Recruiting

Glean Urodynamics System

Sponsor:

Bright Uro

Code:

NCT07425015

Conditions

Urology

Urinary Bladder, Overactive

Benign Prostatic Hyperplasia

Urodynamics

Home Monitoring

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Glean Urodynamics System

Study Details

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.

Conditions

Urology

Urinary Bladder, Overactive

Benign Prostatic Hyperplasia

Urodynamics

Home Monitoring

Study ID

NCT07425015

Start date

Feb 17, 2026

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

101 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Glean Urodynamics System

Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.

Interventions

Glean Urodynamics System

Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.

Primary outcome measure

  • Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System [ Time Frame: From enrollment to 14 days after device removal ]

Central Contacts and Locations

Central contacts

Brittany U Carter, DHSc, MPH

949-202-5689brittany@brighturo.com

Suranjan Roychowdhury, PhD

949-202-5685suranjan@brighturo.com

Locations

Chesapeake Urology Associates

Recruiting

Hanover, Maryland, United States, 21076

Contacts

Clinical Research Coordinator

410-760-9400

Principal Investigator:

Kaiser J Robertson III, MD

Chesapeake Urology Associates

Recruiting

Owings Mills, Maryland, United States, 21117

Contacts

Clinical Research Coordinator

410-581-8140

Principal Investigator:

Laura L Giusto, MD

Urology of St. Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Clinical Research Coordinator

314-567-6071

Principal Investigator:

Travis Bullock, MD

MetroHealth

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Clinical Research Manager

216-778-8445sbaker3@metrohealth.org

Principal Investigator:

Jeffrey Mangel, MD

Southern Urogynecology Wellness & Aesthetics

Recruiting

West Columbia, South Carolina, United States, 29169

Contacts

Clinical Research Coordinator

803-457-7000tmcgready@southurogyn.com

Principal Investigator:

Jessica Rueb, MD

Sanford Health

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Research Compliance Specialist

605-328-1383nicole.arbach@sanfordhealth.org

Principal Investigator:

Kevin Benson, MD

Urology Partner of North Texas

Recruiting

Arlington, Texas, United States, 76017

Contacts

Principal Investigator:

Geoffrey Nuss, MD

More Information

Sponsor

Bright Uro

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Bright Uro
  • Glean Urodynamics System
  • Uroflowmetry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bright Uro on 2026-04-15.