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

Assessment of the Lower Urinary Tract: Consistency, Features and Artifacts of Invasive Urodynamic Assessments - a Randomized Controlled Trial

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; 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 we compare both systems regarding consistency, features and artifacts.

• Study Type: Interventional
• Enrollment (Actual): 490
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland
    • Universitätsklinik Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Air-charged measurement system; 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; Urodynamic investigation using an air-charged measurement system; Other: Urodynamic investigation; Urodynamic investigation using a water-perfused measurement system
ACTIVE_COMPARATOR: Water-perfused measurement system; UDI (same session repeat filling cystometry and pressure flow study) according to "Good Urodynamic Practice" recommended by the ICS.	Other: Urodynamic investigation; Urodynamic investigation using an air-charged measurement system; Other: Urodynamic investigation; Urodynamic investigation using a water-perfused measurement system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Artefact susceptibility of the measurement systems	Number of Artifacts impairing the quality/interpretability of the urodynamic examination	During the urodynamic investigation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective perception of pain and discomfort (on a visual analog scale) between the measurement systems	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))	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	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
Difference in volumetric during urodynamic investigation using an air-charged vs. water-perfused measurement system	Cystometric capacity [mL], volume at first DO [mL], voided volume [mL] and post void residual [mL] as assessed by urodynamic measurement	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	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]	During the urodynamic investigation
Difference in in maximum flow rate [mL/s] during urodynamic investigation using an air-charged vs. water-perfused measurement system		During the urodynamic investigation

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ACTUAL): February 11, 2022
• Study Completion (ACTUAL): February 11, 2022

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (ACTUAL): July 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

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-RCT 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