A Randomized, Double-Blind, Placebo Controlled, Crossover Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma for Treatment of Peyronie's Disease
Overview
- Phase
- Phase 2
- Intervention
- Autologous Platelet Rich Plasma
- Conditions
- Peyronie Disease
- Sponsor
- University of Miami
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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).
Investigators
Manuel Molina Leyba
Research Physician
University of Miami
Eligibility Criteria
Inclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Autologous Platelet Rich Plasma
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.
Intervention: Saline Solution
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.
Intervention: Autologous Platelet Rich Plasma
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.
Intervention: Saline Solution
Outcomes
Primary Outcomes
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).
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.
Secondary Outcomes
- Incidence of adverse events in all patients(Baseline, 6 months (post-intervention))