NCT05762198已完成不适用
A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP in Men With Benign Prostatic Hyperplasia in Refractory Urinary Retention
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 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 transurethral resection of prostate (TURP) 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 50-80 years
- •Refractory urinary retention related to benign prostatic hyperplasia (BPH)
- •On urethral Foley's catheter before treatment
- •Prostate size 30-80ml on ultrasound
排除标准
- •Prior prostate operation
- •Past or current history of prostate cancer
- •Strong suspicion of prostate cancer (e.g. Elevated PSA before urinary retention or abnormal prostate on DRE without workup for prostate cancer)
- •Known Urethral stricture / Bladder stone / Hypocontractile bladder
- •Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke)
- •Contraindicated to undergo TURP or REZUM (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)
研究组 & 干预措施
Rezūm
Active Comparator
干预措施: Rezūm (Device)
TURP
Active Comparator
干预措施: TURP (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
- Complication rate(30 days after intervention)
- Successful trial without catheter (TWOC) within 3 months(At 3 months)
- Post-op quality of life score(Baseline, 3 months, 6 months and 12 months after intervention)
- Unplanned readmission rate after operation in 30 days(30 days after intervention)
- Change in voiding function in uroflowmetry(Baseline, 3 months, 6 months and 12 months after intervention)
- Post-op International Index of Erectile function score(Baseline, 3 months, 6 months and 12 months after intervention)
- Hospital stays of procedure(On Discharge)
研究者
CHIU Ka Fung Peter
Professor
Chinese University of Hong Kong
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A randomized controlled trial for the comparison of the bleeding during hepatectomy with and without clamping the inferior vena cava below the liver.The patient who need open hepatectomy.JPRN-UMIN000003317Yokohama city university graduate school of medicine200
已完成
不适用
A randomized controlled trial for the comparison of the benefit of preoperative supplementation of a branched chain amino acid (BCAA) granules for patients undergoing liver resection for hepatocellular carcinoma.Hepatocellular carcinomaJPRN-UMIN000004244Yokohama city university graduate school of medicine80
已完成
3 期
A randomized controlled trial for the comparison of radiofrequency ablation with and without transcatheter arterial chemoembolization for patients with hepatocellular carcinomahepatocellular carcinomaJPRN-UMIN000002083Yokohama City University Medical Center Gastroenterological Center40
招募中
1 期
Personalized dosing of immunosuppression after kidney transplantation by measuring the immune system functionalityPost Kidney transplantationMedDRA version: 21.1Level: LLTClassification code: 10050436Term: Prophylaxis against renal transplant rejection Class: 10042613CTIS2022-500024-30-00Medical University Of Vienna260
招募中
不适用
The utility of bile duct stent placement in liver transplantatioBiliary complicationsliver transplantSurgery - Surgical techniquesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonACTRN12619000776101Princess Alexandra Hospital80