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CompletedNCT05959655MUSEUpdated Dec 18, 2025Results posted

Modern Urodynamics System Efficacy (MUSE) Study

An interventional study of Glean Urodynamics System in Urologic Diseases and Urodynamics, sponsored by Bright Uro. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by Bright Uro · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Urologic Diseases
  • Urodynamics

Keywords

  • Lower Urinary Tract Dysfunction
  • Urinary Incontinence
  • Overactive Bladder
  • Urodynamics
  • Uroflowmetry
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Glean Urodynamics System

    Wireless, catheter-free urodynamics system

    Device: Glean Urodynamics System

Interventions

  • DeviceGlean Urodynamics System

    Wireless, catheter-free urodynamics system

    Also known as: GUS

05

What researchers measure

Primary outcomes

  1. 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

  2. Percentage of Participants With a Device-related SAE

    Device-related serious adverse events

    Time frame: up to 2 weeks

  3. 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

  1. 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

06

Results

Posted Dec 18, 2025
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).

Participant flow

Participant flow — Overall Study
MilestoneGlean Urodynamics System
Started38
Underwent conventional uds34
Underwent glean urodynamics32
Completed28
Not completed10

Outcome measures

PrimaryPercentage of Participants With Insertion Success

Percent of insertion attempts of the Glean sensor deemed successful

Time frame:
during the insertion procedure of a device
Reported as:
Count of participants · Participants
Percentage of Participants With Insertion Success
ParticipantsGlean Urodynamics System
Percentage of Participants With Insertion Success32
PrimaryPercentage of Participants With a Device-related SAE

Device-related serious adverse events

Time frame:
up to 2 weeks
Reported as:
Count of participants · Participants
Percentage of Participants With a Device-related SAE
ParticipantsGlean Urodynamics System
Percentage of Participants With a Device-related SAE0
SecondaryPercentage 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
Reported as:
Count of participants · Participants
Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable
ParticipantsGlean Urodynamics System
Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable13
PrimaryPercentage of Participants With Removal Success

Percent of removal attempts of the Glean sensor deemed successful

Time frame:
during the removal procedure of a device
Reported as:
Count of participants · Participants
Percentage of Participants With Removal Success
ParticipantsGlean Urodynamics System
Percentage of Participants With Removal Success32

Adverse events

Collected over From enrollment until end of follow-up, up to 2 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Participants0/38 (0%)0/38 (0%)12/38 (31.6%)
Glean Urodynamics System0/32 (0%)0/32 (0%)7/32 (21.9%)
Most frequent other events
Most frequent other events
EventAll ParticipantsGlean Urodynamics System
Gross HematuriaRenal and urinary disorders9/384/32
Genitourinary pain or discomfortRenal and urinary disorders2/382/32
DysuriaRenal and urinary disorders2/381/32

Baseline characteristics

Participants enrolled in the study

Age, Customized
Age, Customized(Years)Glean Urodynamics System
Age64 (25 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)Glean Urodynamics System
Female17
Male21
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Glean Urodynamics System
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American6
White32
More than one race0
Unknown or Not Reported0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Glean Urodynamics System
Hispanic or Latino2
Not Hispanic or Latino35
Unknown or Not Reported1
07

Study locations

5 sites
  • Tri Valley Urology
    Murrieta, California 92562, United States
  • Hoag Memorial Hospital Presbyterian
    Newport Beach, California 92663, United States
  • Stony Brook Medicine
    East Setauket, New York 11733, United States
  • Palmetto Adult and Children's Urology
    North Charleston, South Carolina 29406, United States
  • Urology Partners of North Texas
    Arlington, Texas 76017, United States
08

References and documents

Publications

  • 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. PubMed 37293725 ↗
  • 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. PubMed 40314068 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 28, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT05959655
Lead sponsor
Bright Uro
Responsible party
Sponsor
First posted
Jul 25, 2023
Start date
Aug 21, 2023
Primary completion
Apr 18, 2024
Completion
Apr 18, 2024
Results posted
Dec 18, 2025
Last update
Dec 18, 2025

Study contacts

Brittany Carter, DHSc, MPH
study director · Bright Uro

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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