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临床试验/NCT01773213
NCT01773213已完成不适用

Is the Detrusor Contraction During the Ice-water-test Provoked by the Ice Water or the Rapid Bladder Filling? A Randomized, Double-blind Clinical Trial

Balgrist University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Increase of detrusor pressure in cmH20

研究概览

简要总结

In this randomized, double-blind clinical trial including patients with a neurogenic lower urinary tract dysfunction undergoing urodynamic investigation at the Spinal Cord Injury Center, Balgrist University Hospital, Zürich, we aim to investigate whether the detrusor contraction during the ice-water-test is provoked by the ice water or the rapid filling.

详细描述

The ice-water-test (IWT) was first described 1957 by Bors and Blinn and it was thought to differentiate between lesions of the upper and lower motoneuron. In cat studies, it was shown that the IWT is a C-fiber mediated lower motoneuron segmental reflex and that these unmyelinated C fibers are associated with cold receptors. This explains the positive IWT in patients with upper motoneuron lesions. In healthy humans, the IWT is positive up to the age of 4 years and becomes negative thereafter since the reflex is centrally inhibited. However, this reflex might be unmasked by a neurological disease and/or injury.

Considering that C-fibers are involved in the pathogenesis of detrusor overactivity, the IWT seems to be a useful diagnostic tool in daily practice. However, although there are many studies published on the IWT, it is unclear whether the detrusor contraction during the IWT is provoked by the ice water or whether it might be caused by the rapid filling. Therefore, we designed this randomized, double-blind trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • neurogenic lower urinary tract dysfunction
  • urodynamic investigation
  • written informed consent
  • ≥ 18 years old

排除标准

  • symptomatic urinary tract infection
  • < 18 years old
  • ≥ 90 years old
  • no written informed consent
  • pregnancy

研究组 & 干预措施

Bladder dysfunction, ice-water-test

Other

干预措施: Ice-water-test (Procedure)

Bladder dysfunction, warm water-test

Other

干预措施: Ice-water-test (Procedure)

结局指标

主要结局

Increase of detrusor pressure in cmH20

时间窗: 60 minutes

Increase of detrusor pressure during the verum ice-water-test and the placebo ice-water-test (intravesical pressure increase during the filling of the bladder with 4°C or 36°C water)

次要结局

  • Urinary incontinence(60 minutes)
  • Sensations (yes/no)(60 minutes)
  • Heart rate(60 minutes)

研究者

发起方
Balgrist University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Kessler

executive physician

Balgrist University Hospital

研究点 (2)

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