Urodynamics, Urologic Diseases
Conditions
Keywords
Lower Urinary Tract Dysfunction, Urinary Incontinence, Overactive Bladder, Home Monitoring, Urodynamics, Uroflowmetry
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.
Interventions
DEVICEGlean Urodynamics System
Wireless, catheter-free urodynamics system
Sponsors
Bright Uro
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | From date of enrollment to study exit (up to 43 days) | Proportion of participants experiencing a qualifying adverse event attributable to the investigational device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vesical pressure | during the procedure/surgery | Vesical pressure |
Countries
United States
Outcome results
None listed