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

Exclusion Criteria12

• 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.