Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
NCT07425015

Ambulatory Long Length URodynamics Evaluation

Led by Bright Uro · Updated on 2026-04-15

101

Participants Needed

7

Research Sites

67 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A prospective, open-label, single arm interventional trial evaluating the safety and performance of the in-clinic and extended monitoring of the lower urinary tract using the Glean Urodynamics System.

CONDITIONS

Official Title

Ambulatory Long Length URodynamics Evaluation

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patient must be 63 22 years of age.
  • Patient is a candidate for UDS per standard of care.
  • Patient is able to provide informed consent.
Not Eligible

You will not qualify if you...

  • Patient has symptoms of a urinary tract infection such as fever, pain, or worsening urinary symptoms.
  • Patient has had three or more urinary tract infections in the past 12 months.
  • Patient has used antibiotics within 7 days before baseline screening.
  • Patient diagnosed with neurogenic lower urinary tract dysfunction including conditions like cerebral palsy, spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, or dementia.
  • Patient diagnosed with interstitial cystitis, bladder pain syndrome, or chronic pelvic pain syndrome.
  • Patient has a urostomy or colostomy.
  • Patient has structural changes or previous surgery altering the lower urinary tract anatomy that may affect device placement.
  • Patient has Pelvic Organ Prolapse Quantification Grade III or higher.
  • Patient has abnormal rectal conditions such as anal fissures, fistulas, or active infections.
  • Patient has a known inability to urinate.
  • Patient has a history of radiation causing bleeding in the bladder.
  • Patient is pregnant, breastfeeding, recently pregnant within 6 months, or plans pregnancy during the study.
  • Patient may not be able to use a smart device independently.
  • Patients deemed inappropriate for the study by the principal investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Chesapeake Urology Associates

Hanover, Maryland, United States, 21076

Actively Recruiting

2

Chesapeake Urology Associates

Owings Mills, Maryland, United States, 21117

Actively Recruiting

3

Urology of St. Louis

St Louis, Missouri, United States, 63141

Actively Recruiting

4

MetroHealth

Cleveland, Ohio, United States, 44109

Actively Recruiting

5

Southern Urogynecology Wellness & Aesthetics

West Columbia, South Carolina, United States, 29169

Actively Recruiting

6

Sanford Health

Sioux Falls, South Dakota, United States, 57105

Actively Recruiting

7

Urology Partner of North Texas

Arlington, Texas, United States, 76017

Actively Recruiting

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Research Team

B

Brittany U Carter, DHSc, MPH

CONTACT

S

Suranjan Roychowdhury, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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