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
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
- 否
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
干预措施: Ice-water-test (Procedure)
Bladder dysfunction, warm water-test
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
Thomas Kessler
executive physician
Balgrist University Hospital
