Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04036123
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2019-07-19
Brief Title:
Urodynamic Assessment of the Lower Urinary Tract Water vs Air - Synchrony
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Assessment of the Lower Urinary Tract Consistency Features and Artifacts of Invasive Urodynamic Assessments - Synchrony
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison of water-perfused WP and air-charged AC catheters for invasive urodynamic investigation UDI regarding consistency features and artifacts
Detailed Description:
UDI is the gold standard to assess refractory lower urinary tract symptoms LUTS ie to detect and specify lower urinary tract dysfunction LUTD Therefore UDI findings lead to diagnosis and decision-making for further non-invasive and invasive therapies For UDI pressure recordings the use of WP catheters is recommended by the International Continence Society ICS
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-upuse 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 the investigators compare both systems regarding consistency features and artifacts
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-upuse 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 the investigators compare both systems regarding consistency features and artifacts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None