Air-charged vs Water-filled Catheters (Bonn)

Laborie Medical Technologies

Status: Completed

Conditions: Urodynamics

Treatments: Device: TDOC air-charged catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02756182

AvW-Bonn-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Urodynamics with AC and WP

Experimental group

Description:

Patients underwent a conventional urodynamics study utilizing a single catheter technique

Treatment:

Device: TDOC air-charged catheter