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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
MALE
ID07010900

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

On this page

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

Age: 18Years - 75Years
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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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