Long-term safety and durability of the Altaviva tibial device for urge urinary incontinence
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
It will test whether the Altaviva tibial nerve system safely reduces urge urinary incontinence in adults who meet the device's candidate criteria.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MedtronicNeuro Industry-sponsored |
| Locations | 3 sites (St Louis, Missouri and 2 other locations) |
| Trial ID | NCT07456865 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter post‑approval study enrolling adults treated with the Altaviva tibial nerve system to track long‑term safety and effectiveness. Participants must demonstrate urge urinary incontinence on a 3‑day voiding diary and, if on overactive bladder medications, remain on a stable dose. Outcomes include device safety, durability of symptom reduction, and patient‑reported questionnaires with at least a 12‑month voiding diary follow‑up. The study is conducted at multiple U.S. urology and urogynecology centers using standardized device procedures and follow‑up assessments.
Who should consider this trial
Good fit: Adults with urge urinary incontinence who meet Altaviva labeling, record at least three urge incontinence episodes on a 3‑day voiding diary, and can comply with study visits and questionnaires are ideal candidates.
Not a fit: Patients who are poor surgical candidates, at risk for poor wound healing, have progressive systemic neurological disease, or significant lower‑limb peripheral neuropathy may not be eligible or likely to benefit.
Why it matters
Potential benefit: If successful, the device could provide durable reduction in urgency‑related leakage and offer an alternative to escalating medications or more invasive procedures.
How similar studies have performed: Prior studies of tibial nerve stimulation approaches have shown benefit for overactive bladder and urge incontinence, and this study examines the long‑term durability of the Altaviva implementation specifically.
Eligibility criteria
Show full inclusion / exclusion criteria
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 signed and dated informed consent Exclusion Criteria: 1. 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 2. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment 3. Current symptomatic urinary tract infection 4. 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 5. Patients who have had treatment of urinary symptoms with botulinum toxin therapy or sacral neuromodulation in the past 6 months 6. History of a prior implantable tibial neuromodulation system 7. Patients who are pregnant or planning to become pregnant during the course of the study 8. Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound study results
Where this trial is running
St Louis, Missouri and 2 other locations
- Urology of Saint Louis — St Louis, Missouri, United States (Recruiting)
- Institute for Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States (Recruiting)
- Southern Urogynecology — West Columbia, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Mylene Champs
- Email: mylene.champs@medtronic.com
- Phone: 763-526-1627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.