Study to Define Normal Urodynamic Pressure Values Using e-Sensecatheters in Adults Undergoing Urodynamic Testing

What this Trial Is About

This observational study focuses on subjects referred for urodynamic testing to define normal pressure ranges using the e-Sense4 catheters. Researchers aim to establish typical pressure values in different body positions and during bladder filling to help interpret urodynamic tests. The study is sponsored by Laborie Medical Technologies Inc. and involves adults medically indicated for urodynamic procedures, including those with lower urinary tract symptoms. Participants will undergo urodynamic testing using the e-Sense4 catheters alongside traditional water-filled catheters. Initial resting pressures will be measured in lying, sitting, and standing positions. During bladder filling, various pressure values will be recorded at regular intervals to compare detrusor and urethral pressures between the two catheter types. This single-arm study uses the e-Sense4 device in all participants to collect data for both primary and secondary objectives. Throughout the procedure, urodynamic pressures will be assessed and recorded using the study devices. The results will be provided to the sponsor for test interpretation and publication. Researchers will monitor and compare pressure values simultaneously measured by the e-Sense4 and water-filled catheters during the test. The study participation involves a one-time urodynamic test with no placebo or control group, and the primary outcome is to determine normal pressure ranges by position during the procedure.

e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters