Detrusor Contraction During the Ice-water-test

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas M Kessler, Balgrist University Hospital
ClinicalTrials.gov Identifier:
NCT01773213
First received: January 14, 2013
Last updated: July 11, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Urinary Bladder, Neurogenic
Neuropathic Bladder
Procedure: Ice-water-test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Balgrist University Hospital:

Primary Outcome Measures:
  • Increase of detrusor pressure in cmH20 [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Sensations (yes/no) [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Coldness, Urgency, Pain, Information with yes or no

  • Urinary incontinence [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Urinary incontinence during the test

  • Heart rate [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Assessment of the heart rate during the test


Enrollment: 40
Study Start Date: December 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bladder dysfunction, ice-water-test Procedure: Ice-water-test

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773213

Locations
Switzerland
Neuro-Urology, Spinal Cord Injury Center & Research, Balgrist University Hospital
Zürich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
  More Information

No publications provided

Responsible Party: Thomas M Kessler, executive physician, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT01773213     History of Changes
Other Study ID Numbers: 2012-0400
Study First Received: January 14, 2013
Last Updated: July 11, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Balgrist University Hospital:
Lower urinary tract
Bladder
Neuropathic bladder
Overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014