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

Lower Urinary Tract Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033770
• Other study ID #: UDI-RCT 2018-00073
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: February 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Dysfunction

Intervention

Other:
• Urodynamic investigation
Urodynamic investigation using an air-charged measurement system
• Urodynamic investigation
Urodynamic investigation using a water-perfused measurement system

Locations

Country	Name	City	State
Switzerland	Universitätsklinik Balgrist	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Artefact susceptibility of the measurement systems	Number of Artifacts impairing the quality/interpretability of the urodynamic examination	During the urodynamic investigation
Secondary	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
Secondary	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
Secondary	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
Secondary	Difference in Compliance [mL/cmH2O] during urodynamic investigation using an air-charged vs. water-perfused measurement system		During the urodynamic investigation
Secondary	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
Secondary	Difference in in maximum flow rate [mL/s] during urodynamic investigation using an air-charged vs. water-perfused measurement system		During the urodynamic investigation