Overview
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations
Description
The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.
Eligibility
Inclusion Criteria:
- Patients medically indicated for urodynamic study
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Exclusion Criteria:
- 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
- Requires use of suprapubic catheter