NCT07144813

Post-Approval Study of the Neuspera Sacral Neuromodulation System

Clinical Post- Approval Study of the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Neuspera Medical, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, single-arm, post-approval study is designed to assess the long-term safety and efficacy data of the Neuspera Sacral Neuromodulation (SNM) System following commercial approval of the Neuspera SNM System. Participants in this study received intervention/implanted in Phase I or Phase II of the Neuspera SANS\_UUI (NSM-004) Study.

Detailed description

The Neuspera SNM System received FDA PMA approval for the treatment of urinary urge incontinence in subjects who have failed, could not tolerate, or were not a candidate for more conservative treatment. The study will serve as the Post Approval Study (PAS) requirement of the PMA Approval. This post approval study (PAS) is designed to assess the long-term safety and effectiveness data out to 72 months post-implant, in consenting subjects implanted in Phase I or Phase II study.

Conditions

• Urinary Urgency Incontinence

Interventions

Type	Name	Description
DEVICE	Neuspera Implantable Sacral Neuromodulation System	Stimulation of the Sacral Nerve.

Timeline

• Start date: 2025-09-03
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2025-08-28
• Last updated: 2026-02-04

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study