跳至主要内容
临床试验/NCT05183633
NCT05183633终止不适用

A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures

Curbell Medical Products, Inc.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
40
试验地点
1
主要终点
Correlation of Urge to Urinate to Bioimpedance. Our clinical trial is an attempt to determine the correlation of bioimpedance measurements versus bladder pressure (fullness) taken at the same time during a normally scheduled urodynamic study.

研究概览

简要总结

A Pilot Study to Assess the Association between Human Bioimpedance Measurements and Clinical Urodynamic Procedures

详细描述

The purpose of the study is to assess how well Curbell's Bladder Sensor device measuring bioimpedance correlates to urodynamic studies and the reported sensation subjects feel when reporting bladder fullness and their urge to urinate.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients that have been previously scheduled for a Urodynamic Study

排除标准

  • 未提供

结局指标

主要结局

Correlation of Urge to Urinate to Bioimpedance. Our clinical trial is an attempt to determine the correlation of bioimpedance measurements versus bladder pressure (fullness) taken at the same time during a normally scheduled urodynamic study.

时间窗: Bioimpedance measurements are taken in real time simultaneously with urodynamic pressure measurements. Therefore, the time frame is "zero." Each measurement characterizes actual bioimpedance at that point in time.

Our primary outcome is determining the correlation strength between the bladder's pressure measurements (acquired during a standard urodynamic study) and bioimpedance measurements. That is, we are trying to find if bladder bioimpedance is correlated to bladder fullness, where pressure is the clinically-accepted measurement of bladder fullness in a urodynamic study.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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