RECRUITING

Trial for Reliability of Urodynamics SysTem

Conditions

Urologic Diseases Urodynamics Lower Urinary Tract Dysfunction Urinary Incontinence Overactive Bladder Home Monitoring Uroflowmetry

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this prospective 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.

Official Title

Trial for Reliability of Urodynamics SysTem

Quick Facts

Study Start:2025-06-03

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05694793

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Female patient must be ≥ 18 years of age 2. Patient is a candidate for urodynamics per standard of care 3. Patient or patient's legally authorized representative is able to provide informed consent	1. Pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period 2. Patient has one or more symptoms indicative of a urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and/or dysuria). 3. Patient has history of recurrent UTIs (≥ 3 episodes in previous 12 months). 4. Patient has used antibiotics within the past 7 days from the baseline/screening visit. 5. Patient diagnosed with neurogenic LUTS (which may be associated with one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine). 6. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS). 7. Patient with a urostomy. 8. Patient 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). 9. Patient who has from one or more major strictures in the urethra. 10. Patient has a Pelvic Organ Prolapse Quantification (POP-Q) of Grade III or higher (i.e., most distal portion of the prolapse protrudes more than 1 centimeter below the hymen). 11. Patient with a colostomy. 12. Patient with any abnormal or concerning rectal or vaginal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, active yeast infections, or vaginitis. 13. Patient has a known inability to void or is in complete retention. 14. Subjects who, at the principal investigator's determination, would not be appropriate for this study

Inclusion Criteria

Exclusion Criteria

1. Female patient must be ≥ 18 years of age
2. Patient is a candidate for urodynamics per standard of care
3. Patient or patient's legally authorized representative is able to provide informed consent

1. Pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period
2. Patient has one or more symptoms indicative of a urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and/or dysuria).
3. Patient has history of recurrent UTIs (≥ 3 episodes in previous 12 months).
4. Patient has used antibiotics within the past 7 days from the baseline/screening visit.
5. Patient diagnosed with neurogenic LUTS (which may be associated with one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine).
6. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).
7. Patient with a urostomy.
8. Patient 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).
9. Patient who has from one or more major strictures in the urethra.
10. Patient has a Pelvic Organ Prolapse Quantification (POP-Q) of Grade III or higher (i.e., most distal portion of the prolapse protrudes more than 1 centimeter below the hymen).
11. Patient with a colostomy.
12. Patient with any abnormal or concerning rectal or vaginal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, active yeast infections, or vaginitis.
13. Patient has a known inability to void or is in complete retention.
14. Subjects who, at the principal investigator's determination, would not be appropriate for this study

Contacts and Locations

Study Contact

Brittany Carter, DHSc

CONTACT

949.202.5685

brittany@brighturo.com

Suranjan Roychowdhury, PhD

CONTACT

949.202.5685

suranjan@brighturo.com

Study Locations (Sites)

Tri Valley Urology Medical Group

Murrieta, California, 92562

United States

University of California San Diego

San Diego, California, 92121

United States

Unio Health Partners

Torrence, California, 90503

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Bright Uro

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 Registration Dates

Study Start Date2025-06-03

Study Completion Date2025-07

Study Record Updates

Study Start Date2025-06-03

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

Lower Urinary Tract Dysfunction
Urinary Incontinence
Overactive Bladder
Home Monitoring
Urodynamics
Uroflowmetry

Additional Relevant MeSH Terms

Urologic Diseases
Urodynamics