Ambulatory Long Length URodynamics Evaluation

Recruiting now · Not applicable

Conditions studied: Urology, Urinary Bladder, Overactive, Benign Prostatic Hyperplasia, Urodynamics, Home Monitoring, Urinary Incontinence (UI), Lower Urinary Tract Dysfunction

In brief

A prospective, open-label, single arm interventional trial evaluating the safety and performance of the in-clinic and extended monitoring of the lower urinary tract using the Glean Urodynamics System.

Key facts

Study ID

NCT07425015

Run by

Bright Uro

People needed

101

Starts

2026-02-17

Expected to finish

2027-06-01

Last updated by the study team

2026-04-15

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patient must be ≥ 22 years of age.
• Patient is a candidate for UDS per standard of care.
• Patient is able to provide informed consent.

You may not qualify if…

• 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 a 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 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).
• Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).
• Patient with a urostomy.
• Patient with a colostomy.
• 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).
• 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 any abnormal or concerning rectal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, or active yeast infections.
• Patient has a known inability to void.
• Patient has a previous history of radiation leading to bleeding (e.g., hemorrhagic radiation cystitis).
• 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.
• Patients who may not be able to independently use a smart device.
• Subjects who, at the principal investigator's determination, would not be appropriate for this study.

Where it is running

• Chesapeake Urology Associates — Hanover, Maryland, United States (enrolling)
• Chesapeake Urology Associates — Owings Mills, Maryland, United States (enrolling)
• Urology of St. Louis — St Louis, Missouri, United States (enrolling)
• MetroHealth — Cleveland, Ohio, United States (enrolling)
• Southern Urogynecology Wellness & Aesthetics — West Columbia, South Carolina, United States (enrolling)
• Sanford Health — Sioux Falls, South Dakota, United States (enrolling)
• Urology Partner of North Texas — Arlington, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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