Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
NCT07144813

Post-Approval Study of the Neuspera Sacral Neuromodulation System

Led by Neuspera Medical, Inc. · Updated on 2026-02-04

116

Participants Needed

20

Research Sites

221 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Post-Approval Study of the Neuspera Sacral Neuromodulation System

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects in the SANS-UUI Phase I or Phase II study
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 20 locations

1

Kaiser Permanente Point Loma MOB

San Diego, California, United States, 92110

Active, Not Recruiting

2

Genesis Healthcare Partners

San Diego, California, United States, 92123

Active, Not Recruiting

3

Florida Urology Partners

Tampa, Florida, United States, 33615

Active, Not Recruiting

4

Women's Health Advantage,

Fort Wayne, Indiana, United States, 46825

Active, Not Recruiting

5

Indiana University, School of Medicine

Indianapolis, Indiana, United States, 46202

Active, Not Recruiting

6

University of Kansas Medical Center,

Kansas City, Kansas, United States, 66160

Active, Not Recruiting

7

University of Louisville Health System,

Louisville, Kentucky, United States, 40202

Active, Not Recruiting

8

Ochsner Medical

New Orleans, Louisiana, United States, 70121

Active, Not Recruiting

9

University of Michigan Health

Wyoming, Michigan, United States, 49519

Active, Not Recruiting

10

Minnesota Urology

Woodbury, Minnesota, United States, 55125

Active, Not Recruiting

11

Specialty Research of St. Louis

St Louis, Missouri, United States, 63141

Active, Not Recruiting

12

Adult & Pediatric Urology P.C

Omaha, Nebraska, United States, 68114

Active, Not Recruiting

13

Premier Medical Group,

Poughkeepsie, New York, United States, 12603

Active, Not Recruiting

14

MetroHealth System,

Cleveland, Ohio, United States, 44109

Active, Not Recruiting

15

Women's Healthcare Associates,

Portland, Oregon, United States, 97225

Active, Not Recruiting

16

The Institute for Female Pelvic Medicine and Reconstructive Surgery,

North Wales, Pennsylvania, United States, 19454

Active, Not Recruiting

17

Southern Urogynecology,

West Columbia, South Carolina, United States, 29169

Active, Not Recruiting

18

Urology Austin,

Austin, Texas, United States, 78759

Actively Recruiting

19

UCNT Dallas,

Dallas, Texas, United States, 75231

Active, Not Recruiting

20

Virginia Mason Medical Center,

Seattle, Washington, United States, 98101

Active, Not Recruiting

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Research Team

M

Mark Vollmer

CONTACT

S

Shital Patel

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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