Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults
1 other identifier
interventional
72
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2026
CompletedFirst Posted
Study publicly available on registry
March 20, 2026
CompletedStudy Start
First participant enrolled
March 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 22, 2026
April 1, 2026
11 months
March 12, 2026
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Range of vesical pressure (Pves)
Range of vesical pressure (Pves) in cm H2O as measured by the Glean Bladder Sensor
Periprocedurally
Study Arms (1)
Glean Urodynamics System
EXPERIMENTALGlean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.
Interventions
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.
Eligibility Criteria
You may qualify if:
- Healthy male and female adults ages 18 to 45 years.
- Patient is able to read, write, and communicate in English.
- Patient is able to provide informed consent.
- Patient owns, can independently operate, and is willing to use a smart device for study data collection purposes
You may not qualify if:
- Patient with any prior pregnancy (gravida ≥1), is currently pregnant (as confirmed by urine pregnancy test or medical history), or intends to become pregnant during the study period.
- Patient has one or more symptoms indicative of a symptomatic urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and/or dysuria).
- Patient has a known history of urological conditions (e.g., recurrent UTIs, incontinence, symptomatic benign prostatic hyperplasia, neurogenic bladder, interstitial cystitis, urinary retention, any genitourinary cancer).
- Patient has a known history of neurological conditions that can affect central nervous system function.
- Patients with a current or prior diagnosis of diabetes mellitus (Type 1 or Type 2).
- Patient is currently taking medications that may affect urological functions (e.g., diuretics, anticholinergics, alpha-blockers).
- Patient has abnormal urinary habits if one or more of the following bladder events are reported on any day of the 3-day bladder diary: urinary frequency ≥ 8 times/day, ≥ 1 nocturia episode, ≥ 1 leak event, or ≥ 1 urgency event.
- Patient has a total score on the Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10) questionnaire greater than 0; a total score of 1 is acceptable only if the sole positive response is urinary frequency of 4-7 times per day.
- Patient has a urostomy and/or colostomy.
- 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) that the principal investigator deems might compromise the placement or retention of the Glean sensors during the study (e.g., strictures).
- 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).
- Patient would not be appropriate for this study as determined by the Principal Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bright Urolead
Study Sites (3)
Arizona Research Center
Phoenix, Arizona, 85053, United States
Del Sol Research Management
Tucson, Arizona, 85715, United States
Boulder Medical Center
Boulder, Colorado, 80304, United States
Related Publications (1)
Kim J, Xavier K, Cannon-Smith T, Vaughan T, Vemulapalli S, Zhao H, Aalami-Harandi A, Shah N. The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study. J Endourol. 2025 Jun;39(6):625-634. doi: 10.1089/end.2025.0270. Epub 2025 May 2.
PMID: 40314068BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brittany Carter
Bright Uro
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2026
First Posted
March 20, 2026
Study Start
March 31, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Proprietary data