RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- To identify responders of IPSS change
研究概览
简要总结
The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of symptomatic BPH
排除标准
- •Prior surgical intervention for treatment of BPH
- •Unable or unwilling to give informed consent or unwilling to complete all required questionnaires and follow-up assessments
研究组 & 干预措施
UroLift System
Therapy to be treatment with the UroLift System.
干预措施: UroLift System (Device)
Watchful Waiting or BPH Medications
Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications.
干预措施: Watchful Waiting or BPH Medications (Other)
Other Surgical Intervention
Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.
干预措施: Other Surgical Intervention (Device)
结局指标
主要结局
To identify responders of IPSS change
时间窗: 3 months post-treatment visit
Change of \>3 points in IPSS score from baseline to the 3 months post-treatment visit.
次要结局
未报告次要终点