Air-charged vs Water-filled Catheters (Bonn)

NCT ID: NCT02756182

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-27
• Study Completion Date: 2016-08-22

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.

Conditions

Urodynamics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Urodynamics with AC and WP

Patients underwent a conventional urodynamics study utilizing a single catheter technique

Group Type: EXPERIMENTAL

TDOC air-charged catheter

Intervention Type: DEVICE

Urodynamic study utilizing a single catheter technique to measure WP \& AC measurements

Interventions

TDOC air-charged catheter

Urodynamic study utilizing a single catheter technique to measure WP \& AC measurements

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laborie Medical Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Clinic Bonn

Bonn, , Germany

Countries

Germany

Other Identifiers

AvW-Bonn-01

Identifier Type: -

Identifier Source: org_study_id