CClinicalTrials.gg
RecruitingNCT07425015ALLUREUpdated Apr 15, 2026

Ambulatory Long Length URodynamics Evaluation

An interventional study of Glean Urodynamics System in Urology, Urinary Bladder, Overactive and Benign Prostatic Hyperplasia, sponsored by Bright Uro. Recruiting at 7 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Bright Uro · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study 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.

Read the 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 monitoring outside the clinic, not exceeding 24 hours. The sensor will be removed within 24 hours of insertion. Subjects will provide a urine sample 7 days after sensor removal and will receive a follow-up phone call 14 days post-removal.

02

Conditions studied

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

Keywords

  • Bright Uro
  • Glean Urodynamics System
  • Uroflowmetry
03

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
101 participants (estimated)

Study arms

  • Experimental
    Glean Urodynamics System

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

    Device: Glean Urodynamics System

Interventions

  • DeviceGlean Urodynamics System

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

05

What researchers measure

Primary outcomes

  1. Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System

    Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System

    Time frame: From enrollment to 14 days after device removal

06

Study locations

7 of 7 sites recruiting
  • Chesapeake Urology Associates
    Hanover, Maryland 21076, United States
    • Clinical Research Coordinator · Contact · 410-760-9400
    • Kaiser J Robertson III, MD · Principal investigator
    Recruiting
  • Chesapeake Urology Associates
    Owings Mills, Maryland 21117, United States
    • Clinical Research Coordinator · Contact · 410-581-8140
    • Laura L Giusto, MD · Principal investigator
    Recruiting
  • Urology of St. Louis
    St Louis, Missouri 63141, United States
    • Clinical Research Coordinator · Contact · 314-567-6071
    • Travis Bullock, MD · Principal investigator
    Recruiting
  • MetroHealth
    Cleveland, Ohio 44109, United States
    • Clinical Research Manager · Contact · sbaker3@metrohealth.org · 216-778-8445
    • Jeffrey Mangel, MD · Principal investigator
    Recruiting
  • Southern Urogynecology Wellness & Aesthetics
    West Columbia, South Carolina 29169, United States
    • Clinical Research Coordinator · Contact · tmcgready@southurogyn.com · 803-457-7000
    • Jessica Rueb, MD · Principal investigator
    • Andrea Pezzella, MD · Sub investigator
    Recruiting
  • Sanford Health
    Sioux Falls, South Dakota 57105, United States
    Recruiting
  • Urology Partner of North Texas
    Arlington, Texas 76017, United States
    • Clinical Research Coordinator · Contact · gyoon@folioclinicalresearch.com · 682-205-8396
    • Geoffrey Nuss, MD · Principal investigator
    • Keith Xavier, MD · Sub investigator
    • Tracy Cannon-Smith, MD · Sub investigator
    Recruiting
07

References and documents

Publications

  • Kim J, Xavier K, Cannon-Smith T, Vaughan T, Vemulapalli S, Zhao H, Aalami-Harandi A, Shah N. The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study. J Endourol. 2025 Jun;39(6):625-634. doi: 10.1089/end.2025.0270. Epub 2025 May 2. PubMed 40314068 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07425015
Lead sponsor
Bright Uro
Responsible party
Sponsor
First posted
Feb 20, 2026
Start date
Feb 17, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Apr 15, 2026

Study contacts

Brittany U Carter, DHSc, MPH
Contact
brittany@brighturo.com
949-202-5689
Suranjan Roychowdhury, PhD
Contact
suranjan@brighturo.com
949-202-5685
Brittany Carter, DHSc, MPH
study director · Bright Uro

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion