Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

Evaluation of Implantable Tibial Neuromodulation Pivotal Study

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

Inclusion Criteria:

1. Subjects 18 years of age or older
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:

1. Have primary stress incontinence
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.