Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)
NCT ID: NCT05226286
Last Updated: 2025-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
188 participants
INTERVENTIONAL
2022-01-31
2025-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Medtronic Implantable Tibial Neuromodulation (TNM) System
Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.
Eligibility Criteria
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Inclusion Criteria
2. Qualifying voiding diary
3. Have a diagnosis of UUI for at least 6 months
4. Failed and/or are not a candidate for conservative therapies.
5. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol
6. Willing and able to provide signed and dated informed consent
Exclusion Criteria
2. History of a prior implantable tibial neuromodulation system
3. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
4. Previous pelvic floor surgery in the last 6 months
5. Women who are pregnant or planning to become pregnant during the course of the study
6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Mylene Champs
Role: STUDY_DIRECTOR
Medtronic
Locations
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Urology Centers of Alabama
Homewood, Alabama, United States
Georgia Urology
Cartersville, Georgia, United States
Northwestern Medicine
Chicago, Illinois, United States
Providea Health Partners
Evergreen Park, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States
Chesapeake Urology Associates
Towson, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Michigan Institute of Urology
Troy, Michigan, United States
Minnesota Urology
Plymouth, Minnesota, United States
Mayo Clinic Urology
Rochester, Minnesota, United States
Summit Health Englewood
Englewood, New Jersey, United States
Summit Health Voorhees
Voorhees Township, New Jersey, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Associated Medical Professionals
Syracuse, New York, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
FirstHealth Urogynecology
Hamlet, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Wright State Physicians
Fairborn, Ohio, United States
Central Ohio Urology Group
Gahanna, Ohio, United States
Urology Surgeons of Oklahoma
Oklahoma City, Oklahoma, United States
Prisma Health
Greenville, South Carolina, United States
Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic
Sioux Falls, South Dakota, United States
Urology Partners of North Texas Research Institute
Arlington, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Ascension Columbia St. Mary's
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT20061
Identifier Type: -
Identifier Source: org_study_id
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