The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study.
Jason Kim, Keith Xavier, Tracy Cannon-Smith...
https://pubmed.ncbi.nlm.nih.gov/40314068Actively Recruiting
Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID07485205
Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults
Led by Bright Uro · Updated on 2026-04-22
72
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the normal ranges of urodynamics parameters using the Glean Urodynamics System in healthy adults aged 18 to 45 years. This open-label, single-arm interventional trial aims to gather reference data for bladder and abdominal pressure measurements to better understand lower urinary tract function in people without urinary symptoms. Participants will have the Glean Urodynamics System placed, which includes a bladder pressure sensor, abdominal pressure sensor, an in-clinic uroflowmeter, and software apps. The device will be used for ambulatory monitoring in the clinic, then participants will continue monitoring with the sensor in place outside the clinic for up to 24 hours. The sensor will be removed within 24 hours following insertion. During the study, participants will undergo monitoring of vesical pressure and other urodynamics parameters. They will receive a follow-up phone call seven days after sensor removal to assess any issues. The primary outcome measured is the range of vesical pressure during the procedure. The total study participation includes the in-clinic monitoring, up to 24 hours of ambulatory monitoring, and follow-up contact.
CONDITIONS
Brief Title
Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults
Who Can Participate
Age: 18Years - 45Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy male and female adults ages 18 to 45 years
- Able to read, write, and communicate in English
- Able to provide informed consent
- Owns and can independently operate a smart device for study data collection
You will not qualify if you...
- Prior pregnancy, current pregnancy, or plans to become pregnant during the study
- Symptoms of urinary tract infection such as fever, pain, urgency, or frequency
- History of urological conditions including recurrent UTIs, incontinence, benign prostatic hyperplasia, neurogenic bladder, interstitial cystitis, retention, or genitourinary cancer
- History of neurological conditions affecting central nervous system function
- Current or prior diagnosis of diabetes mellitus
- Taking medications that affect urological function such as diuretics or anticholinergics
- Abnormal urinary habits as recorded in a 3-day bladder diary
- LURN SI-10 symptom index score greater than 0 except for mild urinary frequency
- Presence of urostomy or colostomy
- Anatomical variations or surgeries altering lower urinary tract anatomy that affect sensor placement
- Pelvic Organ Prolapse Quantification Grade III or higher
- Deemed inappropriate for the study by the Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Up to 24 hours
Participants have the Glean Urodynamics System inserted for an in-clinic ambulatory monitoring period.
1 in-clinic visit for sensor insertion and monitoring
Long-term Monitoring
Duration - Up to 24 hours
Participants are discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, not exceeding 24 hours, followed by sensor removal.
Monitoring outside the clinic for up to 24 hours
Follow-up
Duration - 1 day
Participants receive a follow-up phone call 7 days after sensor removal to check on their status.
1 phone call follow-up
Trial Site Locations
Total: 3 locations
1
Arizona Research Center
Phoenix, Arizona, United States, 85053
Actively Recruiting
2
Del Sol Research Management
Tucson, Arizona, United States, 85715
Actively Recruiting
3
Boulder Medical Center
Boulder, Colorado, United States, 80304
Not Yet Recruiting
Loading map...
Research Team
B
Brittany Carter, DHSc, MPH
S
Suranjan Roychowdhury, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here