Urologic DiseasesTRUST-1NCT05694793
Trial for Reliability of Urodynamics SysTem
A study testing Glean Urodynamics System in people with Urologic Diseases and Urodynamics, run by Bright Uro at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urologic Diseases, Urodynamics
- What is being tested?
- Glean Urodynamics System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jun 2025to 27 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Tri Valley Urology Medical Group
Murrieta, California, 92562
University of California San Diego
San Diego, California, 92121
About this study
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.
- Conditions
- Urologic Diseases, Urodynamics
- Being tested
- Glean Urodynamics System
- Keywords
- Lower Urinary Tract Dysfunction, Urinary Incontinence, Overactive Bladder, Home Monitoring, Urodynamics, Uroflowmetry
- Medical subject headings
- Urologic Diseases, Urinary Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glean Urodynamics SystemDevice
Also called GUS
Wireless, catheter-free urodynamics system
Glean Urodynamics SystemDevice
Wireless and catheter free urodynamics system
| Study group | Role | What they receive |
|---|---|---|
| Glean Urodynamics System | Experimental | Not described Receives: Device: Glean Urodynamics System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Proportion of participants experiencing a qualifying adverse event attributable to the investigational device
Measured: From date of enrollment to study exit (up to 43 days)
Secondary outcomes (1)
Vesical pressure
Vesical pressure
Measured: during the procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start3 Jun 2025
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bright Uro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694793
- Sponsor's protocol ID
- CIP-0006
- Other IDs
- 1R44DK131700
- Acronym
- TRUST-1
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial for Reliability of Urodynamics SysTem
- ClinicalTrials.gov ID
- NCT05694793
- Acronym / sponsor ID
- TRUST-1 / CIP-0006
- Conditions
- Urologic Diseases, Urodynamics
- Keywords
- Lower Urinary Tract Dysfunction, Urinary Incontinence, Overactive Bladder, Home Monitoring, Urodynamics, Uroflowmetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bright UroIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glean Urodynamics System | Experimental | Device: Glean Urodynamics System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glean Urodynamics SystemAlso: GUSWireless, catheter-free urodynamics system | Device | Glean Urodynamics System |
| Glean Urodynamics SystemWireless and catheter free urodynamics system | Device | Glean Urodynamics System |
Primary outcome
Safety
Time frame: From date of enrollment to study exit (up to 43 days)
Proportion of participants experiencing a qualifying adverse event attributable to the investigational device
1 secondary outcome
Vesical pressure
Time frame: during the procedure/surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 37293725Frainey 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glean Urodynamics System in people with Urologic Diseases and Urodynamics, run by Bright Uro at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: From date of enrollment to study exit (up to 43 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05694793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.