Not Yet RecruitingNot Applicable

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

100 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Study measure

Timeframe: 1 month

Trial details

NCT IDNCT07383688

SponsorNeuspera Medical, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10

Contact for this trial

Mark Vollmer

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

View on ClinicalTrials.gov More Urinary Urge Incontinence trials