PRP for Treatment of Peyronie's Disease

Phase 2

Active, not recruiting

• Conditions: Sexual Dysfunction, Physiological; Genital Diseases, Male; Sexual Dysfunction Male; Peyronie Disease
• Interventions: Drug: Autologous Platelet Rich Plasma; Other: Saline Solution

• Registration Number: NCT04512287
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-13
• Study Start: 2021-03-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: Placebo followed by Autologous PRP Group	Autologous Platelet Rich Plasma	Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later.
Experimental: Autologous PRP followed by Placebo Group	Saline Solution	Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later.
Experimental: Placebo followed by Autologous PRP Group	Saline Solution	Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later.
Experimental: Autologous PRP followed by Placebo Group	Autologous Platelet Rich Plasma	Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later.

Primary Outcome Measures

Name	Time	Method
Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).	7 months	Treatment efficacy will be assessed via the percentage of participants achieving any decrease in Peyronie's disease Questionnaire (PDQ) sub-domain scoring from baseline. The sub-domains that will be assessed in primary outcome is Psychological and Physical Symptoms and Symptom Bother. PDQ is a validated 15-item questionnaire that assess Psychological and Physical Symptoms, Symptom Bother, and Penile Pain subdomains. The Psychological and Physical Symptoms subdomain is measured from 0 to 24 (most severe symptoms). Symptom Bother subdomain is measured from 0 to 30 (most severe pain).
Percentage of subjects in each group who attain degree change in penile curvature.	7 months	Treatment efficacy of PRP will be assessed via the percentage of participants achieving degree change in penile curvature from baseline. Degree of curvature will be measured using a goniometer with the aid of injection of vasoactive substance into the penis.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events in all patients	Baseline, 6 months (post-intervention)	Safety will be evaluated via the incidence of adverse events as assessed by treating physician

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States