Clinical Feasibility Assessment of Glean Urodynamics System

Sponsor

Bright Uro (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05694793

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this prospective observational trial is to assess the safety and reliability of the Glean Urodynamics System (GUS) in adult females with lower urinary tract symptoms. The main question[s] it aims to answer are:

• What is GUS's ability to safely and reliably conduct wireless, catheter-free monitoring of vesical pressure compared to the vesical pressures collected with conventional urodynamics?

Participants will undergo a conventional urodynamics exam, a simultaneous urodynamics exam with GUS, ambulatory urodynamics with GUS, and extended home monitoring with GUS.

Researchers will compare GUS data with that from a conventional urodynamics exam.

Condition or Disease	Intervention/Treatment	Phase
Urologic Diseases Urodynamics	Device: Glean Urodynamics System

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of Clinical Feasibility and Safety of Wireless, Catheter-Free Glean Urodynamics System (GUS) in Adult Females With Lower Urinary Tract Symptoms (LUTS)

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Outcome Measures

Primary Outcome Measures

Vesical pressure [during the procedure/surgery]
Vesical pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female patients ages 18 years or older with a diagnosis of LUTS
Scheduled for or recommended for conventional urodynamics
Able to tolerate 18 Fr catheterization
Able to provide informed consent

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
Has an active and symptomatic UTI (positive urine culture), or patient has an active and asymptomatic UTI (positive urine culture) and is not being treated prophylactically
Diagnosed with neurogenic LUTD (i.e., known history of traumatic spinal cord injury, Parkinson's disease, multiple sclerosis, traumatic brain injury, or spina bifida)
Has an atypical anatomic structural variation or has had a previous surgical intervention that has permanently changed structural anatomy anywhere along their lower urinary tract (urethra, pelvic floor, urethral sphincter, and/or bladder wall).
Has a known inability to void or is in complete retention
Who, at the principal investigator's determination, would not be appropriate for this study