Air-charged vs Water-filled Catheters (Bonn)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Urodynamics

Clinical Trial Details

NCT number	NCT02756182
Study type	Interventional
Source	Laborie Medical Technologies Inc.
Contact
Status	Completed
Phase	N/A
Start date	April 27, 2016
Completion date	August 22, 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.