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

Condition(s) studied

Investigational drug(s) / intervention(s)

Injection: patients randomized in intervention group will use also penile extender

Study 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)

Eligibility

Primary outcome measure(s)

• patient satisfaction — From enrollment to the end of follow-up at 6 months
  using PDQ questionnaire

Trial sites (1)

More Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico trials in Italy