Lower Urinary Tract Dysfunction
Conditions
Keywords
Urodynamic investigation, Lower urinary tract dysfunction, Water-perfused catheter, Air-charged catheter
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.
Interventions
Urodynamic investigation using an air-charged measurement system
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients with LUTD * Age: minimum 18 years * Informed consent * Competent German language skills
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Artefact susceptibility of the measurement systems | During the urodynamic investigation | Number of Artifacts impairing the quality/interpretability of the urodynamic examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 \[cmH2O\] |
| Difference in in maximum flow rate [mL/s] during urodynamic investigation using an air-charged vs. water-perfused measurement system | 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 | — |
Countries
Switzerland
Outcome results
None listed