PRP for Treatment of Peyronie's Disease

A Randomized, Double-Blind, Placebo Controlled, Crossover Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma for Treatment of Peyronie's Disease

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

Study Overview

• Status: Recruiting
• Conditions: Sexual Dysfunction, Physiological; Genital Diseases, Male; Peyronie Disease; Sexual Dysfunction Male
• Intervention / Treatment: Drug: Autologous Platelet Rich Plasma; Other: Saline Solution

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kevin Chu, MD; Phone Number: 305-243-4562; Email: kevin.chu@jhsmiami.org
• Study Contact Backup: Name: Ranjith Ramasamy, MD; Phone Number: 305-243-4562; Email: ramasamy@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Kevin Chu, MD; Phone Number: 305-243-4562; Email: kevin.chu@jhsmiami.org
      • Principal Investigator: Ranjith Ramasamy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Autologous PRP followed by Placebo Group; Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later.	Drug: Autologous Platelet Rich Plasma; 2 sessions of Autologous PRP will be administered 15 days apart. Each injection will be 0.5 mL of PRP injected into the Peyronie's disease penile plaque.; Other Names: PRP; Other: Saline Solution; 2 sessions of saline injection will be administered 15 days apart. Each injection will be 0.5 mL of normal saline injected into the Peyronie's disease penile plaque.
Experimental: Experimental: Placebo followed by Autologous PRP Group; Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later.	Drug: Autologous Platelet Rich Plasma; 2 sessions of Autologous PRP will be administered 15 days apart. Each injection will be 0.5 mL of PRP injected into the Peyronie's disease penile plaque.; Other Names: PRP; Other: Saline Solution; 2 sessions of saline injection will be administered 15 days apart. Each injection will be 0.5 mL of normal saline injected into the Peyronie's disease penile plaque.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects in each group who attain degree change in penile curvature.	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.	7 months
Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).	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).	7 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Ranjith Ramasamy, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: PD; PRP; PyD
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Penile Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Penile Induration; Genital Diseases; Genital Diseases, Male
• Other Study ID Numbers: 20200779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes