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Clinical Trials in the USA / NCT07485205
Recruiting Not applicable

Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults

NCT07485205 · tracked via the Priya Life Science USA tracker
Sponsor
Bright Uro
Phase
Not applicable
Started
2026-03-31
Last updated
2026-07-27

Condition(s) studied

Lower Urinary Tract Symptoms (LUTS)

Investigational drug(s) / intervention(s)

Glean Urodynamics System

Glean Urodynamics System: Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Healthy male and female adults ages 18 to 45 years. 2. Patient is able to read, write, and communicate in English. 3. Patient is able to provide informed consent. 4. Patient owns, can independently operate, and is willing to use a smart device for study data collection purposes Exclusion Criteria: 1. 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. 2. 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). 3. 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). 4. Patient has a known history of neurological conditions that can affect central nervous system function. 5. Patients with a current or prior diagnosis of diabetes mellitus (Type 1 or Type 2). 6. Patient is currently taking medications that may affect urological functions (e.g., diuretics, anticholinergics, alpha-blockers). 7. 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. 8. 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. 9. Patient has a urostomy and/or colostomy. 10. 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). 11. 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). 12. Patient would not be appropriate for this study as determined by the Principal Investigator.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Arizona Research Center Phoenix Arizona Recruiting
Del Sol Research Management Tucson Arizona Recruiting
Prestige Medical Group Tustin California Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07485205 on ClinicalTrials.gov ↗ ← All trials in the USA