Air-charged vs Water-filled Catheters (Bonn)

Not Applicable

Completed

Conditions: Urodynamics

Interventions: Device: TDOC air-charged catheter

Registration Number: NCT02756182

Lead Sponsor: Laborie Medical Technologies Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urodynamics with AC and WP	TDOC air-charged catheter	Patients underwent a conventional urodynamics study utilizing a single catheter technique

Primary Outcome Measures

Name	Time	Method
Maximum Vesical Pressure During Valsalva Manoeuvres	Measured during a single urodynamic evaluation	Maximum vesical pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Maximum Abdominal Pressure During Valsalva Manoeuvres	Measured during a single urodynamic evaluation	Maximum abdominal pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Maximum Detrusor Pressure at Valsalva Manoeuvres	Measured during a single urodynamic evaluation	Maximum detrusor pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.

Secondary Outcome Measures

Name	Time	Method
Maximum Vesical Pressure During Coughs	Measured during a single urodynamic evaluation	Maximum vesical pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Maximum Abdominal Pressure During Coughs	Measured during a single urodynamic evaluation	Maximum abdominal pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Maximum Detrusor Pressure During Coughs	Measured during a single urodynamic evaluation	Maximum detrusor pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.