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

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

Detailed Description
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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.

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

Conditions
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Lower Urinary Tract Dysfunction

Intervention / Treatment
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* Other: Urodynamic investigation
* Other: Urodynamic investigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urodynamic investigation, Lower urinary tract dysfunction, Water-perfused catheter, Air-charged catheter