative therapy for Peyronie's Disease
- Previous treatment with penile traction devices
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
Research Team
F
Franco Gadda, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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