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

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

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

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Dysfunction
• Intervention / Treatment: Other: Urodynamic investigation

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Kessler, Prof. Dr.; Phone Number: +41 44 386 39 07; Email: thomas.kessler@balgrist.ch
• Study Contact Backup: Name: Lorenz Leitner, Dr.; Phone Number: +41 44 386 39 07; Email: lorenz.leitner@balgrist.ch

Study Locations

• Switzerland
  • Zürich, Switzerland
    • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urodynamic investigation; Simultaneous UDI (same session repeat filling cystometry and pressure flow study) with an air-charged and water-perfused measurement system.	Other: Urodynamic investigation; Simultaneous UDI (same session repeat filling cystometry and pressure flow study) with an air-charged and water-perfused measurement system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Interchangeability of the measurement method (air-charged vs. water-perfused measurement system) regarding the urodynamic observations, diagnostic result and subsequent treatment	Once during urodynamic investigation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure changes during urodynamics using an air-charged vs. water-perfused measurement system	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]	Once during urodynamic investigation
Changes in bladder compliance [mL/cmH2O] during urodynamics using an air-charged vs. water-perfused measurement system		Once during 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	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	Once during urodynamic investigation and 7 days thereafter

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Lower urinary tract dysfunction; Urodynamic investigation; Water-perfused catheter; Air-charged catheter
• Other Study ID Numbers: UDI-Synchrony 2018-00073

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No