Air-charged vs Water-filled Catheters (Bonn)

Comparison of Air-filled and Water-filled Catheters for Use in Cystometric Assessment

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.

Study Overview

• Status: Completed
• Conditions: Urodynamics
• Intervention / Treatment: Device: TDOC air-charged catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53177
    • University Clinic Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urodynamics with AC and WP; Patients underwent a conventional urodynamics study utilizing a single catheter technique	Device: TDOC air-charged catheter; Urodynamic study utilizing a single catheter technique to measure WP & AC measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Vesical Pressure During Valsalva Manoeuvres	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.	Measured during a single urodynamic evaluation
Maximum Abdominal Pressure During Valsalva Manoeuvres	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.	Measured during a single urodynamic evaluation
Maximum Detrusor Pressure at Valsalva Manoeuvres	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.	Measured during a single urodynamic evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Vesical Pressure During Coughs	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.	Measured during a single urodynamic evaluation
Maximum Abdominal Pressure During Coughs	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.	Measured during a single urodynamic evaluation
Maximum Detrusor Pressure During Coughs	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.	Measured during a single urodynamic evaluation

Collaborators and Investigators

• Sponsor: Laborie Medical Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2016
• Primary Completion (Actual): August 22, 2016
• Study Completion (Actual): August 22, 2016

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AvW-Bonn-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No