Actively Recruiting
e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
Led by Laborie Medical Technologies Inc. · Updated on 2026-04-29
40
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects medically indicated for Urodynamic procedure between ages 20-35 or older than 50 years old (equally split male and female)
- Female subjects 20-35 years old should be nulliparous (never given birth)
- Female subjects older than 50 years should have given birth vaginally at least once
- Subjects with a range of BMI values
- Subjects must provide written consent according to institutional or geographical requirements
You will not qualify if you...
- Subjects with cognitive or psychiatric conditions that interfere with accurate communication or informed consent
- Subjects with any anal or rectal symptoms or history of surgery
- Pregnant women
- Subjects with active untreated bladder infections (excluding asymptomatic bacteriuria)
- Subjects with post void residual urine greater than 300 mL on clinic uroflowmetry test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bristol Urological Institute
Bristol, United Kingdom
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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