Recruiting

Neuspera SNM System

Sponsor:

Neuspera Medical, Inc.

Code:

NCT07144813

Conditions

Urinary Urgency Incontinence

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Neuspera Implantable Sacral Neuromodulation System

Study Details

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.

Conditions

Urinary Urgency Incontinence

Study ID

NCT07144813

Start date

Sep 3, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Design

Enrollment

116 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Neuspera Implantable Sacral Neuromodulation Stimulation System

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

Interventions

Neuspera Implantable Sacral Neuromodulation System

Stimulation of the Sacral Nerve.

Primary outcome measure

  • Primary Safety Endpoint [ Time Frame: Through 72 months ]
  • Primary Effectiveness Endpoint: [ Time Frame: Through 72 months ]

Central Contacts and Locations

Central contacts

Mark Vollmer

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

Shital Patel

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

Locations

Urology Austin,

Recruiting

Austin, Texas, United States, 78759

Contacts

Brian Mazzarella, MD

(502)-569-7904

Michelle Valentin-Rivera

(502)-569-7904

More Information

Sponsor

Neuspera Medical, Inc.

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • UUI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neuspera Medical, Inc. on 2026-02-04.