An interventional study of Glean Urodynamics System in Lower Urinary Tract Symptoms (LUTS), sponsored by Bright Uro. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Bright Uro · Not applicable, Interventional, and Other
A prospective, open-label, single arm interventional trial to establish normative reference ranges for urodynamics parameters in healthy adult participants using using the Glean Urodynamics System.
Subjects will have the Glean Urodynamics System inserted for an in-clinic ambulatory monitoring period. Afterward, they will be discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, not exceeding 24 hours. The sensor will be removed within 24 hours of insertion. Subjects will receive a follow-up phone call 7 days post-removal.
416 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's planned enrollment of 72 is below the median of 100 across 272 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →Bright Uro is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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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.
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.
Device: Glean Urodynamics System
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.
Range of vesical pressure (Pves)
Range of vesical pressure (Pves) in cm H2O as measured by the Glean Bladder Sensor
Time frame: Periprocedurally
Not enrolling at this site.
Plan to share: No — Proprietary data
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 ↗
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Lower Urinary Tract Symptoms →
Bright Uro