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
NCT07010900 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2025-06-08
Summary
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
- Peyronie Disease
- Penile Curvature
- PRP Injection
- Cord Blood
- Randomised Clinical Trial
- Penile Injection Therapy
Interventions
- PROCEDURE
-
Injection
patients randomized in intervention group will use also penile extender
Sponsors & Collaborators
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-28
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Italy
Study Locations
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