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Modern Urodynamics System Efficacy (MUSE) Study

NCT05959655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-12-18

Study results available
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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

  • Urologic Diseases
  • Urodynamics

Interventions

DEVICE

Glean Urodynamics System

Wireless, catheter-free urodynamics system

Sponsors & Collaborators

  • Bright Uro

    lead INDUSTRY

Principal Investigators

  • Brittany Carter, DHSc, MPH · Bright Uro

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2024-04-18
Completion
2024-04-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05959655 on ClinicalTrials.gov