A Study of the PedSCath Pediatric Sampling Catheter Versus Current Standard of Care.
A Study of the PedSCath Pediatric Sampling Catheter Versus Current Standard of Care.
This is a retrospectively-controlled clinical trial that will examine the rate of positive
 UTI cases among pediatrics entered into the Emergency Department and whose urine is withdrawn
 using the PedSCath Pediatric Sampling Catheter. The rate of postive UTI will be compared
 against the control population, whose urine withdrawal would have been performed with
 Standard of Care devices.
This will be a multi-center, retrospective-controlled, clinical trial.

 Anonymized retrospective data from two clinical sites, NewYork-Presbyterian Queens and Weill
 Cornell Medical College, from 2016 and 2018 will be used to define the control subject
 population, who were assessed for urinary tract infection (UTI) based on a urine sample taken
 according to Standard of Care (SoC).

 Subjects entering the emergency department (ED) generally require that a urine specimen is
 obtained and tested to determine whether there is an active infection in the bladder.
 Emergency department personnel will confirm the possibility of UTI based on symptoms and
 inform the parents/guardians of the potential for study participation using the PedSCath. The
 physician will assess the subject based on Inclusion and Exclusion criteria, including
 non-toilet training and an upper age limit of 3 years. If determined that the subject meets
 inclusion/exclusion criteria, the physician will inform the parents/guardians of the subject
 about the study and request informed consent if the parents/guardians wish their child to
 participate.

 Following the granting of Informed Consent, subjects will be enrolled in the study within the
 treatment arm and a urine sample of 2-3 ml will be taken via the PedSCath. All study
 assessments, from enrollment through urine sample collection, will occur over a single visit
 to the ED. Per standard of care, any treatment following the diagnosis will be performed by
 hospital staff based on physician assessment. Up to 3 run-in subjects per PedSCath user will
 be treated with PedSCath to allow PedSCath users to become familiar with PedSCath mechanism.
Inclusion Criteria:

 -  Subject is 3 years of age or younger.

 -  Subject is non-toilet trained, as communicated by subject's parent/guardian.

 -  Subject is presenting to the emergency department with symptoms for UTI, as described
 by AAP guidelines (Newborns with UTI may present with jaundice, sepsis, failure to
 thrive, vomiting, or fever. In infants and young children, typical signs and symptoms
 include fever, strong-smelling urine, hematuria, abdominal or flank pain, and
 new-onset urinary incontinence) or as determined by PI.

 -  Subject's parent/guardian is able to provide informed consent.

 Exclusion Criteria:

 -  Any subject with known underlying abnormalities to the genitourinary tract (e.g.
 prenatal hydronephrosis).

 -  Any subject who has had prior genitourinary tract or abdominal surgery.

 -  Any subject who is toilet trained (i.e. able to provide a clean catch urine sample).

 -  Any subject with an active rash or skin lesion in the suprapubic area.

 -  Any subject with a known allergy to LDPE, Elvax, or Crodamide plastics.