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 (CB-PRP-TRAC1)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Randomised Clinical Trial; Cord Blood; Penile Curvature; Penile Injection Therapy; Peyronie Disease; PRP Injection

Treatments: Procedure: Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07010900

CB-PRP-TRAC1

Details and patient eligibility

About

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)

Enrollment: 42 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Penile extender

No Intervention group

Description:

routine treatment with medical device

CB-PRP Injection

Experimental group

Description:

experimental arm

Treatment:

Procedure: Injection