Clinical trial NCT02756182: Air-charged vs Water-filled Catheters (Bonn)
Official title: Comparison of Air-filled and Water-filled Catheters for Use in Cystometric Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urodynamics
Lead sponsor: Laborie Medical Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 (9M/16F) 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.

Eligibility criteria: Inclusion Criteria:

* Patients normally indicated for urodynamic evaluations

Exclusion Criteria:

* Patients who suffer from bladder infections (not including patients with asymptomatic bacteruria, prophylaxis with an antibiotic is at the discretion of the physician)
* Patients who suffer from strictures in the urethra
* Patients who are pregnant
* Patients who require the use of a suprapubic catheter

Primary outcomes:
measure: Maximum Vesical Pressure During Valsalva Manoeuvres
timeFrame: Measured during a single urodynamic evaluation
measure: Maximum Abdominal Pressure During Valsalva Manoeuvres
timeFrame: Measured during a single urodynamic evaluation
measure: Maximum Detrusor Pressure at Valsalva Manoeuvres
timeFrame: Measured during a single urodynamic evaluation
Secondary outcomes:
measure: Maximum Vesical Pressure During Coughs
timeFrame: Measured during a single urodynamic evaluation
measure: Maximum Abdominal Pressure During Coughs
timeFrame: Measured during a single urodynamic evaluation
measure: Maximum Detrusor Pressure During Coughs
timeFrame: Measured during a single urodynamic evaluation
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Clinic Bonn
Study officials:
References: