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.
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
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.
Single group
Glean Urodynamics System
DeviceGlean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.
Range of vesical pressure (Pves)
Range of vesical pressure (Pves) in cm H2O as measured by the Glean Bladder Sensor
