Urinary Bladder, NeurogenicNCT01773213
Detrusor Contraction During the Ice-water-test
A study testing Ice-water-test in people with Urinary Bladder, Neurogenic and Neuropathic Bladder, run by Balgrist University Hospital at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Urinary Bladder, Neurogenic, Neuropathic Bladder
- What is being tested?
- Ice-water-test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neurogenic lower urinary tract dysfunction
- urodynamic investigation
- written informed consent
- ≥ 18 years old
Who cannot join
- symptomatic urinary tract infection
- < 18 years old
- ≥ 90 years old
- no written informed consent
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Neuro-Urology, Spinal Cord Injury Center & Research, Balgrist University Hospital
Zurich, 8008
About this study
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
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.
Read the 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.
- Conditions
- Urinary Bladder, Neurogenic, Neuropathic Bladder
- Being tested
- Ice-water-test
- Keywords
- Lower urinary tract, Bladder, Neuropathic bladder, Overactive bladder
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice-water-testProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bladder dysfunction, ice-water-test | Other | Not described Receives: Procedure: Ice-water-test |
| Bladder dysfunction, warm water-test | Other | Not described Receives: Procedure: Ice-water-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 60 minutes
Secondary outcomes (3)
Sensations (yes/no)
Coldness, Urgency, Pain, Information with yes or no
Measured: 60 minutes
Urinary incontinence
Urinary incontinence during the test
Measured: 60 minutes
Heart rate
Assessment of the heart rate during the test
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, NeurogenicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kessler, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773213
- Sponsor's protocol ID
- 2012-0400
- Status last verified
- Mar 2018
- First submitted
- 14 Jan 2013
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01773213
- Acronym / sponsor ID
- 2012-0400
- Conditions
- Urinary Bladder, Neurogenic, Neuropathic Bladder
- Keywords
- Lower urinary tract, Bladder, Neuropathic bladder, Overactive bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder dysfunction, ice-water-test | Other | Procedure: Ice-water-test |
| Bladder dysfunction, warm water-test | Other | Procedure: Ice-water-test |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- neurogenic lower urinary tract dysfunction
- urodynamic investigation
- written informed consent
- ≥ 18 years old
Key exclusion criteria (5 listed)
- symptomatic urinary tract infection
- < 18 years old
- ≥ 90 years old
- no written informed consent
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice-water-test | Procedure or surgery | Bladder dysfunction, ice-water-test, Bladder dysfunction, warm water-test |
Primary outcome
Increase of detrusor pressure in cmH20
Time frame: 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)
3 secondary outcomes
Sensations (yes/no)
Time frame: 60 minutes
Urinary incontinence
Time frame: 60 minutes
Heart rate
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice-water-test in people with Urinary Bladder, Neurogenic and Neuropathic Bladder, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase of detrusor pressure in cmH20 (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.