Modern Urodynamics System Efficacy (MUSE) Study

Urologic Diseases Clinical Trial

Official title:

Modern Urodynamics System Efficacy (MUSE) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05959655
• Other study ID #: CIP-0005
• Status: Active, not recruiting
• Start date: August 21, 2023
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Bright Uro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urodynamics
• Urologic Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Urology Partners of North Texas	Arlington	Texas
United States	Stony Brook Medicine	East Setauket	New York
United States	Tri Valley Urology	Murrieta	California
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Palmetto Adult and Children's Urology	North Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bright Uro

Country where clinical trial is conducted

United States, 

References & Publications (1)

Frainey BT, Majerus SJA, Derisavifard S, Lewis KC, Williams AR, Balog BM, Butler RS, Goldman HB, Damaser MS. First in Human Subjects Testing of the UroMonitor: A Catheter-free Wireless Ambulatory Bladder Pressure Monitor. J Urol. 2023 Jul;210(1):186-195. doi: 10.1097/JU.0000000000003451. Epub 2023 Jun 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion/Removal Success	Percent of insertion or removal attempts of the Glean sensor deemed successful	during the procedure/surgery
Primary	Device-related SAE	Device-related serious adverse events	up to 2 weeks
Secondary	Patient perception	Likert scale of comfort during Glean urodynamics; scale 1-5, higher scores are better	during the procedure/surgery