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

Recruiting now · Not applicable

Conditions studied: Urge Urinary Incontinence

In brief

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

Key facts

Study ID

NCT07456865

Run by

MedtronicNeuro

People needed

256

Starts

2026-03-17

Expected to finish

2032-11-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Urology Centers of Alabama — Homewood, Alabama, United States (enrolling)
• Rosemark Women Care Specialists — Idaho Falls, Idaho, United States (enrolling)
• Urology of Saint Louis — St Louis, Missouri, United States (enrolling)
• Urology Specialists of the Carolinas — Greensboro, North Carolina, United States (enrolling)
• University Hospitals — Cleveland, Ohio, United States (enrolling)
• Central Ohio Urology Group — Gahanna, Ohio, United States (enrolling)
• Institute for Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States (enrolling)
• Southern Urogynecology — West Columbia, South Carolina, United States (enrolling)
• Urology Specialists — Sioux Falls, South Dakota, United States (enrolling)
• UPNT Research Institute — Arlington, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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