Long-term follow-up of the Neuspera sacral neuromodulation system for urinary urgency incontinence.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm post-approval follow-up of subjects previously implanted with the Neuspera sacral neuromodulation system during the Phase I or Phase II SANS-UUI studies. Enrolled participants will have scheduled visits out to 72 months post-implant to collect safety data, device performance metrics, and patient-reported urinary outcomes. The protocol focuses on long-term adverse events, device-related complications, and durability of symptom improvement. Results will fulfill the FDA post-approval study requirement and inform long-term use of the device.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects in the SANS-UUI Phase I or Phase II study

Exclusion Criteria:

* None

Where it's running

• Urology Austin,
  Austin, Texas, United States Recruiting
• Kaiser Permanente Point Loma MOB
  San Diego, California, United States Active not recruiting
• Genesis Healthcare Partners
  San Diego, California, United States Active not recruiting
• Florida Urology Partners
  Tampa, Florida, United States Active not recruiting
• Women's Health Advantage,
  Fort Wayne, Indiana, United States Active not recruiting
• Indiana University, School of Medicine
  Indianapolis, Indiana, United States Active not recruiting

Study contacts

• Principal investigator: Osvaldo Padron, MD — Florida Urology Partners
• Study coordinator: Mark Vollmer
• Email: mark.vollmer@neuspera.com
• Phone: 408-433-3839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.