Bladder monitor could replace awkward clinic tests
NCT ID NCT07425015
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new device called the Glean Urodynamics System, which uses sensors and an app to monitor bladder function both in the clinic and at home. It includes 101 adults with bladder issues like overactive bladder or incontinence. The goal is to see if the device is safe and works well for diagnosing these conditions.
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 (a device with sensors and an app)
- What this could lead to
- If successful, this could offer a more comfortable and convenient way to diagnose bladder problems, potentially reducing the need for repeat clinic visits.
- What could go wrong
- This is an early-stage trial with only 101 participants, so results may not apply to everyone. The device may cause discomfort or fail to provide clear data.
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
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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
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About 101 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Male or female patient must be ≥ 22 years of age. 2. Patient is a candidate for UDS per standard of care. 3. Patient is able to provide informed consent. Exclusion Criteria: 1. 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). 2. Patient has a history of recurrent UTIs (≥ 3 episodes in previous 12 months). 3. Patient has used antibiotics within the past 7 days from the baseline/screening visit. 4. Patient diagnosed with neurogenic LUTD (i.e., 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). 5. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS). 6. Patient with a urostomy. 7. Patient with a colostomy. 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) that the principal investigator deems might compromise the placement or retention of the Glean sensors during the study (e.g., strictures). 9. 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). 10. Patient with any abnormal or concerning rectal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, or active yeast infections. 11. Patient has a known inability to void. 12. Patient has a previous history of radiation leading to bleeding (e.g., hemorrhagic radiation cystitis). 13. Patient is pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months, or intending to become pregnant during the study period. 14. Patients who may not be able to independently use a smart device. 15. 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chesapeake Urology Associates
RECRUITINGHanover, Maryland, 21076, United States
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Chesapeake Urology Associates
RECRUITINGOwings Mills, Maryland, 21117, United States
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MetroHealth
RECRUITINGCleveland, Ohio, 44109, United States
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Sanford Health
RECRUITINGSioux Falls, South Dakota, 57105, United States
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Southern Urogynecology Wellness & Aesthetics
RECRUITINGWest Columbia, South Carolina, 29169, United States
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Urology Partner of North Texas
RECRUITINGArlington, Texas, 76017, United States
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Urology of St. Louis
RECRUITINGSt Louis, Missouri, 63141, United States
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- Can new home monitors keep tabs on breathing support without a clinic visit?
- Kegel app vs. clinic visits: which works better for bladder leaks?