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Modern Urodynamics System Efficacy (MUSE) Study

Sponsor
Bright Uro (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05959655
Collaborator
(none)
50
Enrollment
23
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this prospective observational 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Glean Urodynamics System

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Modern Urodynamics System Efficacy (MUSE) Study
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Glean Urodynamics System

Wireless, catheter-free urodynamics system

Device: Glean Urodynamics System
Wireless, catheter-free urodynamics system
Other Names:
  • GUS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Insertion/Removal Success [during the procedure/surgery]

      Percent of insertion or removal attempts of the Glean sensor deemed successful

    2. Device-related SAE [up to 2 weeks]

      Device-related serious adverse events

    Secondary Outcome Measures

    1. Patient perception [during the procedure/surgery]

      Likert scale of comfort during Glean urodynamics; scale 1-5, higher scores are better

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bright Uro

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bright Uro
    ClinicalTrials.gov Identifier:
    NCT05959655
    Other Study ID Numbers:
    • CIP-0005
    First Posted:
    Jul 25, 2023
    Last Update Posted:
    Jul 25, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bright Uro
    Lower Urinary Tract Dysfunction
    Urinary Incontinence
    Overactive Bladder
    Urodynamics
    Uroflowmetry
    Additional relevant MeSH terms:
    Urologic Diseases

    Study Results

    No Results Posted as of Jul 25, 2023