Urologic DiseasesMUSENCT05959655

Modern Urodynamics System Efficacy (MUSE) Study

A study testing Glean Urodynamics System in people with Urologic Diseases and Urodynamics, run by Bright Uro at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urologic Diseases, Urodynamics
What is being tested?: Glean Urodynamics System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 5 sitesUnited States
Study dates: 21 Aug 2023to 18 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

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

Other trials in United States

About this study

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
Being tested: Glean Urodynamics System
Keywords: Lower Urinary Tract Dysfunction, Urinary Incontinence, Overactive Bladder, Urodynamics, Uroflowmetry
Medical subject headings: Urologic Diseases, Urinary Incontinence, Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Glean Urodynamics SystemDevice
Also called GUS
Wireless, catheter-free urodynamics system

Study groups in NCT05959655
Study group	Role	What they receive
Glean Urodynamics System	Experimental	Wireless, catheter-free urodynamics system Receives: Device: Glean Urodynamics System

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Insertion Success
Percent of insertion attempts of the Glean sensor deemed successful
Measured: during the insertion procedure of a device
Percentage of Participants With a Device-related SAE
Device-related serious adverse events
Measured: up to 2 weeks
Percentage of Participants With Removal Success
Percent of removal attempts of the Glean sensor deemed successful
Measured: 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
Measured: asked at end of Glean Urodynamics procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Aug 202318 Apr 2024

First posted25 Jul 2023
Study start21 Aug 2023
Primary completion18 Apr 2024
Study completion18 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Urologic DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05959655
Sponsor's protocol ID: CIP-0005
Acronym: MUSE
Status last verified: Dec 2025
First submitted: 7 Jul 2023
Last updated: 18 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 3
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruitingEarly Phase 1
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
Bladder Cancer

All Urologic Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modern Urodynamics System Efficacy (MUSE) Study
ClinicalTrials.gov ID: NCT05959655
Acronym / sponsor ID: MUSE / CIP-0005
Conditions: Urologic Diseases, Urodynamics
Keywords: Lower Urinary Tract Dysfunction, Urinary Incontinence, Overactive Bladder, Urodynamics, Uroflowmetry
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Bright UroIndustry (pharma, biotech, devices)
Study start: 21 Aug 2023 (actual)
Primary completion: 18 Apr 2024 (actual)
Study completion: 18 Apr 2024 (actual)
First posted: 25 Jul 2023 (actual)
Results: Posted 18 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Glean Urodynamics System	Experimental	Device: Glean Urodynamics SystemWireless, catheter-free urodynamics system

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Glean Urodynamics SystemAlso: GUSWireless, catheter-free urodynamics system	Device	Glean Urodynamics System

Primary outcome

Percentage of Participants With Insertion Success
Time frame: during the insertion procedure of a device
Percent of insertion attempts of the Glean sensor deemed successful
Percentage of Participants With a Device-related SAE
Time frame: up to 2 weeks
Device-related serious adverse events
Percentage of Participants With Removal Success
Time frame: during the removal procedure of a device
Percent of removal attempts of the Glean sensor deemed successful

1 secondary outcome

Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable
Time frame: asked at end of Glean Urodynamics procedure

Results and safety

Results posted to the registry on 18 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glean Urodynamics System	38	28

Primary outcome: Percentage of Participants With Insertion Success

Time frame: during the insertion procedure of a device. Count of participants. Unit: Participants

Measure	Glean Urodynamics System n = 33
Value	32

Population analysed: 33/34 participants who underwent conventional urodynamics underwent an insertion attempt with the Glean Urodynamics System.

Primary outcome: Percentage of Participants With a Device-related SAE

Time frame: up to 2 weeks. Count of participants. Unit: Participants

Measure	Glean Urodynamics System n = 32
Value	0

Population analysed: Number of participants undergoing Glean Urodynamics

Primary outcome: Percentage of Participants With Removal Success

Time frame: during the removal procedure of a device. Count of participants. Unit: Participants

Measure	Glean Urodynamics System n = 32
Value	32

Population analysed: 32 participants had Glean successfully inserted and thus all had a successful removal.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 38 (0%)	12 of 38 (31.6%)	0 of 38
Glean Urodynamics System	0 of 32 (0%)	7 of 32 (21.9%)	0 of 32

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37293725Frainey 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.
Results publication: PubMed 40314068Kim 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.
Individual participant dataSharing planned: No

Related trials for Urologic Diseases

Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 3
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruitingEarly Phase 1
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
Bladder Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brittany Carter, DHSc, MPH study director

Bright Uro

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Glean Urodynamics System in people with Urologic Diseases and Urodynamics, run by Bright Uro at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Insertion Success (time frame: during the insertion procedure of a device). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05959655, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.