PRP for Treatment of Peyronie's Disease

University of Miami

Status and phase: Active, not recruiting; Phase 2

Conditions: Sexual Dysfunction Male; Sexual Dysfunction, Physiological; Peyronie Disease; Genital Diseases, Male

Treatments: Other: Saline Solution; Drug: Autologous Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04512287

20200779

Details and patient eligibility

About

The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).

Enrollment: 65 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups

Experimental: Autologous PRP followed by Placebo Group

Experimental group

Description:

Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later.

Treatment:

Drug: Autologous Platelet Rich Plasma

Other: Saline Solution

Experimental: Placebo followed by Autologous PRP Group

Experimental group

Description:

Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later.

Treatment:

Drug: Autologous Platelet Rich Plasma

Other: Saline Solution