e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
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
| Condition(s) | Lower Urinary Track Symptoms, Urodynamic Exam |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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). |
| Who can participate | Inclusion Criteria: * Subjects medically indicated for Urodynamic procedure between ages 20-35 or \> 50 years old (equally split male and female) * Due to aging and giving birth significantly affecting the urethra: * Female subjects 20-35 should be nulliparous. * Female subjects \> 50 years old should have given birth to at least one child vaginally. Further caesarian births would not mean exclusion from the study. * Subjects with range of BMI values * Subject provides written authorization and/or consent per institution or geographical requirements Exclusion Criteria: * Subjects with cognitive or psychiatric conditions that interfere with or precludes direct and accurate communication regarding the study, giving informed consent * Any anal / rectal symptoms and/or surgery * Pregnant women |
| Ages | 20 Years |
| Sex | All |
| Lead sponsor | Laborie Medical Technologies Inc. |
| Locations | Bristol, United Kingdom |
| Start date | 2025-08-15 |
| NCT ID | NCT06905808 |
| Official listing | https://clinicaltrials.gov/study/NCT06905808 |