Post-Approval Study of the Neuspera Sacral Neuromodulation System (NSM-005)

Neuspera Medical

Status: Enrolling

Conditions: Urinary Urgency Incontinence

Treatments: Device: Neuspera Implantable Sacral Neuromodulation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07144813

Neuspera Medical (NSM-005)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Neuspera Implantable Sacral Neuromodulation Stimulation System

Other group

Description:

Long term follow-up for the FDA approved Neuspera Sacral Neuromodulation Stimulation system

Treatment:

Device: Neuspera Implantable Sacral Neuromodulation System