Detrusor Contraction During the Ice-water-test

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Urinary Bladder, Neurogenic, Neuropathic Bladder

Intervention / Treatment
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* Procedure: Ice-water-test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: neurogenic lower urinary tract dysfunction urodynamic investigation written informed consent ≥ 18 years old Exclusion Criteria: symptomatic urinary tract infection < 18 years old ≥ 90 years old no written informed consent pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bladder dysfunction, ice-water-test<br> | Procedure: Ice-water-test<br> <br> |
| Other: Bladder dysfunction, warm water-test<br> | Procedure: Ice-water-test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of detrusor pressure in cmH20 | 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) | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensations (yes/no) | Coldness, Urgency, Pain, Information with yes or no | 60 minutes | 
| Urinary incontinence | Urinary incontinence during the test | 60 minutes | 
| Heart rate | Assessment of the heart rate during the test | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower urinary tract, Bladder, Neuropathic bladder, Overactive bladder