RecruitingNot Applicable

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

United States72 participantsStarted 2026-03-31

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Range of vesical pressure (Pves)

Timeframe: Periprocedurally

Trial details

NCT IDNCT07485205

SponsorBright Uro

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Brittany Carter, DHSc, MPH

949-202-5689 brittany@brighturo.com

View on ClinicalTrials.gov More Lower Urinary Tract Symptoms (LUTS) trials