Ambulatory Long Length URodynamics Evaluation
Bright Uro
Summary
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.
Description
Subjects will have the Glean Urodynamics System inserted for an in-clinic ambulatory monitoring period. Afterward, they will be discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, not exceeding 24 hours. The sensor will be removed within 24 hours of insertion. Subjects will provide a urine sample 7 days after sensor removal and will receive a follow-up phone call 14 days post-removal.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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. P…
Interventions
- DeviceGlean Urodynamics System
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.
Locations (7)
- Chesapeake Urology AssociatesHanover, Maryland
- Chesapeake Urology AssociatesOwings Mills, Maryland
- Urology of St. LouisSt Louis, Missouri
- MetroHealthCleveland, Ohio
- Southern Urogynecology Wellness & AestheticsWest Columbia, South Carolina
- Sanford HealthSioux Falls, South Dakota