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Platelet-Rich Plasma Injections From Cord Blood Penile Traction vs. Penile Traction Alone in Patients With Peyronies Disease
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-06-08
42
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the usefulness of Platelet-Rich Plasma Injections from Cord Blood CB-PRP in treating Peyronies disease, a condition involving penile curvature. This study compares patient satisfaction and other health measures between two groups those using penile traction alone and those using penile traction combined with CB-PRP injections. The main goal is to assess satisfaction using the Peyronies Disease Questionnaire PDQ at 1 and 3 months after treatment. Participants will be randomly assigned to one of two groups. One group will use a penile extender device alone, while the other will receive three CB-PRP injections every 15 days in addition to using the penile extender. This open-label study takes place at a single center and is sponsored by Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico. During the study, researchers will measure penile curvature with a goniometer during spontaneous erection and penile length in a stretched state before and after treatment at 1 and 3 months. Quality of life will also be evaluated using the Short-Form Health Survey 12 SF-12 and the Hospital Anxiety and Depression Scale HADS. Patient satisfaction will be followed for up to 6 months after enrollment, with safety and health assessments including blood counts and infection screening.
CONDITIONS
Brief 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...
- Male patients aged 18 to 75 years
- Diagnosed with Peyronie's Disease with penile curvature greater than 30 degrees
- Candidates for penile traction treatment
- Good overall health
- Preserved erectile function with IIEF score greater than 20
- Normal complete blood count with platelets between 150,000 and 450,000 bcL
- Negative for HIV, HCV, and HbsAg
- Fertile partner of experimental group participants must use effective contraception during the study
- Provide informed consent to participate
You will not qualify if you...
- History of blood clotting disorders or platelet abnormalities
- Major active infections
- Previous penile surgery other than circumcision or condyloma removal
- Previous infiltrative therapy or penile traction treatment
Research Team
F
Franco Gadda, MD
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