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Detrusor Contraction During the Ice-water-test

Primary Purpose

Urinary Bladder, Neurogenic, Neuropathic Bladder

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ice-water-test
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Urinary Bladder, Neurogenic focused on measuring Lower urinary tract, Bladder, Neuropathic bladder, Overactive bladder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neuro-Urology, Spinal Cord Injury Center & Research, Balgrist University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Bladder dysfunction, ice-water-test

Bladder dysfunction, warm water-test

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Sensations (yes/no)
Coldness, Urgency, Pain, Information with yes or no
Urinary incontinence
Urinary incontinence during the test
Heart rate
Assessment of the heart rate during the test

Full Information

First Posted
January 14, 2013
Last Updated
March 2, 2018
Sponsor
Balgrist University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01773213
Brief Title
Detrusor Contraction During the Ice-water-test
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balgrist University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Neurogenic, Neuropathic Bladder
Keywords
Lower urinary tract, Bladder, Neuropathic bladder, Overactive bladder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bladder dysfunction, ice-water-test
Arm Type
Other
Arm Title
Bladder dysfunction, warm water-test
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Ice-water-test
Primary Outcome Measure Information:
Title
Increase of detrusor pressure in cmH20
Description
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)
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Sensations (yes/no)
Description
Coldness, Urgency, Pain, Information with yes or no
Time Frame
60 minutes
Title
Urinary incontinence
Description
Urinary incontinence during the test
Time Frame
60 minutes
Title
Heart rate
Description
Assessment of the heart rate during the test
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Neuro-Urology, Spinal Cord Injury Center & Research, Balgrist University Hospital
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

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Detrusor Contraction During the Ice-water-test

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