Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
MedtronicNeuro
Summary
The purpose of this prospective, multicenter study is to assess the long-term safety and effectiveness of the Altaviva™ system for the treatment of UUI
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Candidate for Altaviva™ therapy per Altaviva™ labeling 2. 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 3. 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 4. Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol 5. Willing and able to provide…
Interventions
- DeviceAltaviva™ system
Programmable neurostimulation system that delivers electrical stimulation to the tibial nerve for tibial neuromodulation therapy.
Location
- Institute for Female Pelvic Medicine and Reconstructive SurgeryAllentown, Pennsylvania