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Completed

NCT Number: NCT02756182

Air-charged vs Water-filled Catheters (Bonn)

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.

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Key information

Conditions

Urodynamics

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic Bonn

Bonn, 53177, Germany

About this study

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:

  • 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.
  • 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).
  • To determine if the maximum voiding pressure, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent.
  • To determine if the clinical impressions of the urodynamic study are equivalent for the water-perfused and air-charged catheters.
  • To determine if the compliance of the bladder is equivalent when measured by air-charged catheters as compared to water-perfused catheters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TDOC air-charged catheter

Device

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

Primary outcomes

  1. Maximum Vesical Pressure During Valsalva Manoeuvres

    Time frame: Measured during a single urodynamic evaluation

    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.

  2. Maximum Abdominal Pressure During Valsalva Manoeuvres

    Time frame: Measured during a single urodynamic evaluation

    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.

  3. Maximum Detrusor Pressure at Valsalva Manoeuvres

    Time frame: Measured during a single urodynamic evaluation

    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.

Secondary outcomes

  1. Maximum Vesical Pressure During Coughs

    Time frame: Measured during a single urodynamic evaluation

    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.

  2. Maximum Abdominal Pressure During Coughs

    Time frame: Measured during a single urodynamic evaluation

    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.

  3. Maximum Detrusor Pressure During Coughs

    Time frame: Measured during a single urodynamic evaluation

    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.

Sponsors and collaborators

Lead sponsor

Laborie Medical Technologies Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2016
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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