NCT04033770

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

Assessment of the Lower Urinary Tract: Consistency, Features and Artifacts of Invasive Urodynamic Assessments - a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 490 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Urinary Tract Dysfunction

Interventions

Type	Name	Description
OTHER	Urodynamic investigation	Urodynamic investigation using an air-charged measurement system
OTHER	Urodynamic investigation	Urodynamic investigation using a water-perfused measurement system

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-02-11
• Completion: 2022-02-11
• First posted: 2019-07-26
• Last updated: 2022-02-14

Locations

1 site across 1 country: Switzerland