Table 1.

Key TITAN 2 eligibility criteria.

Inclusion Criteria
1. Subjects 18 years of age or older
2. Qualifying voiding diary demonstrating a minimum of 3 episodes of urinary urge incontinence in 72 h
3. Have a diagnosis of urinary urge incontinence for at least 6 months
4. Failed and/or are not a candidate for conservative therapies
5. Failed and/or are intolerant to at least 2 overactive bladder medications or contraindicated for overactive bladder pharmacological therapies
6. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol
7. Willing and able to provide signed and dated informed consent
Exclusion Criteria
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
2. Have primary stress incontinence-based MESA questionnaire or physician evaluation
3. History of a prior implantable tibial neuromodulation system
4. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
5. Previous pelvic floor surgery in the last 6 months
6. Women who are pregnant or planning to become pregnant during the course of the study
7. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
8. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.