Urodynamic Assessment of the Lower Urinary Tract: Water vs. Air

University of Zurich (UZH)

Status: Completed

Conditions: Lower Urinary Tract Dysfunction

Treatments: Other: Urodynamic investigation

Study type: Interventional

Funder types: Other

Identifiers

NCT04033770

UDI-RCT 2018-00073

Details and patient eligibility

About

Comparison of water-perfused (WP) and air-charged (AC) catheters for invasive urodynamic investigation (UDI) regarding consistency, features and artifacts.

Full 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.

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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490 participants in 2 patient groups

Air-charged measurement system

Active Comparator group

Description:

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.

Treatment:

Other: Urodynamic investigation

Other: Urodynamic investigation

Water-perfused measurement system

Active Comparator group

Description:

UDI (same session repeat filling cystometry and pressure flow study) according to "Good Urodynamic Practice" recommended by the ICS.

Treatment:

Other: Urodynamic investigation

Other: Urodynamic investigation