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OpenTrials
Completed

NCT Number: NCT05959655

Modern Urodynamics System Efficacy (MUSE) Study

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.

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Key information

Conditions

Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urodynamics Urogenital Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri Valley Urology, Murrieta, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glean Urodynamics System

Device

Wireless, catheter-free urodynamics system

Other names: GUS

Primary outcomes

  1. 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

  2. Percentage of Participants With a Device-related SAE

    Time frame: up to 2 weeks

    Device-related serious adverse events

  3. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bright Uro

Industry

Registry information

Acronym: MUSE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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