Actively Recruiting
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
Led by MedtronicNeuro · Updated on 2026-05-12
256
Participants Needed
3
Research Sites
345 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidate for Altaviva12 therapy per Altaviva12 labeling
- Diagnosis of Urge Urinary Incontinence with a minimum of 3 episodes in 72 hours documented on a 3-day voiding diary
- If taking overactive bladder medications, stable dose for at least 3 months prior to baseline and willing to remain on stable treatment through 12-month voiding diary
- Willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with study protocol
- Willing and able to provide signed and dated informed consent
You will not qualify if you...
- Not a candidate for Altaviva12 therapy per labeling, including poor surgical candidates or risk for poor wound healing
- Progressive, systemic neurological disease
- Clinically significant peripheral neuropathy in the lower leg
- Severe, uncontrolled diabetes
- Primary stress incontinence or mixed incontinence where stress component overrides urge component
- Current symptomatic urinary tract infection
- Treated with percutaneous tibial nerve stimulation or neuromodulation in past 4 weeks or longer if effect persists
- Treated with botulinum toxin therapy or sacral neuromodulation in past 6 months
- History of prior implantable tibial neuromodulation system
- Pregnant or planning pregnancy during study
- Currently enrolled or plans to enroll in concurrent drug/device study that may affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Urology of Saint Louis
St Louis, Missouri, United States, 63141-8657
Actively Recruiting
2
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
3
Southern Urogynecology
West Columbia, South Carolina, United States, 29169-3456
Actively Recruiting
Research Team
M
Mylene Champs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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