C.L.E.A.R. - Comparing UroLift Experience Against Rezūm
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Catheter Independent
研究概览
简要总结
C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.
详细描述
Patients will be randomized to either the UroLift or Rezum arm. Post-procedure, subjects who receive a catheter between post-procedure and prior to discharge, will return to office to complete a voiding assessment.
All subjects will be expected to complete questionnaires and assessments, as part of SOC (varies by institution), at day 3, day 7, 2 weeks, 1 month, 3 months and 12 months post-procedure.
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
- 是
入选标准
- •Male gender
- •Age ≥ 50 years
- •Diagnosis of symptomatic BPH
- •Prostate volume 30cm3 ≤ 80cm3
- •Willing to sign study informed consent form
排除标准
- •Current urinary tract infection
- •Current catheter dependent urinary retention or PVR >= 500 mL
- •Urethra conditions that may prevent insertion of delivery system into bladder
- •Previous BPH surgical procedure
- •Urinary incontinence presumed due to incompetent sphincter
- •Current gross hematuria
- •Patients with a urinary sphincter implant
- •Patients who have a penile prosthesis
- •Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
研究组 & 干预措施
UroLift
Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure.
干预措施: UroLift (Device)
Rezūm
Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure.
干预措施: Rezum (Device)
结局指标
主要结局
Catheter Independent
时间窗: Through 1-week
Number of subjects who are catheter independent and remain catheter independent through 1-week
次要结局
未报告次要终点