e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters

Laborie Medical Technologies Inc.40 enrolled

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).

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 Type

OBSERVATIONAL

Enrollment

Conditions

Lower Urinary Track Symptoms Urodynamic Exam

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Procedure

Secondary Outcomes

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.