Recruiting

NCT Number: NCT07010900

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

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)

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Peyronie Disease Central Nervous System Diseases Central Nervous System Infections Connective Tissue Diseases Cord Blood Dyssomnias Genital Diseases Genital Diseases, Male Infections Insomnia, Fatal Familial Male Urogenital Diseases Nervous System Diseases Neurodegenerative Diseases PRP Injection Penile Curvature Penile Diseases Penile Induration Penile Injection Therapy Prion Diseases Randomised Clinical Trial Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection

Procedure

patients randomized in intervention group will use also penile extender

Other names: CB-PRP

Primary outcomes

patient satisfaction

Time frame: From enrollment to the end of follow-up at 6 months

using PDQ questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Franco Gadda, MD

CONTACT

[email protected]

+390255033478

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

Platelet-Rich Plasma Injections From Cord Blood + Penile Traction vs. Penile Traction Alone in Patients With Peyronie's Disease.

Acronym: CB-PRP-TRAC1

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 8, 2025
Registry last updated: Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting