Ambulatory Long Length URodynamics Evaluation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorBright Uro

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Glean Urodynamics System

Treatment groups

101 Participants
are divided into 1 treatment group

Sponsors and collaborators