Post-Market Follow-up Study of the NXT Urodynamics System Evaluating Safety and Performance in Patients Needing Urodynamic Testing

What this Trial Is About

This research aims to confirm the ongoing safety and performance of the NXT Urodynamics System in patients who require urodynamic studies for various urinary conditions. It focuses on patient groups including pediatric patients, adults with urinary incontinence or obstruction, overactive bladder, and those with neurological co-morbidities. The study is observational and evaluates the system in real-world clinical settings. Participants undergo the NXT urodynamic procedure, a diagnostic test used to assess bladder and urinary function. The study includes several patient sub-populations such as pediatric patients, male and female adults with obstructive or incontinence conditions, and adults with neurological issues. The study tracks the systems performance and safety during these procedures. During the study, researchers assess the performance and safety of the NXT system within a 120-minute evaluation period. Participants are monitored for any complications or issues related to the diagnostic procedure. The study involves patient questionnaires and informed consent processes to ensure accurate communication and data collection, with follow-up and data analysis continuing until March 2027.

NXT Post-Market Clinical Follow-up