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 range22 Years

SexALL

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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

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