Trial for Reliability of Urodynamics SysTem

Launched by BRIGHT URO · Jan 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Glean Urodynamics System (GUS) to see how safely and effectively it can monitor bladder pressure without using a catheter. The trial is focused on adult women who experience symptoms related to urinary issues. Researchers want to compare the results from GUS with standard testing methods to find out if GUS is a reliable alternative for these assessments.

To participate, women must be at least 18 years old and recommended for urodynamic testing, which is a procedure that checks how well the bladder and urethra are working. However, some women may not be eligible, such as those who are pregnant, have a current urinary tract infection, or certain other medical conditions. If you join the study, you'll undergo several types of tests, including traditional urodynamics and the new GUS method, so that researchers can gather information about how well GUS performs. This study is currently recruiting participants, and your involvement could help improve future bladder health assessments.

Gender

FEMALE

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 injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine).
• • 6. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).
• • 7. Patient with a urostomy.
• • 8. 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).
• • 9. Patient who has from one or more major strictures in the urethra.
• • 10. Patient has a Pelvic Organ Prolapse Quantification (POP-Q) of Grade III or higher (i.e., most distal portion of the prolapse protrudes more than 1 centimeter below the hymen).
• • 11. Patient with a colostomy.
• • 12. Patient with any abnormal or concerning rectal or vaginal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, active yeast infections, or vaginitis.
• • 13. Patient has a known inability to void or is in complete retention.
• • 14. Subjects who, at the principal investigator's determination, would not be appropriate for this study