Status:
NOT_YET_RECRUITING
E-Sense® Normal Values of Urodynamic Pressures Using E-Sense® Catheters
Lead Sponsor:
Laborie Medical Technologies Inc.
Conditions:
Lower Urinary Track Symptoms
Urodynamic Exam
Eligibility:
All Genders
20+ years
Brief Summary
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® cathe...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06905808
Start Date
September 1 2025
End Date
December 1 2026
Last Update
April 1 2025
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