Urodynamic Assessment of the Lower Urinary Tract: Water vs. Air
NCT ID: NCT04033770
Last Updated: 2022-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
490 participants
INTERVENTIONAL
2021-02-01
2022-02-11
Brief Summary
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Detailed Description
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Currently AC catheters have been marked for pressure recording as an alternative to WP catheters. However, the number of comparative studies is very limited. Nevertheless, since release, AC catheters have gained popularity due to their omnidirectional detection of pressure, and claimed reduction in movement artefacts (due to weight-less air column vs weighted water column), lack of external reference level, and ease of set-up/use. Still, there is debate whether AC catheters are an acceptable alternative to fluid-filled lines for measuring intravesical and intra-abdominal pressure in UDI. Based on the available literature, an appropriate conclusion, whether both systems can be used as equivalents and interchangeably, cannot be drawn.
In this study we compare both systems regarding consistency, features and artifacts.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Air-charged measurement system
UDI (same session repeat filling cystometry and pressure flow study) according to "Good Urodynamic Practice" recommended by the ICS but using an air-charged instead of a water-filled measurement system.
Urodynamic investigation
Urodynamic investigation using an air-charged measurement system
Water-perfused measurement system
UDI (same session repeat filling cystometry and pressure flow study) according to "Good Urodynamic Practice" recommended by the ICS.
Urodynamic investigation
Urodynamic investigation using a water-perfused measurement system
Interventions
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Urodynamic investigation
Urodynamic investigation using an air-charged measurement system
Urodynamic investigation
Urodynamic investigation using a water-perfused measurement system
Eligibility Criteria
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Inclusion Criteria
* Age: minimum 18 years
* Informed consent
* Competent German language skills
Exclusion Criteria
* Pregnancy or breast feeding (see chapter 3.6.)
* Symptomatic UTI
* Individuals especially in need of protection
* No informed consent
* Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on.
* Earlier participation in this clinical trial
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Locations
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Universitätsklinik Balgrist
Zurich, , Switzerland
Countries
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Other Identifiers
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UDI-RCT 2018-00073
Identifier Type: -
Identifier Source: org_study_id
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