BPH-6: A UroLift® System Post Market Multi-Center Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 14
- 主要终点
- Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met
研究概览
简要总结
The purpose of this study is to compare the UroLift System Treatment to Transurethral Resection of the Prostate (TURP) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.
详细描述
The study is a prospective, consecutive, multi-center, 1:1 randomized study (UroLift System:TURP). The study is intended to be conducted at up to 20 different centers in Europe and Canada to enroll up to 100 subjects.
Subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men >50 years old with moderate-severe BPH
排除标准
- •Size, width of prostate
- •Other medical condition or co-morbidity contraindicative for TURP or UroLift
研究组 & 干预措施
UroLift System
UroLift System procedure
干预措施: UroLift System (Device)
Transurethral Resection of the Prostate
Transurethral Resection of the Prostate surgery
干预措施: Transurethral Resection of the Prostate (Procedure)
结局指标
主要结局
Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met
时间窗: Month 12
1. LUTS: ≥ 30% reduction in IPSS compared to baseline 2. Recovery Experience: Return to pre-operative activity levels by 1 month 3. Erectile function: Less than 6-point reduction in SHIM compared to baseline. 4. Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response "Could not ejaculate" 5. Continence: ISI score of 4 points or less at all follow-up time points 6. Safety: No procedure-related adverse event greater than Grade I on the Clavien-Dindo classification system modified for TURP at any time during procedure or follow up.
次要结局
未报告次要终点