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Completed

NCT Number: NCT04036123

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balgrist University Hospital

Zurich, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urodynamic investigation

Other

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

Primary outcomes

  1. Interchangeability of the measurement method (air-charged vs. water-perfused measurement system) regarding the urodynamic observations, diagnostic result and subsequent treatment

    Time frame: Once during urodynamic investigation

Secondary outcomes

  1. Pressure changes during urodynamics using an air-charged vs. water-perfused measurement system

    Time frame: Once during 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]

  2. Changes in bladder compliance [mL/cmH2O] during urodynamics using an air-charged vs. water-perfused measurement system

    Time frame: Once during urodynamic investigation]

  3. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Assessment of the Lower Urinary Tract: Consistency, Features and Artifacts of Invasive Urodynamic Assessments - Synchrony

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2019
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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