Clinical Feasibility Assessment of Glean Urodynamics System

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2025

Interventions

  • Device: Glean Urodynamics System
    • Wireless, catheter-free urodynamics system

Clinical Trial Outcome Measures

Primary Measures

  • Vesical pressure
    • Time Frame: during the procedure/surgery
    • Vesical pressure

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bright Uro
  • Collaborator
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Brittany Carter, 949.202.5685, brittany@brighturo.com

References

Frainey B, Majerus S, Derisavifard S, Williams AR, Balog BM, Butler RS, Goldman HB, Damaser MS. Safety, feasibility, and accuracy of the Uromonitor: a catheter-free, wireless ambulatory cystometry device. 35th EUS Annual Meeting, May 15, 2022, New Orleans, LA. Page 37.

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