Peyronie's disease and mechanotransduction: an in vitro analysis of the cellular changes to Peyronie's disease in a cell-culture strain system.
Eric Chung, Ling De Young, Matthew Solomon...
https://pubmed.ncbi.nlm.nih.gov/23421851Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
MALE
ID07010900
Platelet-Rich Plasma Injections From Cord Blood + Penile Traction vs. Penile Traction Alone in Patients With Peyronie's Disease
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-06-08
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the usefulness of Platelet-Rich Plasma Injections from Cord Blood (CB-PRP) in treating Peyronie's disease, a condition involving penile curvature. This study compares patient satisfaction and other health measures between two groups: those using penile traction alone and those using penile traction combined with CB-PRP injections. The main goal is to assess satisfaction using the Peyronie's Disease Questionnaire (PDQ) at 1 and 3 months after treatment. Participants will be randomly assigned to one of two groups. One group will use a penile extender device alone, while the other will receive three CB-PRP injections every 15 days in addition to using the penile extender. This open-label study takes place at a single center and is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. During the study, researchers will measure penile curvature with a goniometer during spontaneous erection and penile length in a stretched state before and after treatment at 1 and 3 months. Quality of life will also be evaluated using the Short-Form Health Survey 12 (SF-12) and the Hospital Anxiety and Depression Scale (HADS). Patient satisfaction will be followed for up to 6 months after enrollment, with safety and health assessments including blood counts and infection screening.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 18Years - 75Years
MALE
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 to 75 years
- Diagnosed with Peyronie's Disease with penile curvature greater than 30 degrees
- Candidates for penile traction treatment
- Good overall health
- Preserved erectile function with IIEF score greater than 20
- Normal complete blood count with platelets between 150,000 and 450,000 bcL
- Negative for HIV, HCV, and HbsAg
- Fertile partner of experimental group participants must use effective contraception during the study
- Provide informed consent to participate
You will not qualify if you...
- History of blood clotting disorders or platelet abnormalities
- Major active infections
- Previous penile surgery other than circumcision or condyloma removal
- Previous infiltrative therapy or penile traction treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 6 months
Participants receive either platelet-rich plasma injections from cord blood combined with penile traction or penile traction alone as part of the study intervention.
Regular visits during treatment period
Follow-up
Duration - Up to 6 months from enrollment
Participants are monitored for patient satisfaction and treatment outcomes following the active treatment phase.
Visits at scheduled intervals during follow-up
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
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Research Team
F
Franco Gadda, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The effect of penile traction device in men with Peyronie's disease on penile curvature, penile length, and erectile dysfunction: a systematic review and meta-analysis.
Nazal A Almsaoud, Omar Safar, Saad Thamer Alshahrani...
https://pubmed.ncbi.nlm.nih.gov/38106680Platelet-rich plasma and platelet gel: a review.
Peter A M Everts, Johannes T A Knape, Gernot Weibrich...
https://pubmed.ncbi.nlm.nih.gov/16921694Penile traction therapy for Peyronie's disease-what's the evidence?
Mustafa Faruk Usta, Tumay Ipekci
https://pubmed.ncbi.nlm.nih.gov/27298777Risk factors for emotional and relationship problems in Peyronie's disease.
James F Smith, Thomas J Walsh, Simon L Conti...
https://pubmed.ncbi.nlm.nih.gov/18638001The natural history of Peyronie's disease.
M K Gelbard, F Dorey, K James
https://pubmed.ncbi.nlm.nih.gov/2231932Peyronie's Disease.
Frederick L Taylor, Laurence A Levine
https://pubmed.ncbi.nlm.nih.gov/17983892