FREEDOM Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics

NCT07383688 | Not Yet Recruiting FDA Device

• 1 other identifier: Neuspera Medical (NSM-007)
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.

Conditions

Urinary Urge Incontinence

Outcome Measures

Primary Outcomes (1)

• Primary Study measure

  The changes to subject questionnaire responses for the Neuspera SNM system compared to responses regarding traditional SNM systems

  1 month

Study Arms (1)

Neuspera Replacement Cohort

Subjects with previous traditional SNM system and now undergoing implant of the Neuspera SNM System

Device: Neuspera Implantable Sacral Neuromodulation System

Interventions

Neuspera Implantable Sacral Neuromodulation System DEVICE

Stimulation of the Sacral Nerve

Neuspera Replacement Cohort

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population with 22 years of age or older and who have or have previously had a traditional SNM system.

You may qualify if:

• Currently have a traditional SNM device and has decided to have the device replaced with the Neuspera SNM System OR previously had an existing traditional SNM implant that was completely removed within the last year
• Is 22 years of age or older
• Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system
• Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling
• Is capable of participating in all testing and follow-up clinic visits associated with this clinical study.

You may not qualify if:

• Has a contraindication for the Neuspera SNM System per the device labeling.
• Has plans to enroll or is currently enrolled in another investigational device or drug trial during his/her participation in this study

Sponsors & Collaborators

• Neuspera Medical, Inc.: lead

Related Links

• Neuspera Medical web page

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kellen Choi, DO

  University of Louisville Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Vollmer

CONTACT

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

Shital Patel

CONTACT

3235281320; shital.patel@neuspera.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03