L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 14
- 主要终点
- Quality of Recovery
研究概览
简要总结
The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.
详细描述
The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving the investigational device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)
排除标准
- •Size, volume,length of prostate
研究组 & 干预措施
UroLift® System
Single-arm of qualified subjects receiving UroLift® System intervention.
干预措施: UroLift® System (Device)
结局指标
主要结局
Quality of Recovery
时间窗: 1 Month
Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.
次要结局
- IPSS 12 Month Percent (%) Change From Baseline(12 Months)
- QMAX 12 Month Change Minus Baseline(12 Months)
- BPHII Baseline and 12 Month Median Score, 95% CI(12 Month)
- IPSS Scores at Baseline and 12 Month Follow-up(12 Months)
- BPH II 12 Month Percent (%) Change From Baseline(12 Months)
- Qmax Scores at Baseline and 12 Month Follow-up(12 Month)
- QMAX 12 Month Percent (%) Change in mL/Sec From Baseline(12 Months)
- IPSS 12 Month Change From Baseline(12 Months)
- BPH II Scores at Baseline and 12 Month Follow-up(12 Month)
- IPSS at Baseline and 12 Months, Median , 95% CI(12 Month)
- BPH II 12 Month Change From Baseline(12 Months)
- Pain Tolerability Throughout the UroLift System Procedure(12 Month)
- QMAX Median at Baseline and 12 Months With CI 95%(12 Month)