e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eSense 7Fr Single Sensor Bladder Catheter.
- Who it may be relevant to
- Registry conditions: Lower Urinary Track Symptoms, Urodynamic Exam. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device eSense 7Fr Single Sensor Bladder Catheter
Urinary and abdominal catheters inserted into the body to measure pressure for urodynamics.
Primary outcome measures
- To determine the range of normal pressure values for different patient positions measured by the e-Sense® catheter [Time frame: Periprocedural, during Urodynamic Procedure]
Secondary outcome measures (1)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Bristol Urological Institute — Bristol
Identifiers
NCT: NCT06905808 · CLN-00085