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

Condition(s) studied

Investigational drug(s) / intervention(s)

eSense 7Fr Single Sensor Bladder Catheter: Urinary and abdominal catheters inserted into the body to measure pressure for urodynamics.

Study summary

In this post-market observational study, subjects referred to urodynamic testing will be approached to enroll in a clinical study to define the normal range of pressure values utilizing e-Sense® catheters. Urodynamic test results using the study devices will be provided back to the study sponsor for test interpretation and to publish. The urodynamic information collected using the study devices will be used in the UDS test interpretation for each subject enrolled, unless there is a reason to believe the test should be repeated (i.e. inconclusive results).

Eligibility

Primary outcome measure(s)

• To determine the range of normal pressure values for different patient positions measured by the e-Sense® catheter — Periprocedural, during Urodynamic Procedure
  The primary endpoint will be measured by recording the subject in three different positions (sitting, lying and standing) to determine a range normal pressures value. The values will be recorded on each subject case report form.

Trial sites (1)