An interventional study of Glean Urodynamics System in Urologic Diseases and Urodynamics, sponsored by Bright Uro. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Bright Uro · Not applicable, Interventional, and Device feasibility
The goal of this prospective trial is to evaluate the feasibility, efficacy, and safety of the Glean Urodynamics System (GUS) for use in the clinic to collect vesical pressure data in adult males and females with lower urinary tract symptoms.
The main question[s] it aims to answer are:
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.
221 studies on the registry are indexed under Urologic Diseases; 48 are open to participants now.
This study's enrollment of 38 is below the median of 80 across 160 interventional studies indexed under Urologic Diseases.
Browse Urologic Diseases studies →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.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Wireless, catheter-free urodynamics system
Device: Glean Urodynamics System
Wireless, catheter-free urodynamics system
Also known as: GUS
Percentage of Participants With Insertion Success
Percent of insertion attempts of the Glean sensor deemed successful
Time frame: during the insertion procedure of a device
Percentage of Participants With a Device-related SAE
Device-related serious adverse events
Time frame: up to 2 weeks
Percentage of Participants With Removal Success
Percent of removal attempts of the Glean sensor deemed successful
Time frame: during the removal procedure of a device
Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable
Number of participants rating the overall comfort of Glean Urodynamics at comfortable or extremely comfortable
Time frame: asked at end of Glean Urodynamics procedure
| Milestone | Glean Urodynamics System |
|---|---|
| Started | 38 |
| Underwent conventional uds | 34 |
| Underwent glean urodynamics | 32 |
| Completed | 28 |
| Not completed | 10 |
Percent of insertion attempts of the Glean sensor deemed successful
| Participants | Glean Urodynamics System |
|---|---|
| Percentage of Participants With Insertion Success | 32 |
Device-related serious adverse events
| Participants | Glean Urodynamics System |
|---|---|
| Percentage of Participants With a Device-related SAE | 0 |
Number of participants rating the overall comfort of Glean Urodynamics at comfortable or extremely comfortable
| Participants | Glean Urodynamics System |
|---|---|
| Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable | 13 |
Percent of removal attempts of the Glean sensor deemed successful
| Participants | Glean Urodynamics System |
|---|---|
| Percentage of Participants With Removal Success | 32 |
Collected over From enrollment until end of follow-up, up to 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/38 (0%) | 0/38 (0%) | 12/38 (31.6%) |
| Glean Urodynamics System | 0/32 (0%) | 0/32 (0%) | 7/32 (21.9%) |
| Event | All Participants | Glean Urodynamics System |
|---|---|---|
| Gross HematuriaRenal and urinary disorders | 9/38 | 4/32 |
| Genitourinary pain or discomfortRenal and urinary disorders | 2/38 | 2/32 |
| DysuriaRenal and urinary disorders | 2/38 | 1/32 |
Participants enrolled in the study
| Age, Customized(Years) | Glean Urodynamics System |
|---|---|
| Age | 64 (25 to 87) |
| Sex: Female, Male(Participants) | Glean Urodynamics System |
|---|---|
| Female | 17 |
| Male | 21 |
| Race (NIH/OMB)(Participants) | Glean Urodynamics System |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 32 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Glean Urodynamics System |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 35 |
| Unknown or Not Reported | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2023 to primary completion in Apr 2024, 7 months.
Results were first posted in Dec 2025, 1 year 8 months after primary completion.
Of 57 interventional studies with no phase under Urologic Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Bright Uro