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NCT05694793 | Not yet recruiting | Urologic Diseases

Clinical Feasibility Assessment of Glean Urodynamics System
Sponsor:

Bright Uro

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

Urologic Diseases

Urodynamics

Intervention/treatment

Glean Urodynamics System

Study Type : Observational
Estimated Enrollment : 50 participants
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)
Actual Study Start Date : June 2024
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
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
Clinical Feasibility Assessment of Glean Urodynamics System

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Clinical Feasibility Assessment of Glean Urodynamics System

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