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.
Male or female patient must be ≥ 22 years of age.
Patient is a candidate for UDS per standard of care.
Patient is able to provide informed consent.
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).
Patient has a history of recurrent UTIs (≥ 3 episodes in previous 12 months).
Patient has used antibiotics within the past 7 days from the baseline/screening visit.
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).
Single group
Glean Urodynamics System
DeviceGlean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.
Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System
Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System
