Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device

Inclusion criteria

• Candidate for Altaviva™ therapy per Altaviva™ labeling
• Have a diagnosis of UUI as demonstrated on a 3-day voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
• If taking OAB medications, subjects should be on a stable dose for at least 3 months prior to baseline and willing to remain on stable treatment through completion of the 12-month voiding diary
• Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol
• Willing and able to provide signed and dated informed consent

Exclusion criteria

• Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including:

• Patients who are considered to be poor surgical candidates or who are at risk for poor wound healing per Altaviva™ labeling
• Have progressive, systemic neurological disease
• Have clinically significant peripheral neuropathy in the lower leg
• Severe, uncontrolled diabetes
• Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment
• Current symptomatic urinary tract infection
• Patients who have been treated with percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) therapy in the past 4 weeks, or longer if the investigator judges that the therapeutic effect is still present
• Patients who have had treatment of urinary symptoms with botulinum toxin therapy or sacral neuromodulation in the past 6 months
• History of a prior implantable tibial neuromodulation system
• Patients who are pregnant or planning to become pregnant during the course of the study
• Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound study results