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

NCT06905808 | Recruiting FDA Device

• 1 other identifier: CLN-00085
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Urodynamic Exam; Lower Urinary Track Symptoms

Keywords

Urodynamic; Lower Urinary Track Symptoms

Outcome Measures

Primary Outcomes (1)

• To determine the range of normal pressure values for different patient positions measured by the e-Sense® catheter

  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.

  Periprocedural, during Urodynamic Procedure

Secondary Outcomes (1)

• To compare pressure values measured by the e-Sense® catheters to the pressures simultaneously measured via a separate water filled catheters.

  Periprocedural, during Urodynamic Procedure

Study Arms (1)

Subjects indicated for UDS study

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.

Device: eSense 7Fr Single Sensor Bladder Catheter

Interventions

eSense 7Fr Single Sensor Bladder Catheter DEVICE

Urinary and abdominal catheters inserted into the body to measure pressure for urodynamics.

Also known as: eSense 7Fr Abdominal Catheters, eSense 7Fr Dual Sensor Urethral Catheters

Subjects indicated for UDS study

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are medically indicated to receive a Urodynamic Procedure in the UK

You may qualify if:

• 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.
• Subjects with range of BMI values
• Subject provides written authorization and/or consent per institution or geographical requirements

You may not qualify if:

• 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

Sponsors & Collaborators

• Laborie Medical Technologies Inc.: lead

Study Sites (1)

Bristol Urological Institute

Bristol, United Kingdom

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 1, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

GB (1)