A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 131
- 主要终点
- Erectile Function Domain Score Between Treated and Untreated Groups
研究概览
简要总结
The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.
详细描述
The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.
排除标准
- •Patient is > 65 years of age
- •Patient has been diagnosed with Type 1 or Type 2 diabetes
- •Patient is actively smoking on a daily basis
研究组 & 干预措施
Tacrolimus
Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
干预措施: Tacrolimus (Drug)
Placebo
Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
干预措施: Placebo (Drug)
结局指标
主要结局
Erectile Function Domain Score Between Treated and Untreated Groups
时间窗: 18 months
Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.
次要结局
- Percentage of Patients Considered Successful Responders to Impotence Medications(24 months)
- Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score(24 months)
- Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score(24 months)
- Time to Achieve Response to Impotence Medications(24 months)
- Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire(24 months)