Clinical trial NCT04033770: Urodynamic Assessment of the Lower Urinary Tract: Water vs. Air
Official title: Assessment of the Lower Urinary Tract: Consistency, Features and Artifacts of Invasive Urodynamic Assessments - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Dysfunction
Keywords: Urodynamic investigation
Lower urinary tract dysfunction
Water-perfused catheter
Air-charged catheter
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Artefact susceptibility of the measurement systems
timeFrame: During the urodynamic investigation
Secondary outcomes:
measure: Subjective perception of pain and discomfort (on a visual analog scale) between the measurement systems
timeFrame: During the urodynamic investigation
measure: 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
timeFrame: Once during urodynamic investigation and 7 days thereafter
measure: Difference in volumetric during urodynamic investigation using an air-charged vs. water-perfused measurement system
timeFrame: During the urodynamic investigation
measure: Difference in Compliance [mL/cmH2O] during urodynamic investigation using an air-charged vs. water-perfused measurement system
timeFrame: During the urodynamic investigation
measure: Difference in Pressure changes during urodynamic investigation using an air-charged vs. water-perfused measurement system
timeFrame: During the urodynamic investigation
measure: Difference in in maximum flow rate [mL/s] during urodynamic investigation using an air-charged vs. water-perfused measurement system
timeFrame: During the urodynamic investigation
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsklinik Balgrist
Study officials:
References: