Comparison of Air Charged Catheters With Water Filled Catheters for Urodynamic Study (ACWF)
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|ClinicalTrials.gov Identifier: NCT02030340|
Recruitment Status : Unknown
Verified January 2014 by Peter F.W.M. Rosier, UMC Utrecht.
Recruitment status was: Recruiting
First Posted : January 8, 2014
Last Update Posted : January 8, 2014
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.
|Condition or disease||Intervention/treatment|
|Incontinence||Procedure: lower urinary tract dysfunction|
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 parameters/endpoints: 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 Type :||Observational|
|Estimated Enrollment :||36 participants|
|Official Title:||In Vivo Comparison of Air Charged Catheters With Water Filled Catheters for Intravesical and Intrarectal Pressures Recording During Urodynamic Study|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||December 2014|
Testing Lower urinary tract dysfunction
All patients with lower urinary tract dysfunction where urodynamic diagnosis is required according to standards and (international) practice guidelines will have a synchronous double system (combination of air-charged and water filled) urodynamic test.
Procedure: lower urinary tract dysfunction
Urodynamic investigation with a double (two systems: air-charged and water filled) catheter system
Other Name: T-doc air charged catheters.
- The difference between the water filled catheter recorded and simultaneously air charged catheter recorded maximum pressure (amplitude)during the bladder filling phase of urodynamic test. [ Time Frame: acute comparison during one test with two types of catheter ]Null hypothesis: the (absolute mean) difference between the water filled catheter recorded and simultaneously air charged catheter recorded maximum pressure (amplitude) observed with a dominant detrusor pressure event during urodynamic filling as obtained with both systems is close to zero.
- responses to relevant pressure events: end fill pressure, maximum contraction pressure, maximum pressure at overactive detrusor contraction and maximum cough pressure. [ Time Frame: acute comparison during one test with two types of catheter ]to test the clinical feasibility (-mean absolute- pressure responses differences) of the air charged system, against the contemporary clinical standard. Perfect feasibility of air charged catheter system is achieved when the measured pressures are equal (difference zero) to the water filled system in all performed measurements in all situations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030340
|Contact: Peter FW Rosier, MD PhDfirstname.lastname@example.org|
|Contact: Ruud JL Bosch, Prof.||+31887558081||J.L.H.R.Bosch@umcutrecht.nl|
|University Medical Center Utrecht||Recruiting|
|Utrecht, Netherlands, 3584CX|
|Principal Investigator: Peter FW Rosier, MD PhD|
|Principal Investigator:||Peter FW Rosier, MD PhD||University Medical Center Utrecht, the Netherlands|