Ambulatory Long Length URodynamics Evaluation
Bright Uro · NCT07425015
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 101
- US sites recruiting
- 9
- Study start
- February 17, 2026
- Record last updated
- September 28, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Glean Urodynamics System
Conditions: Urology; Urinary Bladder, Overactive; Benign Prostatic Hyperplasia; Urodynamics; Home Monitoring; Urinary Incontinence (UI); Lower Urinary Tract Dysfunction
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Ochsner Clinic Foundation Research
New Orleans, LA 70121
Site contact: CRC · 504-842-2455 · samantha.ahrens@ochsner.org
Chesapeake Urology Associates
Hanover, MD 21076
Site contact: Clinical Research Coordinator · 410-760-9400
Chesapeake Urology Associates
Owings Mills, MD 21117
Site contact: Clinical Research Coordinator · 410-581-8140
Urology of St. Louis
St Louis, MO 63141
Site contact: Clinical Research Coordinator · 314-567-6071
MetroHealth
Cleveland, OH 44109
Site contact: Clinical Research Manager · 216-778-8445 · sbaker3@metrohealth.org
Southern Urogynecology Wellness & Aesthetics
West Columbia, SC 29169
Site contact: Clinical Research Coordinator · 803-457-7000 · tmcgready@southurogyn.com
Sanford Health
Sioux Falls, SD 57105
Site contact: Research Compliance Specialist · 605-328-1383 · nicole.arbach@sanfordhealth.org
Urology Partner of North Texas
Arlington, TX 76017
Site contact: Clinical Research Coordinator · 682-205-8396 · gyoon@folioclinicalresearch.com
Surgical Associates Northwest Urology
Auburn, WA 98001
Site contact: CEO · 424-298-2783 · ewenson@folioclinicalresearch.com
Study contacts (from the official record)
- Brittany U Carter, DHSc, MPH · 949-202-5689 · brittany@brighturo.com
- Suranjan Roychowdhury, PhD · 949-202-5685 · suranjan@brighturo.com