A Randomized, Double-Blind, Placebo Controlled, Crossover Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma for Treatment of Peyronie's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
研究概览
简要总结
The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
时间窗: 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.
时间窗: 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.
次要结局
- Incidence of adverse events in all patients(Baseline, 6 months (post-intervention))
研究者
Manuel Molina Leyba
Research Physician
University of Miami