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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuspera Implantable Sacral Neuromodulation Stimulation System | Other | Long term follow-up for the FDA approved Neuspera Sacral Neuromodulation Stimulation system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuspera Implantable Sacral Neuromodulation System | Device | Stimulation of the Sacral Nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Incidence of device- and procedure-related AEs | Through 72 months |
| Primary Effectiveness Endpoint: | Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more | Through 72 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Vollmer | Contact | 408-433-3839 | mark.vollmer@neuspera.com | |
| Shital Patel | Contact | 323-528-1320 | shital.patel@neuspera.com |
| Name | Affiliation | Role |
|---|---|---|
| Osvaldo Padron, MD | Florida Urology Partners | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Point Loma MOB | Active, not recruiting | San Diego | California | 92110 | United States | |
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| Label | URL |
|---|---|
| Neuspera Medical web page | View source |
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| Genesis Healthcare Partners |
| Active, not recruiting |
| San Diego |
| California |
| 92123 |
| United States |
| Florida Urology Partners | Active, not recruiting | Tampa | Florida | 33615 | United States |
| Women's Health Advantage, | Active, not recruiting | Fort Wayne | Indiana | 46825 | United States |
| Indiana University, School of Medicine | Active, not recruiting | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center, | Active, not recruiting | Kansas City | Kansas | 66160 | United States |
| University of Louisville Health System, | Active, not recruiting | Louisville | Kentucky | 40202 | United States |
| Ochsner Medical | Active, not recruiting | New Orleans | Louisiana | 70121 | United States |
| University of Michigan Health | Active, not recruiting | Wyoming | Michigan | 49519 | United States |
| Minnesota Urology | Active, not recruiting | Woodbury | Minnesota | 55125 | United States |
| Specialty Research of St. Louis | Active, not recruiting | St Louis | Missouri | 63141 | United States |
| Adult & Pediatric Urology P.C | Active, not recruiting | Omaha | Nebraska | 68114 | United States |
| Premier Medical Group, | Active, not recruiting | Poughkeepsie | New York | 12603 | United States |
| MetroHealth System, | Active, not recruiting | Cleveland | Ohio | 44109 | United States |
| Women's Healthcare Associates, | Active, not recruiting | Portland | Oregon | 97225 | United States |
| The Institute for Female Pelvic Medicine and Reconstructive Surgery, | Active, not recruiting | North Wales | Pennsylvania | 19454 | United States |
| Southern Urogynecology, | Active, not recruiting | West Columbia | South Carolina | 29169 | United States |
| Urology Austin, | Recruiting | Austin | Texas | 78759 | United States |
|
| UCNT Dallas, | Active, not recruiting | Dallas | Texas | 75231 | United States |
| Virginia Mason Medical Center, | Active, not recruiting | Seattle | Washington | 98101 | United States |