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In this post-market observational study, subjects referred to urodynamic testing will be approached to enroll in a clinical study to define the normal range of pressure values utilizing e-Sense® catheters. Urodynamic test results using the study devices will be provided back to the study sponsor for test interpretation and to publish. The urodynamic information collected using the study devices will be used in the UDS test interpretation for each subject enrolled, unless there is a reason to believe the test should be repeated (i.e. inconclusive results).
Subjects who are referred to undergo a Urodynamics will be recruited to participate. Initial resting pressures will be measured/recorded using the e-Sense® and water-filled catheter (dual-catheterized) in lying, sitting, and standing positions for each subject. The study will collect various urodynamic pressure values at regular intervals during bladder filling. The detrusor pressures before filling will then be compared with the pressures collected during bladder filling to determine normal pressure value ranges. Urethral pressures will also be measured using e-Sense® and water-filled catheters, and the values compared. The goal is to provide users of the e-Sense® catheter as to what values should be expected when good quality measurements are being made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects indicated for UDS study | The e-Sense® catheters will be used in all subjects to assess primary and secondary objectives. It is a single arm study with no comparative, placebo, sham or control arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eSense 7Fr Single Sensor Bladder Catheter | Device | Urinary and abdominal catheters inserted into the body to measure pressure for urodynamics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the range of normal pressure values for different patient positions measured by the e-Sense® catheter | The primary endpoint will be measured by recording the subject in three different positions (sitting, lying and standing) to determine a range normal pressures value. The values will be recorded on each subject case report form. | Periprocedural, during Urodynamic Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| To compare pressure values measured by the e-Sense® catheters to the pressures simultaneously measured via a separate water filled catheters. | To investigate the change of pressures readings when the subject changes positions, a comparison would be made in the change of pressure recorded by both e-Sense® and water filled catheters when the subject moves from supine to sitting and from sitting to standing. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who are medically indicated to receive a Urodynamic Procedure in the UK
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Urological Institute | Recruiting | Bristol | United Kingdom |
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| Periprocedural, during Urodynamic Procedure |