Actively Recruiting
Trial for Reliability of Urodynamics SysTem
Led by Bright Uro · Updated on 2026-04-23
28
Participants Needed
4
Research Sites
56 weeks
Total Duration
On this page
Sponsors
B
Bright Uro
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial for Reliability of Urodynamics SysTem
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patient must be �3E= 18 years of age
- Patient is a candidate for urodynamics per standard of care
- Patient or patient's legally authorized representative is able to provide informed consent
You will not qualify if you...
- Pregnant or breastfeeding, pregnant within the past 6 months, or intend to become pregnant during the study period
- Symptoms of a urinary tract infection such as fever, pain, or worsening urinary symptoms
- History of recurrent urinary tract infections (3 or more episodes in the past 12 months)
- Use of antibiotics within 7 days before the baseline or screening visit
- Diagnosis of neurogenic lower urinary tract symptoms related to specific neurological conditions
- Diagnosis of interstitial cystitis, bladder pain syndrome, painful bladder syndrome, or chronic pelvic pain syndrome
- Presence of a urostomy
- Structural changes or surgery permanently altering the lower urinary tract anatomy
- Presence of one or more major strictures in the urethra
- Pelvic organ prolapse grade III or higher
- Presence of a colostomy
- Abnormal or concerning rectal or vaginal conditions such as anal fissures, fistula, active infections, or vaginitis
- Known inability to void or complete urinary retention
- Any other condition making the patient inappropriate for the study as determined by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Tri Valley Urology Medical Group
Murrieta, California, United States, 92562
Actively Recruiting
2
University of California San Diego
San Diego, California, United States, 92121
Completed
3
Unio Health Partners
Torrence, California, United States, 90503
Withdrawn
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Completed
Research Team
B
Brittany Carter, DHSc
CONTACT
S
Suranjan Roychowdhury, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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