Trial for Reliability of Urodynamics SysTem
TRUST-1
2 other identifiers
interventional
28
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2023
CompletedFirst Posted
Study publicly available on registry
January 23, 2023
CompletedStudy Start
First participant enrolled
June 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
April 23, 2026
April 1, 2026
1.1 years
January 12, 2023
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Proportion of participants experiencing a qualifying adverse event attributable to the investigational device
From date of enrollment to study exit (up to 43 days)
Secondary Outcomes (1)
Vesical pressure
during the procedure/surgery
Study Arms (1)
Glean Urodynamics System
EXPERIMENTALInterventions
Wireless, catheter-free urodynamics system
Eligibility Criteria
You may qualify if:
- Female patient must be ≥ 18 years of age
- Patient is a candidate for urodynamics per standard of care
- Patient or patient's legally authorized representative is able to provide informed consent
You may not qualify if:
- Pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period
- Patient has one or more symptoms indicative of a urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and/or dysuria).
- Patient has history of recurrent UTIs (≥ 3 episodes in previous 12 months).
- Patient has used antibiotics within the past 7 days from the baseline/screening visit.
- Patient diagnosed with neurogenic LUTS (which may be associated with one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine).
- Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).
- Patient with a urostomy.
- Patient has an atypical anatomic structural variation or has had a previous surgical intervention that has permanently changed structural anatomy anywhere along their lower urinary tract (urethra, pelvic floor, urethral sphincter, and/or bladder wall).
- Patient who has from one or more major strictures in the urethra.
- Patient has a Pelvic Organ Prolapse Quantification (POP-Q) of Grade III or higher (i.e., most distal portion of the prolapse protrudes more than 1 centimeter below the hymen).
- Patient with a colostomy.
- Patient with any abnormal or concerning rectal or vaginal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, active yeast infections, or vaginitis.
- Patient has a known inability to void or is in complete retention.
- Subjects who, at the principal investigator's determination, would not be appropriate for this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Tri Valley Urology Medical Group
Murrieta, California, 92562, United States
University of California San Diego
San Diego, California, 92121, United States
Unio Health Partners
Torrence, California, 90503, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
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.
PMID: 37293725BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2023
First Posted
January 23, 2023
Study Start
June 3, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04