Patients Susceptible to Falls
Conditions
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.
Interventions
None listed
Sponsors
Curbell Medical Products, Inc.
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients that have been previously scheduled for a Urodynamic Study
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed