Status:
COMPLETED
PRP for Treatment of Peyronie's Disease
Lead Sponsor:
University of Miami
Conditions:
Peyronie Disease
Sexual Dysfunction, Physiological
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).
Eligibility Criteria
Inclusion
- Be Male
- Be 18 to 75 years of age (inclusive).
- Be able to provide written informed consent
- Have a diagnosis of PD with evidence of active or stable disease as determined by the investigator
- Penile curvature deformity of \>30° to \<120°
- Agree to comply with all study related tests/procedures.
Exclusion
- Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
- Previous intralesional injection therapy (such as Xiaflex) for PD.
- Previous history of priapism or penile fracture
- PD characterized by a ventral plaque
- Severe erectile dysfunction as characterized with an International Index of Erectile Function (IIEF) score ≤ 16
- Actively on anticoagulation during time frame of injections (aspirin 81 mg will be eligible for therapy)
- Hour-glass deformity
- Unwilling to participate
- Medically unfit for sexual intercourse as deemed by the principal investigator
- Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
- Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04512287
Start Date
March 29 2021
End Date
August 11 2025
Last Update
August 14 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136