Air-charged vs Water-filled Catheters (Bonn)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02756182

Enrollment

Registered

2016-04-29

Start date

2016-04-27

Completion date

2016-08-22

Last updated

2020-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urodynamics

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.

Interventions

DEVICETDOC air-charged catheter

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Maximum Vesical Pressure During Valsalva Manoeuvres	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.
Maximum Abdominal Pressure During Valsalva Manoeuvres	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.
Maximum Detrusor Pressure at Valsalva Manoeuvres	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

Measure	Time frame	Description
Maximum Vesical Pressure During Coughs	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.
Maximum Abdominal Pressure During Coughs	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.
Maximum Detrusor Pressure During Coughs	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.

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Urodynamics With AC and WP Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WP & AC measurements	25
Total	25

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	StudyTechnical Difficulties	4

Baseline characteristics

Characteristic	Urodynamics With AC and WP
Age, Continuous	43.3 years
Region of Enrollment Germany	25 Participants
Sex: Female, Male Female	16 Participants
Sex: Female, Male Male	9 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 25
other Total, other adverse events	1 / 25
serious Total, serious adverse events	0 / 25

Outcome results

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.