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Completed

NCT Number: NCT04033770

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

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

Universitätsklinik Balgrist

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 we 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 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

Treatment and study plan

Urodynamic investigation

Other

Urodynamic investigation using an air-charged measurement system

Primary outcomes

  1. Artefact susceptibility of the measurement systems

    Time frame: During the urodynamic investigation

    Number of Artifacts impairing the quality/interpretability of the urodynamic examination

Secondary outcomes

  1. Subjective perception of pain and discomfort (on a visual analog scale) between the measurement systems

    Time frame: During the urodynamic investigation

    Perception of pain and discomfort on a visual analog scale (presented as a 100-mm horizontal line on which the patient's pain and discomfort intensity is represented by a point between the extremes of "no pain/discomfort at all" and "worst pain/discomfort imaginable (from 0 to 10))

  2. 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

    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

  3. Difference in volumetric during urodynamic investigation using an air-charged vs. water-perfused measurement system

    Time frame: During the urodynamic investigation

    Cystometric capacity [mL], volume at first DO [mL], voided volume [mL] and post void residual [mL] as assessed by urodynamic measurement

  4. Difference in Compliance [mL/cmH2O] during urodynamic investigation using an air-charged vs. water-perfused measurement system

    Time frame: During the urodynamic investigation

  5. Difference in Pressure changes during urodynamic investigation using an air-charged vs. water-perfused measurement system

    Time frame: During the 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]

  6. Difference in in maximum flow rate [mL/s] during urodynamic investigation using an air-charged vs. water-perfused measurement system

    Time frame: During the urodynamic investigation

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 - a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2019
Registry last updated
Feb 14, 2022

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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