RecruitingNot ApplicableNCT07144813

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)


Sponsor

Neuspera Medical, Inc.

Enrollment

116 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 Years

Inclusion Criteria1

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

Exclusion Criteria1

  • None

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Interventions

DEVICENeuspera Implantable Sacral Neuromodulation System

Stimulation of the Sacral Nerve.


Locations(20)

Kaiser Permanente Point Loma MOB

San Diego, California, United States

Genesis Healthcare Partners

San Diego, California, United States

Florida Urology Partners

Tampa, Florida, United States

Women's Health Advantage,

Fort Wayne, Indiana, United States

Indiana University, School of Medicine

Indianapolis, Indiana, United States

University of Kansas Medical Center,

Kansas City, Kansas, United States

University of Louisville Health System,

Louisville, Kentucky, United States

Ochsner Medical

New Orleans, Louisiana, United States

University of Michigan Health

Wyoming, Michigan, United States

Minnesota Urology

Woodbury, Minnesota, United States

Specialty Research of St. Louis

St Louis, Missouri, United States

Adult & Pediatric Urology P.C

Omaha, Nebraska, United States

Premier Medical Group,

Poughkeepsie, New York, United States

MetroHealth System,

Cleveland, Ohio, United States

Women's Healthcare Associates,

Portland, Oregon, United States

The Institute for Female Pelvic Medicine and Reconstructive Surgery,

North Wales, Pennsylvania, United States

Southern Urogynecology,

West Columbia, South Carolina, United States

Urology Austin,

Austin, Texas, United States

UCNT Dallas,

Dallas, Texas, United States

Virginia Mason Medical Center,

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07144813


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