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

Terminated

• Conditions: Patients Susceptible to Falls

• Registration Number: NCT05183633
• Lead Sponsor: Curbell Medical Products, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-10
• Study Start: 2022-05-10
• Status Verified: 2025-02
• Primary Completion: 2025-02-03
• Study Completion: 2025-02-03
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients that have been previously scheduled for a Urodynamic Study

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Western New York Urology Associates; 🇺🇸 Cheektowaga, New York, United States