Cord blood platelet-rich plasma plus penile traction versus traction alone for Peyronie's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-center randomized study in Milan compares penile traction alone to traction combined with three cord blood–derived platelet-rich plasma (CB-PRP) injections given every 15 days. Men with Peyronie's disease, curvature greater than 30 degrees, and preserved erectile function will be randomized to one of the two arms. The primary outcome is patient satisfaction measured with the PDQ at 1 and 3 months after treatment, and secondary outcomes include goniometer-measured curvature, stretched penile length, SF-12 quality of life, and HADS anxiety/depression scores. Safety screening requires normal blood counts, negative HIV/HCV/HBsAg, and exclusion of prior penile surgery or previous injectable or traction therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with Peyronie's Disease (IPP) Penile curvature greater than 30 degrees (autophotography in erection with goniometer measurement) Patients candidates for penile traction Age: 18-75 years Good health conditions Preserved erection (IIEF \>20) Complete blood count with differential and coagulation within the normal range (platelets between 150,000 and 450,000 μL) HIV, HCV, and HbsAg negative The fertile partner of the patient randomized to the experimental group must use an acceptable highly effective contraceptive method (oral contraceptives, intrauterine device, abstinence, vasectomized partner) for the entire duration of the study Informed consent to the study

Exclusion Criteria:

Coagulopathies, platelet disorders Major active infections Previous penile surgery (excluding circumcision and condyloma removal) Previous infiltrative therapy or penile traction treatment

Where it's running

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Franco Gadda, MD
• Email: franco.gadda@policlinico.mi.it
• Phone: +390255033478

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.