Extended ambulatory bladder monitoring with the Glean Urodynamics System

Ambulatory Long Length URodynamics Evaluation

This will test whether the Glean Urodynamics System can safely monitor bladder function in adults who need urodynamic testing, both during a clinic visit and for up to 24 hours at home.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 101 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Bright Uro (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 7 sites (Hanover, Maryland and 6 other locations)
• Trial ID: NCT07425015 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, single-arm interventional trial of the Glean Urodynamics System. Participants will have the Glean system inserted for an in-clinic ambulatory monitoring period and then be discharged with the Glean bladder sensor in place for continued monitoring outside the clinic for no more than 24 hours. The sensor will be removed within 24 hours of insertion, and participants will provide a urine sample seven days after removal and receive a follow-up phone call 14 days post-removal. The study will record device performance measures and monitor safety events related to the insertion and short-term ambulatory wear.

Who should consider this trial

Good fit: Adults aged 22 and older who are candidates for urodynamic testing and can give informed consent, and who do not have active UTI, recent antibiotics, neurogenic bladder disorders, or interstitial cystitis.

Not a fit: Patients with active or recurrent urinary tract infections, recent antibiotic use, diagnosed neurogenic lower urinary tract dysfunction, interstitial cystitis, or those who require monitoring beyond 24 hours are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could allow more natural, longer-duration bladder measurements outside the clinic and reduce the need for repeat or more invasive testing.

How similar studies have performed: Portable and ambulatory urodynamic devices have been explored in small prior studies showing feasibility, but larger clinical evidence specifically for the Glean system is limited.

Eligibility criteria

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.

Where this trial is running

Hanover, Maryland and 6 other locations

• Chesapeake Urology Associates — Hanover, Maryland, United States (Recruiting)
• Chesapeake Urology Associates — Owings Mills, Maryland, United States (Recruiting)
• Urology of St. Louis — St Louis, Missouri, United States (Recruiting)
• MetroHealth — Cleveland, Ohio, United States (Recruiting)
• Southern Urogynecology Wellness & Aesthetics — West Columbia, South Carolina, United States (Recruiting)
• Sanford Health — Sioux Falls, South Dakota, United States (Recruiting)
• Urology Partner of North Texas — Arlington, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Brittany U Carter, DHSc, MPH

Conditions Urology; Urinary Bladder, Overactive; Benign Prostatic Hyperplasia; Urodynamics; Home Monitoring; Urinary Incontinence; Lower Urinary Tract Dysfunction; Bright Uro