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
6
Treatment groupsSee each treatment group below.
Laborie Medical Technologies Inc.
Lead sponsor