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

Launched by LABORIE MEDICAL TECHNOLOGIES INC. · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the normal pressure values in the bladder and urinary system using special devices called e-Sense® catheters during urodynamic testing. Urodynamic testing helps doctors understand how well the bladder and urethra are working, especially for people experiencing lower urinary tract symptoms. The goal of this study is to gather data that can help establish a standard range of pressure values that can be considered normal.

To participate in this study, individuals must be between the ages of 20-35 or over 50 years old and meet specific health criteria. For example, women aged 20-35 should not have had children, while those over 50 should have had at least one vaginal birth. Participants will undergo the urodynamic test using the e-Sense® catheters, and their results will be shared with the study team for analysis. It’s important to note that certain individuals, such as those with cognitive conditions or active bladder infections, will not be eligible to join the study. Overall, this trial aims to provide valuable information that could enhance our understanding of bladder function and improve care for individuals with urinary symptoms.

Gender

ALL

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