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临床试验/NCT02594631
NCT02594631Unknown4 期

Shock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.

Mansoura University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
Stone free rate

研究概览

简要总结

The aim of the study is to compare the safety and efficacy of ESWL and visual cystolitholapaxy in management of calcular acute urine retention.

详细描述

Patients who present with acute urinary retention due to stone in the urethra or urinary bladder will be randomly assigned to receive treatment either by extracorporeal shock wave lithotripsy or by endoscopic visual cystolitholapaxy where patients and stone characteristics will be recorded and the outcome including the intraoperative and postoperative complications and the stone free rate will be also evaluated

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
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Adult male patients presenting with acute urinary retention due to urethral or urinary bladder stones.
  • •with a stone size not more than 2 centimeters in greatest diameter.
  • •No more than 2 stones.

排除标准

  • •Bladder cancer.
  • •Bladder replacement of any type.
  • •Infravesical obstruction, due to marked benign prostatic hyperplasia, prostate cancer, stricture urethra or external urethral meatal stenosis.

研究组 & 干预措施

ESWL Group

Active Comparator

Patients in this arm will receive ESWL as treatment for acute calcular urinary retention

干预措施: ESWL (Procedure)

Endoscopy group

Active Comparator

Patients in this arm will receive endoscopic treatment for acute calcular urinary retention

干预措施: Endoscopic treatment (Procedure)

结局指标

主要结局

Stone free rate

时间窗: 1 week

evaluation of stone free rate after the assigned intevention

次要结局

  • Adverse events after the assigned intervention(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ali

Resident in Urology, Urology and Nephrology Center, Mansoura University

Mansoura University

研究点 (1)

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