Urodynamic Assessment of the Lower Urinary Tract: Water vs. Air
- Conditions
- Lower Urinary Tract Dysfunction
- Interventions
- Other: Urodynamic investigation
- Registration Number
- NCT04033770
- Lead Sponsor
- University of Zurich
- Brief Summary
Comparison of water-perfused (WP) and air-charged (AC) catheters for invasive urodynamic investigation (UDI) regarding consistency, features and artifacts.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 490
- Male and female patients with LUTD
- Age: minimum 18 years
- Informed consent
- Competent German language skills
- Age <18 years
- Pregnancy or breast feeding (see chapter 3.6.)
- Symptomatic UTI
- Individuals especially in need of protection
- No informed consent
- Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on.
- Earlier participation in this clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Water-perfused measurement system Urodynamic investigation UDI (same session repeat filling cystometry and pressure flow study) according to "Good Urodynamic Practice" recommended by the ICS. Air-charged measurement system Urodynamic investigation 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.
- Primary Outcome Measures
Name Time Method Artefact susceptibility of the measurement systems During the urodynamic investigation Number of Artifacts impairing the quality/interpretability of the urodynamic examination
- Secondary Outcome Measures
Name Time Method Difference in in maximum flow rate [mL/s] during urodynamic investigation using an air-charged vs. water-perfused measurement system During the urodynamic investigation Subjective perception of pain and discomfort (on a visual analog scale) between the measurement systems During the urodynamic investigation 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))
Difference in volumetric during urodynamic investigation using an air-charged vs. water-perfused measurement system During the urodynamic investigation Cystometric capacity \[mL\], volume at first DO \[mL\], voided volume \[mL\] and post void residual \[mL\] as assessed by urodynamic measurement
Difference in Compliance [mL/cmH2O] during urodynamic investigation using an air-charged vs. water-perfused measurement system 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 Once during urodynamic investigation and 7 days thereafter 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
Difference in Pressure changes during urodynamic investigation using an air-charged vs. water-perfused measurement system During the urodynamic investigation 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 \[cmH2O\]
Trial Locations
- Locations (1)
Universitätsklinik Balgrist
🇨🇭Zürich, Switzerland