Modern Urodynamics System Efficacy (MUSE) Study

Bright Uro38 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Urologic Diseases Urodynamics

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Tri Valley Urology

Murrieta, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Stony Brook Medicine

East Setauket, New York, United States

Palmetto Adult and Children's Urology

North Charleston, South Carolina, United States

Urology Partners of North Texas

Arlington, Texas, United States

Outcomes

Primary Outcomes

Percentage of Participants With Insertion Success

Percent of insertion attempts of the Glean sensor deemed successful

Time frame: during the insertion procedure of a device

Percentage of Participants With a Device-related SAE

Device-related serious adverse events

Time frame: up to 2 weeks

Percentage of Participants With Removal Success

Percent of removal attempts of the Glean sensor deemed successful

Time frame: during the removal procedure of a device

Secondary Outcomes

Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable

Number of participants rating the overall comfort of Glean Urodynamics at comfortable or extremely comfortable

Time frame: asked at end of Glean Urodynamics procedure