Detrusor Contraction During the Ice-water-test

Urinary Bladder, Neurogenic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773213
• Other study ID #: 2012-0400
• Status: Completed
• Phase: N/A
• First received: January 14, 2013
• Last updated: March 2, 2018
• Start date: December 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2018
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuropathic Bladder
• Urinary Bladder, Neurogenic

Intervention

Procedure:
• Ice-water-test

Locations

Country	Name	City	State
Switzerland	Neuro-Urology, Spinal Cord Injury Center & Research, Balgrist University Hospital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensations (yes/no)	Coldness, Urgency, Pain, Information with yes or no	60 minutes
Secondary	Urinary incontinence	Urinary incontinence during the test	60 minutes
Secondary	Heart rate	Assessment of the heart rate during the test	60 minutes