Extended ambulatory bladder monitoring with the Glean Urodynamics System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ochsner Clinic Foundation Research
  New Orleans, Louisiana, 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

Study contacts

• Study coordinator: Brittany U Carter, DHSc, MPH
• Email: brittany@brighturo.com
• Phone: 949-202-5689

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.