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

Curbell Medical Products, Inc.40 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Patients Susceptible to Falls

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients that have been previously scheduled for a Urodynamic Study Exclusion Criteria: \-

Locations (1)

Western New York Urology Associates

Cheektowaga, New York, United States

Outcomes

Primary Outcomes

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.

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.

Time frame: 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.

Data from ClinicalTrials.gov

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