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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

RecruitingNAAges 18 Years - 75 YearsMaleFondazione IRCCS Ca' Granda, Ospedale Maggiore Poโ€ฆ
NCT07010900 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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)

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๐Ÿ“‹ Eligibility rules (as published)
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 ฮผL) 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
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What it tests

  • Injection
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Where

1 site
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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