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
1 other identifier
interventional
50
1 country
1
Brief Summary
Comparison of water-perfused (WP) and air-charged (AC) catheters for invasive urodynamic investigation (UDI) regarding consistency, features and artifacts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedApril 13, 2023
April 1, 2023
3.5 years
July 19, 2019
April 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Pressure changes during urodynamics using an air-charged vs. water-perfused measurement system
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
Once during urodynamic investigation and 7 days thereafter
Study Arms (1)
Urodynamic investigation
EXPERIMENTALSimultaneous UDI (same session repeat filling cystometry and pressure flow study) with an air-charged and water-perfused measurement system.
Interventions
Simultaneous UDI (same session repeat filling cystometry and pressure flow study) with an air-charged and water-perfused measurement system.
Eligibility Criteria
You may qualify if:
- Male and female patients
- Age ≥18 years
- Informed consent
- LUTD due to a neurological disorder
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Balgrist University Hospital
Zurich, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2019
First Posted
July 29, 2019
Study Start
October 1, 2019
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
April 13, 2023
Record last verified: 2023-04