Modern Urodynamics System Efficacy (MUSE) Study
Phase: NA
Conditions: Urologic Diseases, Urodynamics
Sponsor: Bright Uro

COVER PAGE 
 
Study Title: Modern Urodynamics System Efficacy (MUSE) Study 
NCT: NCT05959655 
Date of Document: 2023-06-28 

MUSE Study 
CIP-0005, Rev 01 
CIP-0005 
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Bright Uro - Proprietary and Confidential 
1 Protocol Synopsis 
Study Title 
Modern Urodynamics System Efficacy 
Short Title 
MUSE Study 
Study Sponsor 
Bright Uro 
Protocol Number 
CIP-0005 
Study Objective(s) 
The objectives of the present study are to evaluate the feasibility, efficacy, and safety of 
the GUS for use in the clinic to collect vesical pressure data. 
Study Design 
This is a prospective, observational trial collecting vesical pressure (Pves) and flow from 
the GUS and cUDS system in patients with Lower Urinary Tract Symptoms (LUTS). 
Phase 
Phase 0 
Estimated Study Period 
Up to 24 months 
Investigational Devices 
Glean Urodynamics System (GUS) 
Indications for Use/Intended 
Use 
Indications for Use: The GUS is indicated for standard Urodynamic tests such as 
Uroflowmetry (UF), Cystometrogram (CMG), Urethral Pressure Profile (UPP), and 
Micturition Studies (MS). 
Intended Use: The GUS is a Urodynamic Analyzer system that is intended to quantify the 
pressure characteristics of the lower urinary tract. The system can be used to perform 
standard Urodynamic tests such as UF, CMG, UPP, and MS. 
The major application of Urodynamics is the diagnosis of uncontrolled loss of urine 
(incontinence), abnormal urinary retention, or neurological cases of Micturition disorder. 
The device is intended to be used as medical diagnostic equipment.   
Number of Subjects 
Up to 50 subjects will be enrolled.  Assuming a ~20% dropout rate, we expect 40 subjects 
(20 males and 20 females) to complete the study. 
Duration of Study and 
Follow-up 
Each subject will be in the study for up to 24 hours to complete ambulatory GUS. 
Study Population 
Patients with Lower Urinary Tract Dysfunction (LUTD) who are scheduled for cUDS 
studies. 
Study Site(s) 
Up to 6 sites in the United States 
Inclusion Criteria 
1.
Male or female patient must be ≥ 18 years of age
2.
Patient must have a diagnosis of LUTD
3.
Patient must be scheduled for or recommended for cUDS
4.
Patient is able to tolerate 18Fr catheterization
5.
Patient or patient’s legally authorized representative is able to provide informed
consent
Exclusion Criteria 
1.
Pregnant (as confirmed by urine pregnancy test) or breastfeeding, pregnant
within the past 6 months or intend to become pregnant during the study period.
2.
Patient has a symptomatic UTI based on CDC guidance (see below)
3.
Subjects who, at the principal investigator’s determination, would not be
appropriate for this study.
Experimental Procedures 
1.
Patient screened for eligibility and enrolled at the discretion of the principal
investigator.
2.
A urinalysis (if positive, urine culture), uroflowmetry, and post-void residual (PVR) will
be recorded prior to beginning the study.
3.
At the first clinic visit, a urine sample will be collected for urinalysis and urine culture
prior to any UDS procedures.

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4.
Patient is prepared for cUDS per standard of care
5.
Clinician will perform standard cUDS cystometry and pressure-flow studies per
standard of care including uroflowmetry and PVR.
6.
Upon completion of cUDS, the cUDS catheters are removed to allow for insertion of
the Glean Sensor.
7.
Clinician will gather GUS package and remove sterile pouch from outer packaging.
8.
Clinician will open the Glean Clinician App on the mobile device and initiate a new
patient Sensor Insertion. The tablet will prompt the clinician to scan the QR code of
the GUS.
9.
Clinician will scan the QR code through the transparent pouch of the packaging and
pair Sensor.
10. Once paired, the Clinician removes inner packaging from sterile pouch using aseptic
techniques and places it on a flat surface.
11. The Clinician prepares for aseptic insertion.
12. The Clinician instills lubricant into urethra. For patients with hypersensitivity to pain
and sensor insertion, a lubricant with a local anesthetic (e.g., lidocaine) can be
applied 5-10 minutes prior to cUDS catheter insertion.
13. Clinician applies lubricant to the Glean Sensor and the tip of the Glean Insertion
Sheath while still in the inner packaging.
14. Clinician draws the Sensor into insertion position within the Insertion Sheath by
pulling on the removal string from the proximal end of the Insertion Sheath. When
positioned correctly, the Sensor will protrude from the distal end of the Insertion
Sheath (no more than 1 cm).
15. The Clinician then uses the Insertion Sheath to place the Sensor in bladder.
16. The Clinician confirms Sensor’s placement and removes Insertion Sheath.
17. A removal string is taped to patient’s body (e.g., thigh, perineum).
18. Patient is asked to perform the following actions: sit up, stand, bend over, twist from
one side to the other, jump (if possible), squat (if possible), walk (if possible), cough,
and perform Valsalva maneuver (“bear down”).
19. The Patient is then trained to use the Patient Application.
20. In clinic ambulatory GUS is then collected. The patient can dress and leave the
procedure room. The patient is encouraged to drink fluids to fill their bladder and to
log bladder sensations using the Patient Application.
21. During this period, the patient will complete study surveys.
22. Upon logging sensation of a Strong Desire to Void (SDV), the patient will report back
to the clinical staff to void using the Uroflowmeter.
23. Clinician will use the clinician tablet to scan the QR code on the clinic uroflowmeter
and pair the clinic Uroflowmeter with the appropriate patient Sensor.
24. The patient will be instructed to void using the clinic Uroflowmeter and PVR will be
measured.
25. Upon completion of void, the Uroflowmeter will transfer data to the Clinician App and
data will be transferred to the Bright Uro servers.
26. The clinician will remove the Sensor by pulling on the removal string
27. The patient will then be discharged from the study.
Study Endpoints 
Baseline Characteristics and Demographics (obtained from EMR or patient chart):  Age, 
sex, prior urological conditions, reason for UDS, LUTD-related medications 
Primary Endpoints: Success of Glean sensor insertions and removals, subjects 
experiencing a device-related Serious Adverse Event (SAE), and subject exhibiting 
compliance in terms of device and voiding diary usage. 
Secondary Endpoints: Participant-reported outcomes (e.g., comfort, ease of use), 
successful transfer of GUS data from devices to clinician App and clinician web portal 
for clinician review. 
Analyses 
Success of Glean sensor insertions and removals will be calculated as percent of 
insertions and removals deemed successful by the clinician and subject.  

MUSE Study 
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Bright Uro - Proprietary and Confidential 
Safety will be reported as the percent of subjects experiencing a device-related SAE. 
Rates of SAEs will be calculated on a per-subject, per-event, or per-person-year of 
follow-up basis. Exact binomial confidence intervals will be calculated for subject-based 
or event-based rates. 
Likert scale outcomes will be summarized using frequencies and distributional statistics 
with binomial or normal approximation-based confidence intervals.  
Study and Data 
Management 
Bright Uro 
120 Vantis Drive, Suite 440 
Aliso Viejo, CA 92656 USA 
Telephone: 470.222.5323 
Fax: 949.998.4731 
clinical@brighturo.com  
Safety Monitoring 
Site Investigators