Status:
RECRUITING
Ambulatory Long Length URodynamics Evaluation
Lead Sponsor:
Bright Uro
Conditions:
Urology
Urinary Bladder, Overactive
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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.
Detailed Description
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 monitori...
Eligibility Criteria
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).
- 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.
Key Trial Info
Start Date :
February 17 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT07425015
Start Date
February 17 2026
End Date
June 1 2027
Last Update
April 15 2026
Active Locations (7)
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1
Chesapeake Urology Associates
Hanover, Maryland, United States, 21076
2
Chesapeake Urology Associates
Owings Mills, Maryland, United States, 21117
3
Urology of St. Louis
St Louis, Missouri, United States, 63141
4
MetroHealth
Cleveland, Ohio, United States, 44109