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
- Are there results?
- Not yet: the study is under way
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.
Show all 15Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Long Length URodynamics Evaluation
- ClinicalTrials.gov ID
- NCT07425015
- Acronym / sponsor ID
- ALLURE / CIP-0008
- Conditions
- Urology, Urinary Bladder, Overactive, Benign Prostatic Hyperplasia, Urodynamics, Home Monitoring, Urinary Incontinence (UI)
- Keywords
- Bright Uro, Glean Urodynamics System, Uroflowmetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Bright UroIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glean Urodynamics System | Experimental | Device: Glean Urodynamics SystemGlean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glean Urodynamics SystemGlean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps. | Device | Glean Urodynamics System |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 40314068Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brittany Carter, DHSc, MPH study director
Bright Uro
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glean Urodynamics System in people with Urology and Urinary Bladder, Overactive, run by Bright Uro at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany U Carter, DHSc, MPH (949-202-5689, brittany@brighturo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.