E-Sense® Normal Values of Urodynamic Pressures Using E-Sense® Catheters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- To determine the range of normal pressure values for different patient positions measured by the e-Sense® catheter
研究概览
简要总结
In this post-market observational study, subjects referred to urodynamic testing will be approached to enroll in a clinical study to define the normal range of pressure values utilizing e-Sense® catheters. Urodynamic test results using the study devices will be provided back to the study sponsor for test interpretation and to publish. The urodynamic information collected using the study devices will be used in the UDS test interpretation for each subject enrolled, unless there is a reason to believe the test should be repeated (i.e. inconclusive results).
详细描述
Subjects who are referred to undergo a Urodynamics will be recruited to participate. Initial resting pressures will be measured/recorded using the e-Sense® and water-filled catheter (dual-catheterized) in lying, sitting, and standing positions for each subject. The study will collect various urodynamic pressure values at regular intervals during bladder filling. The detrusor pressures before filling will then be compared with the pressures collected during bladder filling to determine normal pressure value ranges. Urethral pressures will also be measured using e-Sense® and water-filled catheters, and the values compared. The goal is to provide users of the e-Sense® catheter as to what values should be expected when good quality measurements are being made.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects medically indicated for Urodynamic procedure between ages 20-35 or > 50 years old (equally split male and female)
- •Due to aging and giving birth significantly affecting the urethra:
- •Female subjects 20-35 should be nulliparous.
- •Female subjects > 50 years old should have given birth to at least one child vaginally. Further caesarian births would not mean exclusion from the study.
- •Subjects with range of BMI values
- •Subject provides written authorization and/or consent per institution or geographical requirements
排除标准
- •Subjects with cognitive or psychiatric conditions that interfere with or precludes direct and accurate communication regarding the study, giving informed consent
- •Any anal / rectal symptoms and/or surgery
- •Pregnant women
- •Subjects with active untreated bladder infections (not including patients with asymptomatic bacteruria)
- •Subjects having greater than 300 mL post void residual on the clinic visit uroflowmetry test
结局指标
主要结局
To determine the range of normal pressure values for different patient positions measured by the e-Sense® catheter
时间窗: Periprocedural, during Urodynamic Procedure
The primary endpoint will be measured by recording the subject in three different positions (sitting, lying and standing) to determine a range normal pressures value. The values will be recorded on each subject case report form.
次要结局
- To compare pressure values measured by the e-Sense® catheters to the pressures simultaneously measured via a separate water filled catheters.(Periprocedural, during Urodynamic Procedure)