Assessment of the Lower Urinary Tract: Consistency, Features and Artifacts of Invasive Urodynamic Assessments - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- Artefact susceptibility of the measurement systems
研究概览
简要总结
Comparison of water-perfused (WP) and air-charged (AC) catheters for invasive urodynamic investigation (UDI) regarding consistency, features and artifacts.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with LUTD
- •Age: minimum 18 years
- •Informed consent
- •Competent German language skills
排除标准
- •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
结局指标
主要结局
Artefact susceptibility of the measurement systems
时间窗: During the urodynamic investigation
Number of Artifacts impairing the quality/interpretability of the urodynamic examination
次要结局
- Difference in in maximum flow rate [mL/s] during urodynamic investigation using an air-charged vs. water-perfused measurement system(During the urodynamic investigation)
- Subjective perception of pain and discomfort (on a visual analog scale) between the measurement systems(During the urodynamic investigation)
- Difference in volumetric during urodynamic investigation using an air-charged vs. water-perfused measurement system(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)
- 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(Once during urodynamic investigation and 7 days thereafter)
- Difference in Pressure changes during urodynamic investigation using an air-charged vs. water-perfused measurement system(During the urodynamic investigation)