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Trial for Reliability of Urodynamics SysTem
Sponsor: Bright Uro
Summary
The goal of this prospective trial is to assess the safety and reliability of the Glean Urodynamics System (GUS) in adult females with lower urinary tract symptoms. The main question\[s\] it aims to answer are: • What is GUS's ability to safely and reliably conduct wireless, catheter-free monitoring of vesical pressure compared to the vesical pressures collected with conventional urodynamics? Participants will undergo a conventional urodynamics exam, a simultaneous urodynamics exam with GUS, ambulatory urodynamics with GUS, and extended home monitoring with GUS. Researchers will compare GUS data with that from a conventional urodynamics exam.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2025-06-03
Completion Date
2026-07
Last Updated
2025-09-19
Healthy Volunteers
No
Conditions
Interventions
Glean Urodynamics System
Wireless, catheter-free urodynamics system
Glean Urodynamics System
Wireless and catheter free urodynamics system
Locations (4)
Tri Valley Urology Medical Group
Murrieta, California, United States
University of California San Diego
San Diego, California, United States
Unio Health Partners
Torrence, California, United States
Cleveland Clinic
Cleveland, Ohio, United States