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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
490
Urodynamic investigation using an air-charged measurement system
Urodynamic investigation using a water-perfused measurement system
Universitätsklinik Balgrist
Zurich, Switzerland
Artefact susceptibility of the measurement systems
Number of Artifacts impairing the quality/interpretability of the urodynamic examination
Time frame: During the urodynamic investigation
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))
Time frame: During the urodynamic investigation
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
Time frame: 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
Time frame: During the urodynamic investigation
Difference in Compliance [mL/cmH2O] during urodynamic investigation using an air-charged vs. water-perfused measurement system
Time frame: During the urodynamic investigation
Difference in Pressure changes during urodynamic investigation using an air-charged vs. water-perfused measurement system
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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 \[cmH2O\]
Time frame: During the urodynamic investigation
Difference in in maximum flow rate [mL/s] during urodynamic investigation using an air-charged vs. water-perfused measurement system
Time frame: During the urodynamic investigation