Actively Recruiting
Ambulatory Long Length URodynamics Evaluation
Led by Bright Uro · Updated on 2026-04-15
101
Participants Needed
7
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ambulatory Long Length URodynamics Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient must be 63 22 years of age.
- Patient is a candidate for UDS per standard of care.
- Patient is able to provide informed consent.
You will not qualify if you...
- Patient has symptoms of a urinary tract infection such as fever, pain, or worsening urinary symptoms.
- Patient has had three or more urinary tract infections in the past 12 months.
- Patient has used antibiotics within 7 days before baseline screening.
- Patient diagnosed with neurogenic lower urinary tract dysfunction including conditions like cerebral palsy, spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, or dementia.
- Patient diagnosed with interstitial cystitis, bladder pain syndrome, or chronic pelvic pain syndrome.
- Patient has a urostomy or colostomy.
- Patient has structural changes or previous surgery altering the lower urinary tract anatomy that may affect device placement.
- Patient has Pelvic Organ Prolapse Quantification Grade III or higher.
- Patient has abnormal rectal conditions such as anal fissures, fistulas, or active infections.
- Patient has a known inability to urinate.
- Patient has a history of radiation causing bleeding in the bladder.
- Patient is pregnant, breastfeeding, recently pregnant within 6 months, or plans pregnancy during the study.
- Patient may not be able to use a smart device independently.
- Patients deemed inappropriate for the study by the principal investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Chesapeake Urology Associates
Hanover, Maryland, United States, 21076
Actively Recruiting
2
Chesapeake Urology Associates
Owings Mills, Maryland, United States, 21117
Actively Recruiting
3
Urology of St. Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
4
MetroHealth
Cleveland, Ohio, United States, 44109
Actively Recruiting
5
Southern Urogynecology Wellness & Aesthetics
West Columbia, South Carolina, United States, 29169
Actively Recruiting
6
Sanford Health
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
7
Urology Partner of North Texas
Arlington, Texas, United States, 76017
Actively Recruiting
Research Team
B
Brittany U Carter, DHSc, MPH
CONTACT
S
Suranjan Roychowdhury, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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