Clinical Feasibility Assessment of Glean Urodynamics System

March 7, 2024 updated by: Bright Uro

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult females patients with LUTS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vesical pressure
Time Frame: during the procedure/surgery
Vesical pressure
during the procedure/surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bright Uro

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0006
  • 1R44DK131700 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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