Modern Urodynamics System Efficacy (MUSE) Study

NCT05959655 | Completed Results FDA Device

• 1 other identifier: CIP-0005
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Lower Urinary Tract Dysfunction; Urinary Incontinence; Overactive Bladder; Urodynamics; Uroflowmetry

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Insertion Success

  Percent of insertion attempts of the Glean sensor deemed successful

  during the insertion procedure of a device

• Percentage of Participants With a Device-related SAE

  Device-related serious adverse events

  up to 2 weeks

• Percentage of Participants With Removal Success

  Percent of removal attempts of the Glean sensor deemed successful

  during the removal procedure of a device

Secondary Outcomes (1)

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

  asked at end of Glean Urodynamics procedure

Study Arms (1)

Glean Urodynamics System

EXPERIMENTAL

Wireless, catheter-free urodynamics system

Device: Glean Urodynamics System

Interventions

Glean Urodynamics System DEVICE

Wireless, catheter-free urodynamics system

Also known as: GUS

Glean Urodynamics System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bright Uro: lead

Study Sites (5)

Tri Valley Urology

Murrieta, California, 92562, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Stony Brook Medicine

East Setauket, New York, 11733, United States

Location

Palmetto Adult and Children's Urology

North Charleston, South Carolina, 29406, United States

Location

Urology Partners of North Texas

Arlington, Texas, 76017, United States

Location

Related Publications (2)

• 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.

  PMID: 37293725 BACKGROUND

• Kim J, Xavier K, Cannon-Smith T, Vaughan T, Vemulapalli S, Zhao H, Aalami-Harandi A, Shah N. The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study. J Endourol. 2025 Jun;39(6):625-634. doi: 10.1089/end.2025.0270. Epub 2025 May 2.

  PMID: 40314068 RESULT

MeSH Terms

Conditions

Urologic Diseases; Urinary Incontinence; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study not powered for any outcome or any comparisons; small sample size limits validity, generalizability, and applicability; order of procedures (i.e., conventional UDS occurring before Glean UDS) and the variability of standard-of-care may have influenced results such as attribution of harm; and participant recall bias due to the removal of the Glean sensor being the last procedure experienced (Kim, 2025).

Results Point of Contact

• Title: Brittany Carter
• Organization: Bright Uro

brittany@brighturo.com

9492025689

Study Officials

• Brittany Carter, DHSc, MPH

  Bright Uro

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 25, 2023
• Study Start: August 21, 2023
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)