PRP for Treatment of Peyronie's Disease

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami

Criteria

Inclusion Criteria:

1. Be Male

2. Be 18 to 75 years of age (inclusive).

3. Be able to provide written informed consent

4. Have a diagnosis of PD with evidence of active or stable disease as determined by the investigator

5. Penile curvature deformity of >30° to <120°

6. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.

2. Previous intralesional injection therapy (such as Xiaflex) for PD.

3. Previous history of priapism or penile fracture

4. PD characterized by a ventral plaque

5. Severe erectile dysfunction as characterized with an International Index of Erectile Function (IIEF) score ≤ 16

6. Actively on anticoagulation during time frame of injections (aspirin 81 mg will be eligible for therapy)

7. Hour-glass deformity

8. Unwilling to participate

9. Medically unfit for sexual intercourse as deemed by the principal investigator

10. Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.

11. 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.