Trial for Reliability of Urodynamics SysTem (NCT05694793) | Clinical Trial Compass
RecruitingNot Applicable
Trial for Reliability of Urodynamics SysTem
United States28 participantsStarted 2025-06-03
Plain-language 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:
ā¢ 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Female patient must be ā„ 18 years of age
ā. Patient is a candidate for urodynamics per standard of care
ā. Patient or patient's legally authorized representative is able to provide informed consent
Exclusion criteria
ā. 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
ā. 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).
ā. Patient has history of recurrent UTIs (ā„ 3 episodes in previous 12 months).
ā. Patient has used antibiotics within the past 7 days from the baseline/screening visit.
ā. 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 injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine).
What they're measuring
1
Safety
Timeframe: From date of enrollment to study exit (up to 43 days)
ā. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).
ā. Patient with a urostomy.
ā. Patient has an atypical anatomic structural variation or has had a previous surgical intervention that has permanently changed structural anatomy anywhere along their lower urinary tract (urethra, pelvic floor, urethral sphincter, and/or bladder wall).