Air-charged vs Water-filled Catheters (Bonn)

Urodynamics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756182
• Other study ID #: AvW-Bonn-01
• Status: Completed
• Phase: N/A
• Start date: April 27, 2016
• Est. completion date: August 22, 2016

Study information

• Verified date: January 2020
• Source: Laborie Medical Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 22, 2016
• Est. primary completion date: August 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urodynamics

Intervention

Device:
• TDOC air-charged catheter
Urodynamic study utilizing a single catheter technique to measure WP & AC measurements

Locations

Country	Name	City	State
Germany	University Clinic Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
Laborie Medical Technologies Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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