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

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

Study Overview

• Status: Recruiting
• Conditions: Urge Urinary Incontinence
• Intervention / Treatment: Device: Altaviva™ system

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mylene Champs; Phone Number: 763-526-1627; Email: mylene.champs@medtronic.com

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Recruiting
      • Urology Centers Of Alabama
      • Contact: Kaitlin Williams; Phone Number: 205-930-0920
      • Principal Investigator: Alison Pickering
  • Missouri
    • St Louis, Missouri, United States, 63141-8657
      • Recruiting
      • Urology of Saint Louis
      • Contact: Mejra Dzinic; Phone Number: 314-567-6071
      • Principal Investigator: Travis Bullock
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Recruiting
      • Institute for Female Pelvic Medicine and Reconstructive Surgery
      • Principal Investigator: Vincent Lucente
      • Contact: Eileen Taff; Phone Number: 610-402-1800
  • South Carolina
    • West Columbia, South Carolina, United States, 29169-3456
      • Recruiting
      • Southern Urogynecology
      • Contact: Tina McGready; Phone Number: 803-457-7000
      • Principal Investigator: Jessica Rueb
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Recruiting
      • Urology Specialists
      • Contact: Alexi Johnson; Phone Number: 605-336-0635
      • Principal Investigator: Lauren Wood Thum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MedtronicNeuro

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Urge
• Other Study ID Numbers: MDT25016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes