RecruitingNot Applicable

Ambulatory Long Length URodynamics Evaluation

United States101 participantsStarted 2026-02-17

Plain-language summary

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.

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).

What they're measuring

Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System

Timeframe: From enrollment to 14 days after device removal

Trial details

NCT IDNCT07425015

SponsorBright Uro

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Brittany U Carter, DHSc, MPH

949-202-5689 brittany@brighturo.com

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