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Ambulatory Long Length URodynamics Evaluation

Bright Uro · NCT07425015

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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
Ambulatory Long Length URodynamics Evaluation (NCT07425015) | Bored Studies