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RECRUITING
NCT05694793
NA

Trial for Reliability of Urodynamics SysTem

Sponsor: Bright Uro

View on ClinicalTrials.gov

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

Interventions

DEVICE

Glean Urodynamics System

Wireless, catheter-free urodynamics system

DEVICE

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