NCT07144813

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
44mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Sep 2025Dec 2029

First Submitted

Initial submission to the registry

August 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

September 3, 2025

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

August 25, 2025

Last Update Submit

February 2, 2026

Conditions

Urinary Urgency Incontinence

Keywords

UUI

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Neuspera Implantable Sacral Neuromodulation Stimulation System

OTHER

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

Device: Neuspera Implantable Sacral Neuromodulation System

Interventions

Neuspera Implantable Sacral Neuromodulation SystemDEVICE

Stimulation of the Sacral Nerve.

Neuspera Implantable Sacral Neuromodulation Stimulation System

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Kaiser Permanente Point Loma MOB

San Diego, California, 92110, United States

ACTIVE NOT RECRUITING

Genesis Healthcare Partners

San Diego, California, 92123, United States

ACTIVE NOT RECRUITING

Florida Urology Partners

Tampa, Florida, 33615, United States

ACTIVE NOT RECRUITING

Women's Health Advantage,

Fort Wayne, Indiana, 46825, United States

ACTIVE NOT RECRUITING

Indiana University, School of Medicine

Indianapolis, Indiana, 46202, United States

ACTIVE NOT RECRUITING

University of Kansas Medical Center,

Kansas City, Kansas, 66160, United States

ACTIVE NOT RECRUITING

University of Louisville Health System,

Louisville, Kentucky, 40202, United States

ACTIVE NOT RECRUITING

Ochsner Medical

New Orleans, Louisiana, 70121, United States

ACTIVE NOT RECRUITING

University of Michigan Health

Wyoming, Michigan, 49519, United States

ACTIVE NOT RECRUITING

Minnesota Urology

Woodbury, Minnesota, 55125, United States

ACTIVE NOT RECRUITING

Specialty Research of St. Louis

St Louis, Missouri, 63141, United States

ACTIVE NOT RECRUITING

Adult & Pediatric Urology P.C

Omaha, Nebraska, 68114, United States

ACTIVE NOT RECRUITING

Premier Medical Group,

Poughkeepsie, New York, 12603, United States

ACTIVE NOT RECRUITING

MetroHealth System,

Cleveland, Ohio, 44109, United States

ACTIVE NOT RECRUITING

Women's Healthcare Associates,

Portland, Oregon, 97225, United States

ACTIVE NOT RECRUITING

The Institute for Female Pelvic Medicine and Reconstructive Surgery,

North Wales, Pennsylvania, 19454, United States

ACTIVE NOT RECRUITING

Southern Urogynecology,

West Columbia, South Carolina, 29169, United States

ACTIVE NOT RECRUITING

Urology Austin,

Austin, Texas, 78759, United States

RECRUITING

UCNT Dallas,

Dallas, Texas, 75231, United States

ACTIVE NOT RECRUITING

Virginia Mason Medical Center,

Seattle, Washington, 98101, United States

ACTIVE NOT RECRUITING

Related Links

Study Officials

  • Osvaldo Padron, MD

    Florida Urology Partners

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Vollmer

CONTACT

408-433-3839mark.vollmer@neuspera.com

Shital Patel

CONTACT

323-528-1320shital.patel@neuspera.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

August 28, 2025

Study Start

September 3, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(20)