E-Sense® Normal Values of Urodynamic Pressures Using E-Sense® Catheters (ESNS-01)

Laborie Medical Technologies

Status: Not yet enrolling

Conditions: Lower Urinary Track Symptoms; Urodynamic Exam

Treatments: Device: eSense 7Fr Single Sensor Bladder Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT06905808

CLN-00085

Details and patient eligibility

About

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).

Full description

Subjects who are referred to undergo a Urodynamics will be recruited to participate. Initial resting pressures will be measured/recorded using the e-Sense® and water-filled catheter (dual-catheterized) in lying, sitting, and standing positions for each subject. The study will collect various urodynamic pressure values at regular intervals during bladder filling. The detrusor pressures before filling will then be compared with the pressures collected during bladder filling to determine normal pressure value ranges. Urethral pressures will also be measured using e-Sense® and water-filled catheters, and the values compared. The goal is to provide users of the e-Sense® catheter as to what values should be expected when good quality measurements are being made.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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
• Subjects with active untreated bladder infections (not including patients with asymptomatic bacteruria)
• Subjects having greater than 300 mL post void residual on the clinic visit uroflowmetry test

Trial design

40 participants in 1 patient group

Subjects indicated for UDS study

Description:

The e-Sense® catheters will be used in all subjects to assess primary and secondary objectives. It is a single arm study with no comparative, placebo, sham or control arm.

Treatment:

Device: eSense 7Fr Single Sensor Bladder Catheter