RecruitingNot Applicable

Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device

United States256 participantsStarted 2026-03-17

Plain-language summary

The purpose of this prospective, multicenter study is to assess the long-term safety and effectiveness of the Altaviva™ system for the treatment of UUI

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Candidate for Altaviva™ therapy per Altaviva™ labeling
✓. Have a diagnosis of UUI as demonstrated on a 3-day voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
✓. If taking OAB medications, subjects should be on a stable dose for at least 3 months prior to baseline and willing to remain on stable treatment through completion of the 12-month voiding diary
✓. Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol
✓. Willing and able to provide signed and dated informed consent

Exclusion criteria

✕. Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including:
✕. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment
✕. Current symptomatic urinary tract infection
✕. Patients who have been treated with percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) therapy in the past 4 weeks, or longer if the investigator judges that the therapeutic effect is still present
✕. Patients who have had treatment of urinary symptoms with botulinum toxin therapy or sacral neuromodulation in the past 6 months
✕. History of a prior implantable tibial neuromodulation system
✕. Patients who are pregnant or planning to become pregnant during the course of the study
✕. Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound study results

What they're measuring

Primary Endpoint

Timeframe: 60 months

Trial details

NCT IDNCT07456865

SponsorMedtronicNeuro

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2032-11

Contact for this trial

Mylene Champs

763-526-1627 mylene.champs@medtronic.com

View on ClinicalTrials.gov More Urge Urinary Incontinence trials