Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)
TITAN 2
1 other identifier
interventional
188
1 country
29
Brief Summary
The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2022
CompletedStudy Start
First participant enrolled
January 31, 2022
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedResults Posted
Study results publicly available
November 21, 2025
CompletedNovember 21, 2025
November 1, 2025
1.7 years
January 26, 2022
October 10, 2025
November 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
UUI Responder
Proportion of TNM subjects experiencing a reduction of 50% or more in daily urinary urge incontinence (UUI) episodes (UUI responder rate) at 6 months after device implant.
6 months
Secondary Outcomes (4)
UUI Change From Baseline
6 months
UF Change From Baseline
6 months
UPS Change at 6 Months
6 months
OAB-q Change From Baseline
6 months
Interventions
Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.
Eligibility Criteria
You may qualify if:
- Subjects 18 years of age or older
- Qualifying voiding diary
- Have a diagnosis of UUI for at least 6 months
- Failed and/or are not a candidate for conservative therapies.
- Willing and able to accurately complete study diaries, 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:
- Have primary stress incontinence
- History of a prior implantable tibial neuromodulation system
- Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
- Previous pelvic floor surgery in the last 6 months
- Women who are pregnant or planning to become pregnant during the course of the study
- Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
- Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (29)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Georgia Urology
Cartersville, Georgia, 30120, United States
Northwestern Medicine
Chicago, Illinois, 60611, United States
Providea Health Partners
Evergreen Park, Illinois, 60805, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70006, United States
Chesapeake Urology Associates
Towson, Maryland, 21204, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
Minnesota Urology
Plymouth, Minnesota, 55441, United States
Mayo Clinic Urology
Rochester, Minnesota, 55905, United States
Summit Health Englewood
Englewood, New Jersey, 07631, United States
Summit Health Voorhees
Voorhees Township, New Jersey, 08043, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Associated Medical Professionals
Syracuse, New York, 13210, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Alliance Urology Specialists
Greensboro, North Carolina, 27403, United States
FirstHealth Urogynecology
Hamlet, North Carolina, 28345, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Wright State Physicians
Fairborn, Ohio, 45234, United States
Central Ohio Urology Group
Gahanna, Ohio, 43230, United States
Urology Surgeons of Oklahoma
Oklahoma City, Oklahoma, 73120, United States
Prisma Health
Greenville, South Carolina, 29605, United States
Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic
Sioux Falls, South Dakota, 57105, United States
Urology Partners of North Texas Research Institute
Arlington, Texas, 46017, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Ascension Columbia St. Mary's
Milwaukee, Wisconsin, 53211, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mylene Champs
- Organization
- Medtronic
Study Officials
- STUDY DIRECTOR
Mylene Champs
Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
January 26, 2022
First Posted
February 7, 2022
Study Start
January 31, 2022
Primary Completion
October 10, 2023
Study Completion
May 30, 2025
Last Updated
November 21, 2025
Results First Posted
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share