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NCT07456865NARecruiting

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

MedtronicNeuro

Start Date

3/17/2026

Completion Date

11/1/2032

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Candidate for Altaviva™ therapy per Altaviva™ labeling 2. 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 3. 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 4. Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol 5. Willing and able to provide signed and dated informed consent Exclusion Criteria: 1. Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including: * Patients who are considered to be poor surgical candidates or who are at risk for poor wound healing per Altaviva™ labeling * Have progressive, systemic neurological disease * Have clinically significant peripheral neuropathy in the lower leg * Severe, uncontrolled diabetes 2. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment 3. Current symptomatic urinary tract infection 4. 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 5. Patients who have had treatment of urinary symptoms with botulinum toxin therapy or sacral neuromodulation in the past 6 months 6. History of a prior implantable tibial neuromodulation system 7. Patients who are pregnant or planning to become pregnant during the course of the study 8. Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound study results

Interventions

DEVICE

Altaviva™ system

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Conditions

Urge Urinary Incontinence

Locations

Urology Centers of Alabama

Homewood, Alabama 35209

United States

Rosemark Women Care Specialists

Idaho Falls, Idaho 83404

United States

Urology of Saint Louis

St Louis, Missouri 63141-8657

United States

Urology Specialists of the Carolinas

Greensboro, North Carolina 27403

United States

University Hospitals

Cleveland, Ohio 44106

United States

Central Ohio Urology Group

Gahanna, Ohio 43230

United States

Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania 18103

United States

Southern Urogynecology

West Columbia, South Carolina 29169-3456

United States

Urology Specialists

Sioux Falls, South Dakota 57108

United States

UPNT Research Institute

Arlington, Texas 76017

United States