NCT06820606招募中不适用
A Randomized Controlled Trial Comparing Efficacy and Cost Effectiveness of Water Vapour Thermal Therapy (Rezum) and Prostatic Urethral Lift (UroLift) in Men With Benign Prostatic Hyperplasia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
研究概览
简要总结
This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or prostatic urethral lift (UroLift) arm.
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
- •Male ≥ 50 years Symptomatic BPH International prostate symptom score (IPSS) ≥13 Prostate volume 30-80ml
排除标准
- •History or high suspicion of prostate cancer
- •Current urinary tract infection
- •Refractory urinary retention or post-void residual (PVR) ≥250 mL
- •Intravesical prostatic protrusion (IPP)>10mm
- •Prior prostate surgery
- •Known or suspected allergy to nickel, titanium, or polyester/polypropylene
- •Urethral stricture, meatal stenosis, bladder neck contracture
- •Neurogenic bladder and/or sphincter abnormalities
研究组 & 干预措施
Rezum
Active Comparator
干预措施: Rezum (Device)
UroLift
Active Comparator
干预措施: UroLift (Device)
结局指标
主要结局
Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
时间窗: Baseline, 3 months, 6 months and 12 months after intervention
IPSS score ranging from 0-35 (the higher the worse)
次要结局
- Post-op erectile function (MSHQ-EjD-SF)(Baseline, 3 months, 6 months and 12 months after intervention)
- Hospital stays of procedure(From the time patient is hospitalised until the time he discharges)
- Number of days on Foley's catheter or self-catheterization after operation(30 days after intervention)
- Complication rate(30 days after intervention)
- Post-op quality of life score (International Prostate QOL score)(Baseline, 3 months, 6 months and 12 months after intervention)
- Post-op quality of life score (EQ5D-5L questionnaire)(Baseline, 3 months, 6 months and 12 months after intervention)
- Change in voiding function in uroflowmetry (Maximum flow rate)(Baseline, 3 months, 6 months and 12 months after intervention)
- Change in voiding function in uroflowmetry (Post void volume)(Baseline, 3 months, 6 months and 12 months after intervention)
- Post-op erectile function (IIEF-EF)(Baseline, 3 months, 6 months and 12 months after intervention)
- Unplanned readmission rate after operation in 30 days(30 days after intervention)
- Cost of procedure and related hospitalization(At 12 months after treatment)
研究者
CHIU Ka Fung Peter
Professor
Chinese University of Hong Kong
研究点 (1)
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