Lower Urinary Track SymptomsESNS-01NCT06905808
e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
An observational study of Lower Urinary Track Symptoms and Urodynamic Exam, run by Laborie Medical Technologies Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lower Urinary Track Symptoms, Urodynamic Exam
- What is being tested?
- eSense 7Fr Single Sensor Bladder Catheter
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are medically indicated to receive a Urodynamic Procedure in the UK
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Bristol Urological Institute
Bristol
Victoria Garner, +0117 414 8109, victoria.garner@nbt.nhs.uk
Andrew Gammie, DPhil CEng CSci
About this study
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).
Read the 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.
- Conditions
- Lower Urinary Track Symptoms, Urodynamic Exam
- Being tested
- eSense 7Fr Single Sensor Bladder Catheter
- Keywords
- Urodynamic, Lower Urinary Track Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSense 7Fr Single Sensor Bladder CatheterDevice
Also called eSense 7Fr Abdominal Catheters, eSense 7Fr Dual Sensor Urethral Catheters
Urinary and abdominal catheters inserted into the body to measure pressure for urodynamics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: eSense 7Fr Single Sensor Bladder Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Periprocedural, during Urodynamic Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start15 Aug 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Track SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laborie Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905808
- Sponsor's protocol ID
- CLN-00085
- Acronym
- ESNS-01
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
- ClinicalTrials.gov ID
- NCT06905808
- Acronym / sponsor ID
- ESNS-01 / CLN-00085
- Conditions
- Lower Urinary Track Symptoms, Urodynamic Exam
- Keywords
- Urodynamic, Lower Urinary Track Symptoms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Laborie Medical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects indicated for UDS study | – | Device: eSense 7Fr Single Sensor Bladder CatheterThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are medically indicated to receive a Urodynamic Procedure in the UK
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eSense 7Fr Single Sensor Bladder CatheterAlso: eSense 7Fr Abdominal Catheters, eSense 7Fr Dual Sensor Urethral CathetersUrinary and abdominal catheters inserted into the body to measure pressure for urodynamics. | Device | Subjects indicated for UDS study |
Primary outcome
To determine the range of normal pressure values for different patient positions measured by the e-Sense® catheter
Time frame: 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.
1 secondary outcome
To compare pressure values measured by the e-Sense® catheters to the pressures simultaneously measured via a separate water filled catheters.
Time frame: Periprocedural, during Urodynamic Procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Track Symptoms and Urodynamic Exam, run by Laborie Medical Technologies Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the range of normal pressure values for different patient positions measured by the e-Sense® catheter (time frame: Periprocedural, during Urodynamic Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.