Trial for Reliability of Urodynamics SysTem (TRUST-1)

Bright Uro

Status: Enrolling

Conditions: Urodynamics; Urologic Diseases

Treatments: Device: Glean Urodynamics System

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT05694793

CIP-0006

1R44DK131700 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Glean Urodynamics System

Experimental group

Treatment:

Device: Glean Urodynamics System

Device: Glean Urodynamics System