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No-Catheter bladder test shows promise in small study

NCT ID NCT05959655

Diagnosis Sponsor: Bright Uro Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new wireless device called the Glean Urodynamics System (GUS) that measures bladder pressure without a catheter. Thirty-eight adults with urinary symptoms used the device after a standard test. The goal was to see if the device is safe, easy to use, and more comfortable than the traditional method.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Glean Urodynamics System (GUS) - a wireless, catheter-free device
What this could lead to
If successful, this device could offer a more comfortable way to diagnose bladder problems, replacing the standard catheter-based test.
What could go wrong
This was a small, early feasibility study with only 38 participants, so results may not apply to everyone. The device may not work as well as the standard test.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

38 people

The number who actually took part.

Started

Aug 2023

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patient must be ≥ 18 years of age * Patient must have a diagnosis of LUTD * Patient must be scheduled for or recommended for cUDS * Patient is able to tolerate 18Fr catheterization * Patient or patient's legally authorized representative is able to provide informed consent Exclusion Criteria: * Pregnant (as confirmed by urine pregnancy test) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period. * Patient has a symptomatic UTI based on CDC guidance (see below) * Subjects who, at the principal investigator's determination, would not be appropriate for this study.

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Conditions

The condition(s) this trial relates to.

overactive bladder Urinary Incontinence urinary system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urodynamics Urologic diseases

Contacts and locations

Locations

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Palmetto Adult and Children's Urology

    North Charleston, South Carolina, 29406, United States

  • Stony Brook Medicine

    East Setauket, New York, 11733, United States

  • Tri Valley Urology

    Murrieta, California, 92562, United States

  • Urology Partners of North Texas

    Arlington, Texas, 76017, United States

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