Trials / Completed
CompletedNCT05959655
Modern Urodynamics System Efficacy (MUSE) Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Bright Uro · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Glean Urodynamics System | Wireless, catheter-free urodynamics system |
Timeline
- Start date
- 2023-08-21
- Primary completion
- 2024-04-18
- Completion
- 2024-04-18
- First posted
- 2023-07-25
- Last updated
- 2025-12-18
- Results posted
- 2025-12-18
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05959655. Inclusion in this directory is not an endorsement.