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

September 17, 2026 updated by: MedtronicNeuro

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Recruiting
    - Rosemark Women Care Specialists
    - Contact:
      
      Liz Carranza
      
      Phone Number: 208-557-2900
    - Principal Investigator:
      
      Ty Erickson
- Missouri
  - St Louis, Missouri, United States, 63141-8657
    - Recruiting
    - Urology of Saint Louis
    - Principal Investigator:
      
      Travis Bullock
    - Contact:
      
      Jackie King
      
      Phone Number: 314-567-6071
- North Carolina
  - Greensboro, North Carolina, United States, 27403
    - Recruiting
    - Urology Specialists of the Carolinas
    - Contact:
      
      Sherry Barnes
      
      Phone Number: 336-274-1114
    - Principal Investigator:
      
      Scott MacDiarmid
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Recruiting
    - TriHealth Hatton Research Institute
    - Contact:
      
      Jennifer Hodge
      
      Phone Number: 513-862-4012
    - Principal Investigator:
      
      Catrina Crisp
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - University Hospitals
    - Contact:
      
      Grace Moss
      
      Phone Number: 855-739-0679
    - Principal Investigator:
      
      Adonis Hijaz
  - Gahanna, Ohio, United States, 43230
    - Recruiting
    - Central Ohio Urology Group
    - Contact:
      
      Shayna Phillips
      
      Phone Number: 614-396-2684
    - Principal Investigator:
      
      Jeffrey Carey
- 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
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Penn Medicine Washington Square
    - Contact:
      
      Hanna Stambakio
      
      Phone Number: 215-316-5151
    - Principal Investigator:
      
      Ariana Smith
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina
    - Contact:
      
      Louisa Keil
      
      Phone Number: 843-792-5252
    - Principal Investigator:
      
      Eric Rovner
  - 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, 57105
    - Recruiting
    - Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic
    - Contact:
      
      Jennifer Pratt
      
      Phone Number: 605-328-8750
    - Principal Investigator:
      
      Kevin Benson
  - Sioux Falls, South Dakota, United States, 57108
    - Recruiting
    - Urology Specialists
    - Contact:
      
      Alexi Johnson
      
      Phone Number: 605-336-0635
    - Principal Investigator:
      
      Lauren Wood Thum
- Texas
  - Arlington, Texas, United States, 76017
    - Recruiting
    - UPNT Research Institute
    - Contact:
      
      Amanda Rosenberg
      
      Phone Number: 866-367-8768
    - Principal Investigator:
      
      Keith Xavier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 Time Frame: 60 months	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

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 17, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

MDT25016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.