Modern Urodynamics System Efficacy (MUSE) Study
- Conditions
- UrodynamicsUrologic Diseases
- Interventions
- Device: Glean Urodynamics System
- Registration Number
- NCT05959655
- Lead Sponsor
- Bright Uro
- Brief Summary
The goal of this prospective 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Glean Urodynamics System Glean Urodynamics System Wireless, catheter-free urodynamics system
- Primary Outcome Measures
Name Time Method Device-related SAE up to 2 weeks Device-related serious adverse events
Insertion/Removal Success during the procedure/surgery Percent of insertion or removal attempts of the Glean sensor deemed successful
- Secondary Outcome Measures
Name Time Method Patient perception during the procedure/surgery Likert scale of comfort during Glean urodynamics; scale 1-5, higher scores are better
Trial Locations
- Locations (5)
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Stony Brook Medicine
🇺🇸East Setauket, New York, United States
Tri Valley Urology
🇺🇸Murrieta, California, United States
Urology Partners of North Texas
🇺🇸Arlington, Texas, United States
Palmetto Adult and Children's Urology
🇺🇸North Charleston, South Carolina, United States