e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorLaborie Medical Technologies Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects medically indicated for Urodynamic procedure between ages 20-35 or > 50 years old (equally split male and female)
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
Disqualifiers
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)
Trial population
Subjects who are medically indicated to receive a Urodynamic Procedure in the UK
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
eSense 7Fr Single Sensor Bladder Catheter
DeviceUrinary and abdominal catheters inserted into the body to measure pressure for urodynamics.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Subjects indicated for UDS study1 intervention
Trial outcomes
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.
Time frame
Periprocedural, during Urodynamic ProcedureSecondary 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.
Time frame
Periprocedural, during Urodynamic ProcedureSponsors and contacts
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Source ClinicalTrials.gov