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Comparison of water-perfused (WP) and air-charged (AC) catheters for invasive urodynamic investigation (UDI) regarding consistency, features and artifacts.
UDI is the gold standard to assess refractory lower urinary tract symptoms (LUTS), i.e. to detect and specify lower urinary tract dysfunction (LUTD). Therefore, UDI findings lead to diagnosis and decision-making for further non-invasive and invasive therapies. For UDI pressure recordings, the use of WP catheters is recommended by the International Continence Society (ICS).
Currently AC catheters have been marked for pressure recording as an alternative to WP catheters. However, the number of comparative studies is very limited. Nevertheless, since release, AC catheters have gained popularity due to their omnidirectional detection of pressure, and claimed reduction in movement artefacts (due to weight-less air column vs weighted water column), lack of external reference level, and ease of set-up/use. Still, there is debate whether AC catheters are an acceptable alternative to fluid-filled lines for measuring intravesical and intra-abdominal pressure in UDI. Based on the available literature, an appropriate conclusion, whether both systems can be used as equivalents and interchangeably, cannot be drawn.
In this study we compare both systems regarding consistency, features and artifacts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air-charged measurement system | Active Comparator | UDI (same session repeat filling cystometry and pressure flow study) according to "Good Urodynamic Practice" recommended by the ICS but using an air-charged instead of a water-filled measurement system. |
|
| Water-perfused measurement system | Active Comparator | UDI (same session repeat filling cystometry and pressure flow study) according to "Good Urodynamic Practice" recommended by the ICS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urodynamic investigation | Other | Urodynamic investigation using an air-charged measurement system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Artefact susceptibility of the measurement systems | Number of Artifacts impairing the quality/interpretability of the urodynamic examination | During the urodynamic investigation |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective perception of pain and discomfort (on a visual analog scale) between the measurement systems | Perception of pain and discomfort on a visual analog scale (presented as a 100-mm horizontal line on which the patient's pain and discomfort intensity is represented by a point between the extremes of "no pain/discomfort at all" and "worst pain/discomfort imaginable (from 0 to 10)) | During the urodynamic investigation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik Balgrist | Zurich | Switzerland |
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| Urodynamic investigation | Other | Urodynamic investigation using a water-perfused measurement system |
|
| Incidence of side effects: number and intensity/severity (mild/moderate/severe) of AEs and SAE for the following categories during and for 7 days after the urodynamic investigation using an air-charged vs. water-perfused measurement system | Infection - Urinary Tract Infection (UTI); severe or sudden increase in pain; severe or sudden increase in spasticity; autonomic dysreflexia; urgent (unexpected) transfer/admittance to an acute care facility | Once during urodynamic investigation and 7 days thereafter |
| Difference in volumetric during urodynamic investigation using an air-charged vs. water-perfused measurement system | Cystometric capacity [mL], volume at first DO [mL], voided volume [mL] and post void residual [mL] as assessed by urodynamic measurement | During the urodynamic investigation |
| Difference in Compliance [mL/cmH2O] during urodynamic investigation using an air-charged vs. water-perfused measurement system | During the urodynamic investigation |
| Difference in Pressure changes during urodynamic investigation using an air-charged vs. water-perfused measurement system | Maximum DO amplitude [cmH2O], detrusor leak-point pressure [cmH2O], maximum detrusor pressure [cmH2O] during storage phase, maximum detrusor pressure [cmH2O] during voiding phase, detrusor pressure at maximum flow rate [cmH2O] | During the urodynamic investigation |
| Difference in in maximum flow rate [mL/s] during urodynamic investigation using an air-charged vs. water-perfused measurement system | During the urodynamic investigation |