PRP for Treatment of Peyronie's Disease

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04512287

Collaborator

(none)

Enrollment

Location

Arms

24.1

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Peyronie Disease Sexual Dysfunction, Physiological Sexual Dysfunction Male Genital Diseases, Male	Drug: Autologous Platelet Rich Plasma Other: Saline Solution	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 29, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Ranjith Ramasamy, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ranjith Ramasamy, MD, Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04512287

Other Study ID Numbers:

20200779

First Posted:

Aug 13, 2020

Last Update Posted:

Apr 21, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

Keywords provided by Ranjith Ramasamy, MD, Professor, University of Miami

PyD

PRP

Additional relevant MeSH terms:

Penile Induration

Sexual Dysfunction, Physiological

Study Results

No Results Posted as of Apr 21, 2022