RecruitingNot ApplicableNCT07456865

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

Sponsor

MedtronicNeuro

Enrollment

256 participants

Start Date

Mar 17, 2026

Study Type

INTERVENTIONAL

Conditions

Urge Urinary Incontinence

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria12

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