Platelet-Rich Plasma Injections From Cord Blood + Penile Traction vs. Penile Traction Alone in Pa… (NCT07010900) | Clinical Trial Compass
RecruitingNot Applicable
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
Italy42 participantsStarted 2025-05-28
Plain-language 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)
Who can participate
Age range
18 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares cord blood platelet-rich plasma injections combined with penile traction against penile traction alone — is my current stage and type of Peyronie's disease a good match for either of those treatment approaches?
2Since this study is listed as Phase NA and uses cord blood as the source of PRP rather than the patient's own blood, what do we know so far about the safety profile of cord blood-derived PRP injections specifically for Peyronie's disease?
3The trial's main outcome is patient satisfaction rather than objective measures like degree of curvature correction — does that mean there may be less data on physical improvement, and how should I weigh that when considering whether to participate?
4This is an open-label study, so I'd know which treatment group I'm in — but since assignment is randomized, what are the chances I'd receive traction alone without the PRP injections, and would I still have access to PRP if the combination proves more effective?
5Before considering this trial, are there established standard-of-care treatments for my Peyronie's disease — such as collagenase injections or surgery — that I should try first, or does my situation make this trial a reasonable option to discuss now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
patient satisfaction
Timeframe: From enrollment to the end of follow-up at 6 months
Trial details
NCT IDNCT07010900
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico