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

NCT ID: NCT04036123

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2023-03-31

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, the investigators compare both systems regarding consistency, features and artifacts.

Conditions

Lower Urinary Tract Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Urodynamic investigation

Simultaneous UDI (same session repeat filling cystometry and pressure flow study) with an air-charged and water-perfused measurement system.

Group Type: EXPERIMENTAL

Urodynamic investigation

Intervention Type: OTHER

Simultaneous UDI (same session repeat filling cystometry and pressure flow study) with an air-charged and water-perfused measurement system.

Interventions

Urodynamic investigation

Simultaneous UDI (same session repeat filling cystometry and pressure flow study) with an air-charged and water-perfused measurement system.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male and female patients
• Age ≥18 years
• Informed consent
• LUTD due to a neurological disorder
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Balgrist University Hospital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

UDI-Synchrony 2018-00073

Identifier Type: -

Identifier Source: org_study_id