Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

Completed · Not applicable

Conditions studied: Overactive Bladder

In brief

The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.

Key facts

Study ID

NCT05226286

Run by

MedtronicNeuro

People needed

188

Starts

2022-01-31

Expected to finish

2025-05-30

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.