NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations
Patients medically indicated for urodynamic study
Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire
Patients with confirmed active bladder infections (not including patients with asymptotic bacteria)
Pregnant women
Patients with recent (less than 2 weeks) pelvic floor surgery
Male, Female and Pediatric subjects who have been medically indicated for UDS testing.
Cohort
Prospective
Urodynamic procedure
Diagnostic testUrodynamic procedure
6
Treatment groupsSee each treatment group below.
Assess NXT system performance
Assess the proportion of affirmative responses to the question: did the NXT system successfully measure all necessary urodynamic parameters you required for this patient?
Assess NXT system safety
The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.
Assess NXT system performance
Assess the proportion of affirmative responses to the question: Was the urodynamic study completed without any technical failure that prevented its completion?
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