Modern Urodynamics System Efficacy (MUSE) Study

Modern Urodynamics System Efficacy (MUSE) Study

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.

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:

• 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.