The Role of Platelet Rich Plasma for Erectile Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Erectile Function Change
研究概览
简要总结
Purpose of Study: This randomized controlled trial investigates the role that platelet rich plasma injections into the penis may play to improve erectile function in men with erectile dysfunction.
详细描述
Eligibility: Men with erectile dysfunction. Ages 50-80. International Index of Erectile Function score of mild (17-21/25) or moderate (8-16/25).
Intervention and Evaluation:Men who consent to join the trial will be randomized to receive either a single injection PRP or saline to the penis. All patients will have blood drawn in clinic the day of injection. Those randomized to PRP arm will have their own blood prepared and separated into the PRP. This solution of their own blood will be injected back into the penis.
Follow Up: Men will be evaluated at 1 , 3, and 6 months after the injections and then asked to complete the IIEF by phone or by electronic means
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •history of mild to moderate erectile dysfunction measured by IIEF
排除标准
- •history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)
结局指标
主要结局
Erectile Function Change
时间窗: at 1, 3 and 6 months
The rate of change in erectile function measured by IIEF
次要结局
未报告次要终点