Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02756182
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2016-04-19
Brief Title:
Air-charged vs Water-filled Catheters Bonn
Sponsor:
Laborie Medical Technologies Inc
Organization:
Laborie Medical Technologies Inc
Study Overview
Official Title:
Comparison of Air-filled and Water-filled Catheters for Use in Cystometric Assessment
Status:
COMPLETED
Status Verified Date:
2020-01
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:
A comparative study was conducted and the patient underwent a conventional urodynamic study In order to successfully determine if the Air-Charged AC and Water-Perfused WP measurements are equivalent the two sources of intravesical pressure Pves and abdominal pressure Pabd were collected concurrently at various fill volumes for the bladder
Detailed Description:
The objective of this study was to compare the use of water-filled and air-charged catheters in determining equivalency between the two technologies during cystometric assessment
A total of 25 patients 9M16F were recruited All patients underwent cough and Valsalva manoeuvre pressure tests to measure vesicle pressure Pves and abdominal pressure Pabd A single dual-lumen catheter T-DOC 7Fr Air-Charged catheter was used to record air and water pressures simultaneously
The primary outcome was to determine if the maximum pressures during Valsalva manoeuvres as measured with a single dual-lumen water-perfused and air-charged catheter are equivalent when the bladder is filled to 200 cc during a urodynamic evaluation
Exploratory endpoints included the following
1 To determine if maximum pressures for cough as measured with a single dual-lumen water-perfused and air-charged catheter are equivalent when the bladder is filled to 100 200 and Maximum Bladder Capacity MBC cc during a urodynamic evaluation
2 To determine if maximum pressures for Valsalva manoeuvres as measured with a single dual-lumen water-perfused and air-charged catheter are equivalent when the bladder is filled to 100 and MBC cc during a urodynamic evaluation as well as 200 cc which is the primary objective
3 To determine if the maximum voiding pressure as measured with a single dual-lumen water-perfused and air-charged catheter are equivalent
4 To determine if the clinical impressions of the urodynamic study are equivalent for the water-perfused and air-charged catheters
5 To determine if the compliance of the bladder is equivalent when measured by air-charged catheters as compared to water-perfused catheters
A total of 25 patients 9M16F were recruited All patients underwent cough and Valsalva manoeuvre pressure tests to measure vesicle pressure Pves and abdominal pressure Pabd A single dual-lumen catheter T-DOC 7Fr Air-Charged catheter was used to record air and water pressures simultaneously
The primary outcome was to determine if the maximum pressures during Valsalva manoeuvres as measured with a single dual-lumen water-perfused and air-charged catheter are equivalent when the bladder is filled to 200 cc during a urodynamic evaluation
Exploratory endpoints included the following
1 To determine if maximum pressures for cough as measured with a single dual-lumen water-perfused and air-charged catheter are equivalent when the bladder is filled to 100 200 and Maximum Bladder Capacity MBC cc during a urodynamic evaluation
2 To determine if maximum pressures for Valsalva manoeuvres as measured with a single dual-lumen water-perfused and air-charged catheter are equivalent when the bladder is filled to 100 and MBC cc during a urodynamic evaluation as well as 200 cc which is the primary objective
3 To determine if the maximum voiding pressure as measured with a single dual-lumen water-perfused and air-charged catheter are equivalent
4 To determine if the clinical impressions of the urodynamic study are equivalent for the water-perfused and air-charged catheters
5 To determine if the compliance of the bladder is equivalent when measured by air-charged catheters as compared to water-perfused catheters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None