Comparison of Air-filled and Water-filled Catheters for Use in Cystometric Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Maximum Vesical Pressure During Valsalva Manoeuvres
研究概览
简要总结
A comparative study was conducted and the patient underwent a conventional urodynamic study. In order to successfully determine if the Air-Charged (AC) and Water-Perfused (WP) measurements are equivalent, the two sources of intravesical pressure (Pves) and abdominal pressure (Pabd) were collected concurrently at various fill volumes for the bladder.
详细描述
The objective of this study was to compare the use of water-filled and air-charged catheters in determining equivalency between the two technologies during cystometric assessment.
A total of 25 patients (9M/16F) were recruited. All patients underwent cough and Valsalva manoeuvre pressure tests to measure vesicle pressure (Pves) and abdominal pressure (Pabd). A single dual-lumen catheter (T-DOC 7Fr Air-Charged® catheter) was used to record air and water pressures simultaneously.
The primary outcome was to determine if the maximum pressures during Valsalva manoeuvres, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 200 cc during a urodynamic evaluation.
Exploratory endpoints included the following:
- To determine if maximum pressures for cough, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 100, 200 and Maximum Bladder Capacity (MBC) cc during a urodynamic evaluation.
- To determine if maximum pressures for Valsalva manoeuvres, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 100 and MBC cc during a urodynamic evaluation (as well as 200 cc which is the primary objective).
- To determine if the maximum voiding pressure, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent.
- To determine if the clinical impressions of the urodynamic study are equivalent for the water-perfused and air-charged catheters.
- To determine if the compliance of the bladder is equivalent when measured by air-charged catheters as compared to water-perfused catheters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients normally indicated for urodynamic evaluations
排除标准
- •Patients who suffer from bladder infections (not including patients with asymptomatic bacteruria, prophylaxis with an antibiotic is at the discretion of the physician)
- •Patients who suffer from strictures in the urethra
- •Patients who are pregnant
- •Patients who require the use of a suprapubic catheter
结局指标
主要结局
Maximum Vesical Pressure During Valsalva Manoeuvres
时间窗: Measured during a single urodynamic evaluation
Maximum vesical pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Maximum Abdominal Pressure During Valsalva Manoeuvres
时间窗: Measured during a single urodynamic evaluation
Maximum abdominal pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Maximum Detrusor Pressure at Valsalva Manoeuvres
时间窗: Measured during a single urodynamic evaluation
Maximum detrusor pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
次要结局
- Maximum Vesical Pressure During Coughs(Measured during a single urodynamic evaluation)
- Maximum Abdominal Pressure During Coughs(Measured during a single urodynamic evaluation)
- Maximum Detrusor Pressure During Coughs(Measured during a single urodynamic evaluation)