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

NCT04033770 | Completed

• 1 other identifier: UDI-RCT 2018-00073
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lower Urinary Tract Dysfunction

Keywords

Urodynamic investigation; Lower urinary tract dysfunction; Water-perfused catheter; Air-charged catheter

Outcome Measures

Primary Outcomes (1)

• Artefact susceptibility of the measurement systems

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

  During the urodynamic investigation

Secondary Outcomes (6)

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

  During the urodynamic investigation

• 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

  Once during urodynamic investigation and 7 days thereafter

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

  During the urodynamic investigation

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

  During the urodynamic investigation

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

  During the urodynamic investigation

Study Arms (2)

Air-charged measurement system

ACTIVE COMPARATOR

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.

Other: Urodynamic investigation

Water-perfused measurement system

ACTIVE COMPARATOR

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

Other: Urodynamic investigation

Interventions

Urodynamic investigation OTHER

Urodynamic investigation using an air-charged measurement system

Air-charged measurement system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with LUTD
• Age: minimum 18 years
• Informed consent
• Competent German language skills

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Universitätsklinik Balgrist

Zurich, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: July 26, 2019
• Study Start: February 1, 2021
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

CH (1)