Skip to main content
OpenTrials
Completed

NCT Number: NCT04512287

PRP 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peyronie Disease Connective Tissue Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Penile Induration Sexual Dysfunction Male Sexual Dysfunction, Physiological Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Platelet Rich Plasma

Drug

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

Saline solution

Other

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 outcomes

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Incidence of adverse events in all patients

    Time frame: Baseline, 6 months (post-intervention)

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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2020
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.