ClinicalTrials.gg
CompletedNCT05694793TRUST-1Updated Oct 1, 2026

Trial for Reliability of Urodynamics SysTem

An interventional study of Glean Urodynamics System and Glean Urodynamics System in Urologic Diseases and Urodynamics, sponsored by Bright Uro. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Bright Uro · Not applicable, Interventional, and Device feasibility

Updated Oct 1, 2026Now CompletedEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Urologic Diseases
  • Urodynamics

Keywords

  • Lower Urinary Tract Dysfunction
  • Urinary Incontinence
  • Overactive Bladder
  • Home Monitoring
  • Urodynamics
  • Uroflowmetry
03

In context

Urologic Diseases

221 studies on the registry are indexed under Urologic Diseases; 48 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 160 interventional studies indexed under Urologic Diseases.

Browse Urologic Diseases studies →

Lead sponsor

Bright Uro is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Female patient must be ≥ 18 years of age
  2. Patient is a candidate for urodynamics per standard of care
  3. Patient or patient's legally authorized representative is able to provide

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. 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).
  3. Patient has history of recurrent UTIs (≥ 3 episodes in previous 12 months).
  4. Patient has used antibiotics within the past 7 days from the baseline/screening visit.
  5. 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).
  6. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).
  7. Patient with a urostomy.
  8. 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).
  9. Patient who has from one or more major strictures in the urethra.
  10. 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).
  11. Patient with a colostomy.
  12. Patient with any abnormal or concerning rectal or vaginal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, active yeast infections, or vaginitis.
  13. Patient has a known inability to void or is in complete retention.
  14. Subjects who, at the principal investigator's determination, would not be appropriate for this study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Glean Urodynamics System

    Device: Glean Urodynamics System

Interventions

  • DeviceGlean Urodynamics System

    Wireless, catheter-free urodynamics system

    Also known as: GUS

  • DeviceGlean Urodynamics System

    Wireless and catheter free urodynamics system

06

What researchers measure

Primary outcomes

  1. Safety

    Proportion of participants experiencing a qualifying adverse event attributable to the investigational device

    Time frame: From date of enrollment to study exit (up to 43 days)

Secondary outcomes

  1. Vesical pressure

    Vesical pressure

    Time frame: during the procedure/surgery

07

Study locations

3 sites
  • Tri Valley Urology Medical Group
    Murrieta, California 92562, United States
  • University of California San Diego
    San Diego, California 92121, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

Publications

  • 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. PubMed 37293725 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 1, 2026
Enrollment
28 (estimated)→30 (actual)
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Active, not recruiting→Completed
    Enrollment 28 (estimated)→30 (actual)
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05694793
Lead sponsor
Bright Uro
Responsible party
Sponsor
First posted
Jan 23, 2023
Start date
Jun 3, 2025
Primary completion
Jul 27, 2026
Completion
Jul 27, 2026
Last update
Oct 1, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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