Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2023-08-21
2024-04-18
Brief Summary
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The main question\[s\] it aims to answer are:
• What is the feasibility, efficacy, and safety of GUS for use in clinical to collect vesical pressure data in adult males and females with lower urinary tract symptoms?
Participants will undergo a planned conventional urodynamics exam after which the Glean Sensor will be inserted and ambulatory urodynamics will be performed with the sensor indwelling in the bladder after which the sensor will be removed.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Glean Urodynamics System
Wireless, catheter-free urodynamics system
Glean Urodynamics System
Wireless, catheter-free urodynamics system
Interventions
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Glean Urodynamics System
Wireless, catheter-free urodynamics system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must have a diagnosis of LUTD
* Patient must be scheduled for or recommended for cUDS
* Patient is able to tolerate 18Fr catheterization
* Patient or patient's legally authorized representative is able to provide informed consent
Exclusion Criteria
* Patient has a symptomatic UTI based on CDC guidance (see below)
* Subjects who, at the principal investigator's determination, would not be appropriate for this study.
18 Years
ALL
No
Sponsors
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Bright Uro
INDUSTRY
Responsible Party
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Principal Investigators
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Brittany Carter, DHSc, MPH
Role: STUDY_DIRECTOR
Bright Uro
Locations
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Tri Valley Urology
Murrieta, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stony Brook Medicine
East Setauket, New York, United States
Palmetto Adult and Children's Urology
North Charleston, South Carolina, United States
Urology Partners of North Texas
Arlington, Texas, United States
Countries
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References
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Frainey BT, Majerus SJA, Derisavifard S, Lewis KC, Williams AR, Balog BM, Butler RS, Goldman HB, Damaser MS. First in Human Subjects Testing of the UroMonitor: A Catheter-free Wireless Ambulatory Bladder Pressure Monitor. J Urol. 2023 Jul;210(1):186-195. doi: 10.1097/JU.0000000000003451. Epub 2023 Jun 9.
Kim J, Xavier K, Cannon-Smith T, Vaughan T, Vemulapalli S, Zhao H, Aalami-Harandi A, Shah N. The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study. J Endourol. 2025 Jun;39(6):625-634. doi: 10.1089/end.2025.0270. Epub 2025 May 2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CIP-0005
Identifier Type: -
Identifier Source: org_study_id