Actively Recruiting
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
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, open-label, single arm interventional trial to establish normative reference ranges for urodynamics parameters in healthy adult participants using using the Glean Urodynamics System.
CONDITIONS
Official Title
Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults
Who Can Participate
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, can operate independently, and is willing to use a smart device for study data collection.
You will not qualify if you...
- Any prior pregnancy, current pregnancy, or intent to become pregnant during the study.
- Symptoms of urinary tract infection such as fever, costovertebral angle pain, suprapubic tenderness, worsening urinary frequency, urgency, or dysuria.
- History of urological conditions like recurrent UTIs, incontinence, BPH, neurogenic bladder, interstitial cystitis, urinary retention, or genitourinary cancer.
- History of neurological conditions affecting central nervous system function.
- Current or prior diagnosis of diabetes mellitus (Type 1 or Type 2).
- Taking medications affecting urological function (e.g., diuretics, anticholinergics, alpha-blockers).
- Abnormal urinary habits as reported on a 3-day bladder diary (urinary frequency ≥8 times/day, ≥1 nocturia episode, ≥1 leak event, or ≥1 urgency event).
- Total score on LURN SI-10 questionnaire greater than 0 except for urinary frequency of 4-7 times per day.
- Presence of urostomy and/or colostomy.
- Atypical anatomic structural variation or previous surgery changing lower urinary tract anatomy that may affect device 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
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
Research Team
B
Brittany 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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