Long-Term Safety and Effectiveness Study of the Neuspera Sacral Neuromodulation System for Urinary Urgency Incontinence

What this Trial Is About

This research aims to evaluate the long-term safety and effectiveness of the Neuspera Sacral Neuromodulation SNM System in people with urinary urgency incontinence who have previously participated in earlier phases of the Neuspera SANSUUI study. The system has received FDA approval for patients who have not responded to more conservative treatments or cannot tolerate them. This study fulfills the post-approval requirements to monitor the devices performance over time. Participants in this study have already received the Neuspera SNM System implant during Phase I or Phase II of the prior study. The focus is on observing the devices effects and safety up to 72 months after implantation. No new treatments or placebo groups are involved, as this is a single-arm follow-up study of the approved device. During the study, participants will have regular follow-up visits to assess safety and effectiveness outcomes for up to six years after implantation. Researchers will monitor participants urinary symptoms and any device-related issues over time. The study is designed to collect comprehensive long-term data to better understand the devices ongoing impact and safety in real-world use.

Post-Approval Study of the Neuspera Sacral Neuromodulation System