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PRP for Treatment of Peyronie's Disease

Primary Purpose

Peyronie Disease, Sexual Dysfunction, Physiological, Sexual Dysfunction Male

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Autologous Platelet Rich Plasma

Saline Solution

About this trial

This is an interventional treatment trial for Peyronie Disease focused on measuring PD, PyD, PRP

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental: Autologous PRP followed by Placebo Group

Experimental: Placebo followed by Autologous PRP Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

Incidence of adverse events in all patients

Safety will be evaluated via the incidence of adverse events as assessed by treating physician

Full Information

NCT ID

NCT04512287

First Posted

August 11, 2020

Last Updated

November 21, 2022

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT04512287

Brief Title

PRP for Treatment of Peyronie's Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 29, 2021 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peyronie Disease, Sexual Dysfunction, Physiological, Sexual Dysfunction Male, Genital Diseases, Male

Keywords

PD, PyD, PRP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Autologous PRP followed by Placebo Group

Arm Type

Experimental

Arm Description

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

Arm Title

Experimental: Placebo followed by Autologous PRP Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Autologous Platelet Rich Plasma

Other Intervention Name(s)

PRP

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Saline Solution

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of subjects in each group who attain degree change in penile curvature.

Description

Time Frame

7 months

Title

Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).

Description

Time Frame

7 months

Secondary Outcome Measure Information:

Title

Incidence of adverse events in all patients

Description

Safety will be evaluated via the incidence of adverse events as assessed by treating physician

Time Frame

Baseline, 6 months (post-intervention)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kevin Chu, MD

Phone

305-243-4562

kevin.chu@jhsmiami.org

First Name & Middle Initial & Last Name or Official Title & Degree

Ranjith Ramasamy, MD

Phone

305-243-4562

ramasamy@miami.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ranjith Ramasamy, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kevin Chu, MD

Phone

305-243-4562

kevin.chu@jhsmiami.org

First Name & Middle Initial & Last Name & Degree

Ranjith Ramasamy, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

PRP for Treatment of Peyronie's Disease

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