Trial Outcomes & Findings for Modern Urodynamics System Efficacy (MUSE) Study (NCT NCT05959655)

NCT ID: NCT05959655

Last Updated: 2025-12-18

Results Overview

Percent of insertion attempts of the Glean sensor deemed successful

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: during the insertion procedure of a device
• Results posted on: 2025-12-18

Participant Flow

Participant milestones

Measure	Glean Urodynamics System Wireless, catheter-free urodynamics system Glean Urodynamics System: Wireless, catheter-free urodynamics system
Overall Study STARTED	38
Overall Study Underwent Conventional UDS	34
Overall Study Underwent Glean Urodynamics	32
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modern Urodynamics System Efficacy (MUSE) Study

Baseline characteristics by cohort

Measure	Glean Urodynamics System n=38 Participants Wireless, catheter-free urodynamics system
Age, Customized Age	64 Years n=47 Participants
Sex: Female, Male Female	17 Participants n=47 Participants
Sex: Female, Male Male	21 Participants n=47 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=47 Participants
Race (NIH/OMB) Asian	0 Participants n=47 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants
Race (NIH/OMB) Black or African American	6 Participants n=47 Participants
Race (NIH/OMB) White	32 Participants n=47 Participants
Race (NIH/OMB) More than one race	0 Participants n=47 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=47 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=47 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=47 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=47 Participants

PRIMARY outcome

Timeframe: during the insertion procedure of a device

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

Percent of insertion attempts of the Glean sensor deemed successful

Outcome measures

Measure	Glean Urodynamics System n=33 Participants Wireless, catheter-free urodynamics system
Percentage of Participants With Insertion Success	32 Participants

PRIMARY outcome

Timeframe: up to 2 weeks

Population: Number of participants undergoing Glean Urodynamics

Device-related serious adverse events

Outcome measures

Measure	Glean Urodynamics System n=32 Participants Wireless, catheter-free urodynamics system
Percentage of Participants With a Device-related SAE	0 Participants

PRIMARY outcome

Timeframe: during the removal procedure of a device

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

Percent of removal attempts of the Glean sensor deemed successful

Outcome measures

Measure	Glean Urodynamics System n=32 Participants Wireless, catheter-free urodynamics system
Percentage of Participants With Removal Success	32 Participants

SECONDARY outcome

Timeframe: asked at end of Glean Urodynamics procedure

Population: Number of participants who experienced Glean Urodynamics and completed the survey at the end of the urodynamics study visit

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

Outcome measures

Measure	Glean Urodynamics System n=31 Participants Wireless, catheter-free urodynamics system
Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable	13 Participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Glean Urodynamics System

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=38 participants at risk All participants enrolled in the study	Glean Urodynamics System n=32 participants at risk Among those who underwent Glean Urodynamics
Renal and urinary disorders Gross Hematuria	23.7% 9/38 • Number of events 9 • From enrollment until end of follow-up, up to 2 weeks	12.5% 4/32 • Number of events 4 • From enrollment until end of follow-up, up to 2 weeks
Renal and urinary disorders Genitourinary pain or discomfort	5.3% 2/38 • Number of events 2 • From enrollment until end of follow-up, up to 2 weeks	6.2% 2/32 • Number of events 2 • From enrollment until end of follow-up, up to 2 weeks
Renal and urinary disorders Dysuria	5.3% 2/38 • Number of events 2 • From enrollment until end of follow-up, up to 2 weeks	3.1% 1/32 • Number of events 1 • From enrollment until end of follow-up, up to 2 weeks

Additional Information

Brittany Carter

Bright Uro

Phone: 9492025689

Email: brittany@brighturo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place