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

Qualifiers

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 design

Treatments tested in this trial

  • eSense 7Fr Single Sensor Bladder Catheter

Treatment groups

40 Participants
are divided into 1 treatment group