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

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).

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Track Symptoms; Urodynamic Exam
• Intervention / Treatment: Device: eSense 7Fr Single Sensor Bladder Catheter

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom
    • Recruiting
    • Bristol Urological Institute
    • Contact: Victoria Garner; Phone Number: +0117 414 8109; Email: victoria.garner@nbt.nhs.uk
    • Principal Investigator: Andrew Gammie, DPhil CEng CSci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Urinary and abdominal catheters inserted into the body to measure pressure for urodynamics.; Other Names: eSense 7Fr Abdominal Catheters, eSense 7Fr Dual Sensor Urethral Catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare pressure values measured by the e-Sense® catheters to the pressures simultaneously measured via a separate water filled catheters.	To investigate the change of pressures readings when the subject changes positions, a comparison would be made in the change of pressure recorded by both e-Sense® and water filled catheters when the subject moves from supine to sitting and from sitting to standing.	Periprocedural, during Urodynamic Procedure

Collaborators and Investigators

• Sponsor: Laborie Medical Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Urodynamic; Lower Urinary Track Symptoms
• Other Study ID Numbers: CLN-00085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No