4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- percentage of participants with normal erectile dysfunction
研究概览
简要总结
The purpose of this study is to see if the study drug 4-aminopyridine (4-AP) can help speed up the recovery of peripheral nerve injury after prostatectomy. 4-AP is a potassium channel blocker used to improve walking in multiple sclerosis patients. Investigators will measure the effect that 4-AP may have on the recovery of sexual function and urinary incontinence after prostatectomy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
4-aminopyridine
Participants with recent prostatectomies receiving 4-aminopyridine
干预措施: 4-aminopyridine (Drug)
Placebo
Participants with recent prostatectomies receiving placebo
干预措施: placebo (Drug)
结局指标
主要结局
percentage of participants with normal erectile dysfunction
时间窗: 2 months
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
次要结局
- percentage of participants with normal erectile dysfunction(week 24)
- the time point at which the highest number of subjects reporting normal erectile dysfunction(baseline to month 12)
- percentage of participants with normal urinary continence(2 months)
研究者
Ahmed Ghazi
Assistant Professor
University of Rochester