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临床试验/NCT02942641
NCT02942641已完成不适用

Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention: A Prospective Randomized Trial

Ramathibodi Hospital0 个研究点目标入组 100 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
Catheter-associated urinary tract infection (CAUTI)

研究概览

简要总结

Objective: Acute urinary retention (AUR) is a common problem in hospitalized patients. Either indwelling urethral catheterization or clean intermittent catheterization (CIC) can be the choice of treatment. In chronic urinary retention, most physicians prefer CIC to chronic indwelling urethral catheter on the basis of the claim that the rate of catheter-associated urinary tract infection (CAUTI) is lower.

Method: The patients were randomized into indwelling urethral catheter and CIC groups. The primary outcomes of the study were catheter-associated asymptomatic bacteriuria and CAUTI. The secondary outcomes were pain, hematuria, cloudy urine, and quality of life.

详细描述

We queried the hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June 2014 to May 2015. Patients under 18 years of age with a history of urinary retention, urinary tract infection, and poor compliance were excluded from this study. All the patients gave their written informed consents. The patients were randomly divided into two groups depending on the type of assigned intervention: CIC and indwelling urethral catheter groups.

All the patients were followed up after 2 weeks; urinalysis and urine culture were obtained at the time of AUR and whenever the patients developed UTI-associated symptoms. The patients with positive urine culture at the time of AUR were excluded from the study.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June 2014 to May 2015.

排除标准

  • Patients under 18 years of age
  • History of urinary retention
  • Urinary tract infection
  • Poor compliance

结局指标

主要结局

Catheter-associated urinary tract infection (CAUTI)

时间窗: up to 12 months

the presence of symptoms or signs compatible with UTI and no other identified source of infection, along with ≥103 CFU/mL of ≥1 bacterial species in a single catheter urine specimen or in a midstream voided urine specimen from a patient whose urethral catheter has been removed within the previous 48 hours.

次要结局

  • Cloudy urine(up to 12 months)
  • Quality of life(up to 12 months)
  • Hematuria(up to 12 months)
  • Catheter-associated asymptomatic bacteriuria(up to 12 months)
  • Pain(up to 12 months)

研究者

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

Dr. Pocharapong Jenjitranant

Dr. Pocharapong Jenjitranant

Ramathibodi Hospital

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