Urologic Diseases Clinical Trial
Official title:
Modern Urodynamics System Efficacy (MUSE) Study
Verified date | April 2024 |
Source | Bright Uro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this prospective observational trial is to evaluate the feasibility, efficacy, and safety of the Glean Urodynamics System (GUS) for use in the clinic to collect vesical pressure data in adult males and females with lower urinary tract symptoms. The main question[s] it aims to answer are: • What is the feasibility, efficacy, and safety of GUS for use in clinical to collect vesical pressure data in adult males and females with lower urinary tract symptoms? Participants will undergo a planned conventional urodynamics exam after which the Glean Sensor will be inserted and ambulatory urodynamics will be performed with the sensor indwelling in the bladder after which the sensor will be removed.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female patient must be = 18 years of age - Patient must have a diagnosis of LUTD - Patient must be scheduled for or recommended for cUDS - Patient is able to tolerate 18Fr catheterization - Patient or patient's legally authorized representative is able to provide informed consent Exclusion Criteria: - Pregnant (as confirmed by urine pregnancy test) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period. - Patient has a symptomatic UTI based on CDC guidance (see below) - Subjects who, at the principal investigator's determination, would not be appropriate for this study. |
Country | Name | City | State |
---|---|---|---|
United States | Urology Partners of North Texas | Arlington | Texas |
United States | Stony Brook Medicine | East Setauket | New York |
United States | Tri Valley Urology | Murrieta | California |
United States | Hoag Memorial Hospital Presbyterian | Newport Beach | California |
United States | Palmetto Adult and Children's Urology | North Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Bright Uro |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insertion/Removal Success | Percent of insertion or removal attempts of the Glean sensor deemed successful | during the procedure/surgery | |
Primary | Device-related SAE | Device-related serious adverse events | up to 2 weeks | |
Secondary | Patient perception | Likert scale of comfort during Glean urodynamics; scale 1-5, higher scores are better | during the procedure/surgery |
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