Glean: a wireless, catheter-free system to measure bladder pressure in adult women

Trial for Reliability of Urodynamics SysTem

This will test whether the Glean Urodynamics System can safely and reliably measure bladder (vesical) pressure without a catheter in adult women with lower urinary tract symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Bright Uro (Industry-sponsored)
• Locations: 4 sites (Murrieta, California and 3 other locations)
• Trial ID: NCT05694793 on ClinicalTrials.gov

What this trial studies

Participants will first undergo a conventional catheter-based urodynamics exam while the Glean device records pressures simultaneously, then will use Glean during ambulatory testing and extended home monitoring. Researchers will compare vesical pressure traces from the wireless, catheter-free Glean system to pressures recorded by standard urodynamics and record any device-related safety events. The protocol enrolls adult women who are candidates for urodynamics, includes in-person visits at three California sites, and collects longer-term home data to evaluate real-world performance. The study is sponsored by Bright Uro with collaboration from the NIDDK.

Who should consider this trial

Good fit: Adult females (18+) with lower urinary tract symptoms who are candidates for urodynamics and can provide informed consent are ideal candidates.

Not a fit: Patients who are pregnant or breastfeeding, have active or recurrent urinary tract infections, recent antibiotic use, or neurogenic bladder conditions are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, GUS could let women monitor bladder pressure without catheters, making testing more comfortable and enabling longer-term measurements to guide care.

How similar studies have performed: Catheter-free and ambulatory urodynamic technologies are relatively new with limited published validation, so this approach builds on promising but not yet widely proven methods.

Eligibility criteria

Inclusion Criteria:

1. Female patient must be ≥ 18 years of age
2. Patient is a candidate for urodynamics per standard of care
3. Patient or patient's legally authorized representative is able to provide informed consent

Exclusion Criteria:

1. Pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period
2. 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).
3. Patient has history of recurrent UTIs (≥ 3 episodes in previous 12 months).
4. Patient has used antibiotics within the past 7 days from the baseline/screening visit.
5. Patient diagnosed with neurogenic LUTS (which may be associated with 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).
6. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).
7. Patient with a urostomy.
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).
9. Patient who has from one or more major strictures in the urethra.
10. 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).
11. Patient with a colostomy.
12. Patient with any abnormal or concerning rectal or vaginal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, active yeast infections, or vaginitis.
13. Patient has a known inability to void or is in complete retention.
14. Subjects who, at the principal investigator's determination, would not be appropriate for this study

Where this trial is running

Murrieta, California and 3 other locations

• Tri Valley Urology Medical Group — Murrieta, California, United States (Recruiting)
• University of California San Diego — San Diego, California, United States (Completed)
• Unio Health Partners — Torrence, California, United States (Withdrawn)
• Cleveland Clinic — Cleveland, Ohio, United States (Completed)

Study contacts

• Study coordinator: Brittany Carter, DHSc

Conditions Urologic Diseases; Urodynamics; Lower Urinary Tract Dysfunction; Urinary Incontinence; Overactive Bladder; Home Monitoring; Uroflowmetry