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NCT07425015From ClinicalTrials.govRecruiting

Ambulatory Long Length URodynamics Evaluation

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

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Bright Uro
Enrolment target
101
Started
17 February 2026
Main results due
June 2027
Study sites
9
Registry updated
28 September 2026

Can you take part?

  • Aged 22 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

1. 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).
2. Patient has a history of recurrent UTIs (≥ 3 episodes in previous 12 months).
3. Patient has used antibiotics within the past 7 days from the baseline/screening visit.
4. 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).
5. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).
6. Patient with a urostomy.
7. Patient with a colostomy.
8. 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).
9. 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).
10. Patient with any abnormal or concerning rectal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, or active yeast infections.
11. Patient has a known inability to void.
12. Patient has a previous history of radiation leading to bleeding (e.g., hemorrhagic radiation cystitis).
13. 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.
14. Patients who may not be able to independently use a smart device.
15. Subjects who, at the principal investigator's determination, would not be appropriate for this study.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(9)

  • Ochsner Clinic Foundation Research

    New Orleans, Louisiana, United States

    Recruiting

  • Chesapeake Urology Associates

    Hanover, Maryland, United States

    Recruiting

  • Chesapeake Urology Associates

    Owings Mills, Maryland, United States

    Recruiting

  • Urology of St. Louis

    St Louis, Missouri, United States

    Recruiting

  • MetroHealth

    Cleveland, Ohio, United States

    Recruiting

  • Southern Urogynecology Wellness & Aesthetics

    West Columbia, South Carolina, United States

    Recruiting

  • Sanford Health

    Sioux Falls, South Dakota, United States

    Recruiting

  • Urology Partner of North Texas

    Arlington, Texas, United States

    Recruiting

  • Surgical Associates Northwest Urology

    Auburn, Washington, United States

    Recruiting

Showing 9 of 9 sites. 9 of the 9 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07425015. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Ambulatory Long Length URodynamics Evaluation | Trialion