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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urodynamics with AC and WP | Experimental | Patients underwent a conventional urodynamics study utilizing a single catheter technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDOC air-charged catheter | Device | Urodynamic study utilizing a single catheter technique to measure WP & AC measurements |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic Bonn | Bonn | 53177 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Urodynamics With Air-Charged and Water Perfused | Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure Water Perfused (WP) & Air-Charged (AC) measurements |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | cmH2O | Measured during a single urodynamic evaluation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood pressure with autonomic dysreflexia | Blood and lymphatic system disorders | One patient presented an episode of high blood pressure with autonomic dysreflexia, and the infusion pump was therefore stopped at 335 ml before maximum capacity was reached. Adverse event was not related to the device used (catheter). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Laborie | 9056121170 | 1755 | sgallone@laborie.com |
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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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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|
| 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. | Posted | Mean | Standard Deviation | cmH2O | 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. | Posted | Mean | Standard Deviation | cmH2O | 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. | Posted | Mean | Standard Deviation | cmH2O | 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. | Posted | Mean | Standard Deviation | cmH2O | 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. | Posted | Mean | Standard Deviation | cmH2O | Measured during a single urodynamic evaluation |
|
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| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
|
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