Ignite Creation Date:
2024-05-06 @ 2:23 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02030340
Status:
UNKNOWN
Last Update Posted:
2014-01-08
First Post:
2013-03-06
Brief Title:
Comparison of Air Charged Catheters With Water Filled Catheters for Urodynamic Study
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
In Vivo Comparison of Air Charged Catheters With Water Filled Catheters for Intravesical and Intrarectal Pressures Recording During Urodynamic Study
Status:
UNKNOWN
Status Verified Date:
2014-01
Last Known Status:
RECRUITING
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:
ACWF
Brief Summary:
Various systems to measure intravesical and intrarectal pressure during urodynamic testing especially cystometry exist Water filled tube -systems are the most commonly used and should be regarded as the contemporary standard A water filled system is however sensitive to tube and or patient movement artefacts and prone to erroneous calibration Air charged catheters are less sensitive to patient and especially tubing- movements and calibrate easier However in vitro tests have demonstrated that air charged catheters respond somewhat slower and relatively damped especially to rapid pressure changes as in simulated coughing in comparison with water filled systems The clinical relevance of these observations is unknown
This is a study to compare the technical reliability and clinical applicability of the two types of catheter systems for cystometry in a synchronous double catheter testing procedure in a prospective group or patients scheduled for urodynamic investigation
This is a study to compare the technical reliability and clinical applicability of the two types of catheter systems for cystometry in a synchronous double catheter testing procedure in a prospective group or patients scheduled for urodynamic investigation
Detailed Description:
Study design Patient cohort acute experiment mono -center synchronous double urodynamic catheter technique study
Study population Adult female patients and male or female patients with spinal cord injury or meningomyelocele unable to void scheduled for urodynamic investigation on the basis of contemporary standards and guidelines because of signs and or symptoms of lower urinary tract dysfunction
Intervention Synchronous double catheter urodynamic testing Standard filling cystometry with both air-charged ánd water filled catheter pairwise inserted and connected to the registry equipment
Main study parametersendpoints Difference of intravesical pressure increment maximum during filling cystometry between the two systems
Primary hypothesis to test The average difference as well as the average absolute difference of maximum water pressure standard system and maximum air pressure comparator are both 0 zero
There is no per-protocol for follow up of the patients
Study population Adult female patients and male or female patients with spinal cord injury or meningomyelocele unable to void scheduled for urodynamic investigation on the basis of contemporary standards and guidelines because of signs and or symptoms of lower urinary tract dysfunction
Intervention Synchronous double catheter urodynamic testing Standard filling cystometry with both air-charged ánd water filled catheter pairwise inserted and connected to the registry equipment
Main study parametersendpoints Difference of intravesical pressure increment maximum during filling cystometry between the two systems
Primary hypothesis to test The average difference as well as the average absolute difference of maximum water pressure standard system and maximum air pressure comparator are both 0 zero
There is no per-protocol for follow up of the patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| T-Doc-LLC | OTHER_GRANT | T-Doc-LLC Wilmington USA | None |