UrologyALLURENCT07425015
Ambulatory Long Length URodynamics Evaluation
A study testing Glean Urodynamics System in people with Urology and Urinary Bladder, Overactive, run by Bright Uro at 9 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Urology, Urinary Bladder, Overactive, Benign Prostatic Hyperplasia
- What is being tested?
- Glean Urodynamics System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 Feb 2026to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Urology Partner of North Texas
Arlington, Texas, 76017
Clinical Research Coordinator, 682-205-8396, gyoon@folioclinicalresearch.com
Geoffrey Nuss, MD
- Recruiting
Surgical Associates Northwest Urology
Auburn, Washington, 98001
CEO, 424-298-2783, ewenson@folioclinicalresearch.com
Stephen King, MD
- Recruiting
MetroHealth
Cleveland, Ohio, 44109
Clinical Research Manager, 216-778-8445, sbaker3@metrohealth.org
Jeffrey Mangel, MD
- Recruiting
Chesapeake Urology Associates
Hanover, Maryland, 21076
Clinical Research Coordinator, 410-760-9400
Kaiser J Robertson III, MD
- Recruiting
Ochsner Clinic Foundation Research
New Orleans, Louisiana, 70121
CRC, 504-842-2455, samantha.ahrens@ochsner.org
Colin Goudelocke, MD
- Recruiting
Chesapeake Urology Associates
Owings Mills, Maryland, 21117
Clinical Research Coordinator, 410-581-8140
Laura L Giusto, MD
- Recruiting
Sanford Health
Sioux Falls, South Dakota, 57105
Research Compliance Specialist, 605-328-1383, nicole.arbach@sanfordhealth.org
Kevin Benson, MD
- Recruiting
Urology of St. Louis
St Louis, Missouri, 63141
Clinical Research Coordinator, 314-567-6071
Travis Bullock, MD
- Recruiting
Southern Urogynecology Wellness & Aesthetics
West Columbia, South Carolina, 29169
Clinical Research Coordinator, 803-457-7000, tmcgready@southurogyn.com
Jessica Rueb, MD
About this study
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.
- Conditions
- Urology, Urinary Bladder, Overactive, Benign Prostatic Hyperplasia, Urodynamics, Home Monitoring, Urinary Incontinence (UI)
- Being tested
- Glean Urodynamics System
- Keywords
- Bright Uro, Glean Urodynamics System, Uroflowmetry
- Medical subject headings
- Urinary Bladder, Overactive, Prostatic Hyperplasia, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glean Urodynamics SystemDevice
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.
| Study group | Role | What they receive |
|---|---|---|
| Glean Urodynamics System | Experimental | Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps. Receives: Device: Glean Urodynamics System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 14 days after device removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start17 Feb 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bright Uro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brittany Carter, DHSc, MPH, Study director, Bright Uro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425015
- Sponsor's protocol ID
- CIP-0008
- Acronym
- ALLURE
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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