Ambulatory Long Length URodynamics Evaluation (ALLURE)

April 13, 2026 updated by: Bright Uro
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Hanover, Maryland, United States, 21076
        • Recruiting
        • Chesapeake Urology Associates
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 410-760-9400
        • Principal Investigator:
          • Kaiser J Robertson III, MD
      • Owings Mills, Maryland, United States, 21117
        • Recruiting
        • Chesapeake Urology Associates
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 410-581-8140
        • Principal Investigator:
          • Laura L Giusto, MD
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Urology of St. Louis
        • Principal Investigator:
          • Travis Bullock, MD
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 314-567-6071
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth
        • Principal Investigator:
          • Jeffrey Mangel, MD
        • Contact:
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Recruiting
        • Southern Urogynecology Wellness & Aesthetics
        • Contact:
        • Principal Investigator:
          • Jessica Rueb, MD
        • Sub-Investigator:
          • Andrea Pezzella, MD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Health
        • Principal Investigator:
          • Kevin Benson, MD
        • Contact:
    • Texas
      • Arlington, Texas, United States, 76017
        • Recruiting
        • Urology Partner of North Texas
        • Principal Investigator:
          • Geoffrey Nuss, MD
        • Contact:
        • Sub-Investigator:
          • Keith Xavier, MD
        • Sub-Investigator:
          • Tracy Cannon-Smith, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glean Urodynamics System
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.
Device: Glean Urodynamics System
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bright Uro

Investigators

  • Study Director: Brittany Carter, DHSc, MPH, Bright Uro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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