Trial for Reliability of Urodynamics SysTem

Inclusion criteria

• Female patient must be ≥ 18 years of age
• Patient is a candidate for urodynamics per standard of care
• Patient or patient's legally authorized representative is able to provide informed consent

Exclusion criteria

• Pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period
• Patient has one or more symptoms indicative of a urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and/or dysuria).
• Patient has history of recurrent UTIs (≥ 3 episodes in previous 12 months).
• Patient has used antibiotics within the past 7 days from the baseline/screening visit.
• Patient diagnosed with neurogenic LUTS (which may be associated with one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine).
• Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).
• Patient with a urostomy.
• 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).
• Patient who has from one or more major strictures in the urethra.
• 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 with a colostomy.
• Patient with any abnormal or concerning rectal or vaginal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, active yeast infections, or vaginitis.
• Patient has a known inability to void or is in complete retention.
• Subjects who, at the principal investigator's determination, would not be appropriate for this study