Platelet-Rich Plasma Injections From Cord Blood + Penile Traction vs. Penile Traction Alone in Patients With Peyronie's Disease.
| Registry | NCT07010900, acronym CB-PRP-TRAC1 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 42 (Estimated) |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other) |
| Conditions | Peyronie Disease, Penile Curvature, PRP Injection, Cord Blood, Randomised Clinical Trial, Penile Injection Therapy |
| Interventions | Injection (Procedure) |
| Dates | start 2025-05-28 (estimated), primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2025-06-08, last updated 2025-06-08 |
| Locations | 1 site in Italy |
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All trials for Peyronie Disease All trials for Penile Curvature All trials of Injection
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)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Penile extender | No intervention | routine treatment with medical device | |
| CB-PRP Injection | Experimental | Procedure: Injection | experimental arm |
Sex: Male, ages: 18 Years to 75 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |