PRP for Treatment of Peyronie's Disease

University of Miami65 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

Autologous Platelet Rich PlasmaDRUG

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.

Saline SolutionOTHER

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 7 months

Secondary Outcomes

Incidence of adverse events in all patients

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

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

Data from ClinicalTrials.gov

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