Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)
- Conditions
- Overactive Bladder
- Registration Number
- NCT05226286
- Lead Sponsor
- MedtronicNeuro
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 188
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary Outcome 6 months 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.
- Secondary Outcome Measures
Name Time Method Secondary Objective 6 months Change in Overactive Bladder Quality of Life Questionnaire (OAB-q) health related quality of life (HRQL) Total Score at 6 months compared to baseline.
Details related to OAB-Q HRQL:
OAB-q HRQL minimum value total score: 33 OAB-q HRQL maximum value total score:198
The outcome is worse the higher the value of the total score.
Trial Locations
- Locations (29)
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
Central Ohio Urology Group
🇺🇸Gahanna, Ohio, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Northwestern Medicine
🇺🇸Chicago, Illinois, United States
Providea Health Partners
🇺🇸Evergreen Park, Illinois, United States
Georgia Urology
🇺🇸Cartersville, Georgia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Chesapeake Urology Associates
🇺🇸Towson, Maryland, United States
Mercy Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Minnesota Urology
🇺🇸Plymouth, Minnesota, United States
Summit Health Voorhees
🇺🇸Voorhees, New Jersey, United States
Mayo Clinic Urology
🇺🇸Rochester, Minnesota, United States
Summit Health Englewood
🇺🇸Englewood, New Jersey, 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
Urology Surgeons of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Wright State Physicians
🇺🇸Fairborn, Ohio, United States
Prisma Health
🇺🇸Greenville, South Carolina, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, 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
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Ascension Columbia St. Mary's
🇺🇸Milwaukee, Wisconsin, United States
Louisiana State University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States