NCT05694793 Trial for Reliability of Urodynamics SysTem

Trial Parameters

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Brief Summary

The goal of this prospective trial is to assess the safety and reliability of the Glean Urodynamics System (GUS) in adult females with lower urinary tract symptoms. The main question\[s\] it aims to answer are: • What is GUS's ability to safely and reliably conduct wireless, catheter-free monitoring of vesical pressure compared to the vesical pressures collected with conventional urodynamics? Participants will undergo a conventional urodynamics exam, a simultaneous urodynamics exam with GUS, ambulatory urodynamics with GUS, and extended home monitoring with GUS. Researchers will compare GUS data with that from a conventional urodynamics exam.

Eligibility Criteria

Inclusion Criteria: 1. Female patient must be ≥ 18 years of age 2. Patient is a candidate for urodynamics per standard of care 3. Patient or patient's legally authorized representative is able to provide informed consent Exclusion Criteria: 1. Pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period 2. 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). 3. Patient has history of recurrent UTIs (≥ 3 episodes in previous 12 months). 4. Patient has used antibiotics within the past 7 days from the baseline/screening visit. 5. Patient diagnosed with neurogenic LUTS (which may be associated with one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain

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