Modern Urodynamics System Efficacy (MUSE) Study (MUSE)

December 3, 2025 updated by: Bright Uro

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Murrieta, California, United States, 92562
        • Tri Valley Urology
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
    • New York
      • East Setauket, New York, United States, 11733
        • Stony Brook Medicine
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Palmetto Adult and Children's Urology
    • Texas
      • Arlington, Texas, United States, 76017
        • Urology Partners of North Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Adult males and females with lower urinary tract symptoms

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glean Urodynamics System
Wireless, catheter-free urodynamics system
Device: Glean Urodynamics System
Wireless, catheter-free urodynamics system
Other Names:
  • GUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Insertion Success
Time Frame: during the insertion procedure of a device
Percent of insertion attempts of the Glean sensor deemed successful
during the insertion procedure of a device
Percentage of Participants With a Device-related SAE
Time Frame: up to 2 weeks
Device-related serious adverse events
up to 2 weeks
Percentage of Participants With Removal Success
Time Frame: during the removal procedure of a device
Percent of removal attempts of the Glean sensor deemed successful
during the removal procedure of a device

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable
Time Frame: asked at end of Glean Urodynamics procedure
Number of participants rating the overall comfort of Glean Urodynamics at comfortable or extremely comfortable
asked at end of Glean Urodynamics procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bright Uro

Investigators

  • Study Director: Brittany Carter, DHSc, MPH, Bright Uro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2023

Primary Completion (Actual)

April 18, 2024

Study Completion (Actual)

April 18, 2024

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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