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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-75
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Injection

    Procedure/Surgery

    patients randomized in intervention group will use also penile extender

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Penile extenderNo intervention 0 interventions
Group B: CB-PRP InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

patient satisfaction

using PDQ questionnaire

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.