Cord Blood, Penile Curvature, Penile Injection Therapy, Peyronie Disease, PRP Injection, Randomised Clinical Trial
Conditions
Keywords
penile exteder, peyronie disease, prp, cord blood prp
Brief 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)
Interventions
PROCEDUREInjection
patients randomized in intervention group will use also penile extender
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | From enrollment to the end of follow-up at 6 months | using PDQ questionnaire |
Countries
Italy
Contacts
Primary ContactFranco Gadda, MD
Outcome results
None listed