Clinical trial NCT05694793: Trial for Reliability of Urodynamics SysTem
Official title: Trial for Reliability of Urodynamics SysTem
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urologic Diseases
Urodynamics
Keywords: Lower Urinary Tract Dysfunction
Urinary Incontinence
Overactive Bladder
Home Monitoring
Urodynamics
Uroflowmetry
Lead sponsor: Bright Uro
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-01-23
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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 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

Primary outcomes:
measure: Safety
timeFrame: From date of enrollment to study exit (up to 43 days)
Secondary outcomes:
measure: Vesical pressure
timeFrame: during the procedure/surgery
Other outcomes:
Locations:
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Torrence
country: United States
facility: Unio Health Partners
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
citation: Frainey BT, Majerus SJA, Derisavifard S, Lewis KC, Williams AR, Balog BM, Butler RS, Goldman HB, Damaser MS. First in Human Subjects Testing of the UroMonitor: A Catheter-free Wireless Ambulatory Bladder Pressure Monitor. J Urol. 2023 Jul;210(1):186-195. doi: 10.1097/JU.0000000000003451. Epub 2023 Jun 9.