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

NCT07456865 | Recruiting FDA Device

• 1 other identifier: MDT25016
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Urge Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The primary endpoint is the UUI responder rate, which is defined as the proportion of subjects experiencing at least 50% improvement in daily UUI compared to baseline. The UUI responder rate will be measured annually through 60 months.

  60 months

Interventions

Altaviva™ system DEVICE

Programmable neurostimulation system that delivers electrical stimulation to the tibial nerve for tibial neuromodulation therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (1)

Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mylene Champs

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 9, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)