The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study.
Jason Kim, Keith Xavier, Tracy Cannon-Smith...
https://pubmed.ncbi.nlm.nih.gov/40314068Actively Recruiting
Phase Not Applicable
Age: 22Years +
All Genders
ID07425015
Ambulatory Long Length Urodynamics Evaluation for Lower Urinary Tract Monitoring with the Glean Urodynamics System
Led by Bright Uro · Updated on 2026-04-15
101
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Glean Urodynamics System for monitoring the lower urinary tract. This prospective, open-label, single-arm interventional trial focuses on both in-clinic and extended monitoring periods. The study aims to assess how well this device works in clinical settings and during continued use outside the clinic. Participants will have the Glean Urodynamics System inserted, which includes a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software applications. Initially, monitoring occurs in-clinic, followed by discharge with the bladder sensor in place for up to 24 hours of additional monitoring at home. The sensor is removed within 24 hours after insertion. Seven days following sensor removal, participants provide a urine sample and receive a follow-up phone call 14 days after the device is removed. During the study, participants will undergo monitoring with the device and provide a urine sample after one week. Researchers will track any adverse events related to the Glean Urodynamics System from the time of enrollment until 14 days after device removal. Follow-up phone calls help ensure participant safety and gather additional information. Participation duration includes the initial monitoring period, sample collection, and follow-up, lasting a few weeks in total.
CONDITIONS
Brief Title
Ambulatory Long Length URodynamics Evaluation
Who Can Participate
Age: 22Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patient 22 years of age or older
- Candidate for urodynamic studies based on standard medical care
- Able to provide informed consent
You will not qualify if you...
- Symptoms of urinary tract infection such as fever, pain, or worsening urinary symptoms
- History of recurrent urinary tract infections (3 or more episodes in past 12 months)
- Antibiotic use within 7 days before screening
- Diagnosis of neurogenic lower urinary tract dysfunction (conditions like hydrocephalus, cerebral palsy, spinal injuries, stroke, Parkinson's, multiple sclerosis, spina bifida, dementia, Guillain-Barre syndrome, CNS tumors)
- Diagnosis of interstitial cystitis, bladder pain syndrome, or chronic pelvic pain syndrome
- Presence of urostomy or colostomy
- Anatomic variations or previous surgeries that affect lower urinary tract structure and may interfere with device placement
- Pelvic organ prolapse Grade III or higher
- Rectal conditions such as anal fissures, rectocele, fistula, active herpes, or yeast infections
- Known inability to void
- History of radiation causing bladder bleeding
- Pregnant, breastfeeding, pregnant within past 6 months, or intending pregnancy during study
- Inability to independently use a smart device
- Any condition deemed inappropriate for study participation by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 24 hours
Participants have the Glean Urodynamics System device inserted for an in-clinic ambulatory monitoring period and are then discharged with the bladder sensor in place for continued monitoring outside the clinic, not exceeding 24 hours. The sensor is removed within 24 hours of insertion.
1 in-clinic visit for device insertion and monitoring, followed by device removal within 24 hours
Sample Collection
Duration - 1 day
Participants provide a urine sample 7 days after device removal.
1 visit (in-person) for urine sample collection
Follow-up
Duration - 1 day
Participants receive a follow-up phone call 14 days after device removal to assess safety and outcomes.
1 phone call
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
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Research Team
B
Brittany U Carter, DHSc, MPH
S
Suranjan Roychowdhury, PhD
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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