Altaviva implantable tibial nerve stimulation
Altaviva™ is a small implant that sits just above the ankle and treats urge urinary incontinence: the sudden, can’t-wait urge followed by leaking. I offer it alongside InterStim, Axonics, and bladder Botox for women whose urge leakage hasn’t improved enough with behavioral changes and medication.
Medtronic makes the device. The FDA approved it in September 2025, so it’s one of the newest bladder therapies available.
How it works
The tibial nerve runs down the inside of the lower leg. It shares nerve roots with the nerves that control the bladder, so stimulating it near the ankle can quiet the signals behind urgency and leaking.
This isn’t a new idea. Percutaneous tibial nerve stimulation (PTNS) uses a thin needle at the ankle once a week for 12 weeks, then roughly monthly visits to keep the effect. In the sham-controlled SUmiT trial, 55% of women improved with PTNS compared with 21% given a sham treatment. Three-year results showed most responders kept their improvement, but only with ongoing office visits.
Altaviva does the same job without the visits. A small stimulator under the skin delivers therapy on a schedule, automatically. You don’t wear anything or press any buttons day to day.
Who it’s for
Altaviva is approved for urge urinary incontinence. It may make sense if:
- You leak with urgency, not only with coughing, sneezing, or exercise
- Bladder retraining, fluid changes, and pelvic floor therapy haven’t been enough
- Medication didn’t work well enough, caused side effects, or you’d rather not take a daily pill for years
- You want a long-term option that doesn’t involve the bladder itself or repeated procedures
It isn’t the right tool for stress incontinence, which is a support problem and is treated with things like a sling or urethral bulking. It also isn’t approved for fecal incontinence or for trouble emptying the bladder. Sacral neuromodulation (InterStim or Axonics) covers those.
The procedure
The implant goes in through an incision about 2 cm long near the inner ankle. The device sits just under the skin, above the deeper tissue layer, close to the tibial nerve. It’s about 4.4 cm long, a little under 2 inches.
It’s labeled for placement without sedation or X-ray guidance. In the TITAN 2 trial every implant went in under local anesthetic, about a third each in hospital operating rooms, surgery centers, and office procedure rooms. Unlike InterStim or Axonics, there’s no test phase first. Therapy is turned on before you go home, and it runs for 30 minutes every other day on its own.
Expect some soreness at the ankle for a few days. Keep the incision clean and dry until it heals, and we’ll go over activity limits at your visit.
Living with it
At standard settings, Medtronic says the device needs a charge once or twice a year, about 30 minutes each time. The battery is designed to last about 15 years.
You can have an MRI anywhere on the body under the conditions in the device labeling. Tell any imaging center you have it.
Don’t expect results overnight. As with other nerve stimulation therapies, improvement usually builds over weeks to months.
What the results show
Approval was based on TITAN 2, a trial in which every participant received the implant. The 126 people implanted were mostly women (95%), averaged 63 years old, and had already failed or couldn’t tolerate at least two bladder medications. At 12 months:
- 61% had at least half as many urge leaks as before
- 22% had no urge leaks at all
- 80% said their bladder was better
- 67% preferred the implant to the medications they’d tried before
Medtronic funded the study.
TITAN 2 had no sham or comparison group, and I think that’s worth knowing. Bladder symptoms respond to placebo more than most people would guess. In the PTNS trials, about 1 in 5 women improved with a sham treatment. The underlying therapy, tibial nerve stimulation, does have sham-controlled evidence behind it. The implant version is new, and long-term data is still coming in. Medtronic has started a five-year follow-up study.
Through 12 months, 20% of patients had a side effect related to the device, procedure, or therapy. All were mild or moderate. The most common was infection at the implant site (7%), and nearly all of those cleared with antibiotics. Two of the 126 patients had the device removed, one for a wound infection and one for pain at the implant site. Other possible problems include leg pain, uncomfortable stimulation, the device shifting, and the therapy losing effect over time.
How it compares
Third-line OAB treatments don’t have to be tried in a set order. The choice comes down to what you want to avoid.
| Altaviva | InterStim / Axonics | Bladder Botox | |
|---|---|---|---|
| Where | Ankle | Upper buttock, wire to sacral nerve | Inside the bladder |
| Test first? | No | Yes, a trial phase before the permanent implant | No |
| Repeat procedures | None planned for about 15 years | Battery replacement or recharging, depending on model | Repeat injections when it wears off |
| Also treats | Urge incontinence only | Fecal incontinence, urinary retention | OAB only |
| Main tradeoffs | New, no sham-controlled implant trial | Bigger procedure, two stages | UTIs, some women need to catheterize for a time |
In the ROSETTA trial, which compared Botox with sacral neuromodulation, Botox reduced leaks slightly more, but 35% of women on Botox got a UTI and some needed to self-catheterize for a time. Altaviva and SNM avoid the bladder entirely.
If you also have bowel leakage, sacral neuromodulation is usually the better fit, since one device can treat both. If you want the smallest procedure and nothing done inside the bladder, Altaviva is worth discussing. More on the other options: neuromodulation, bladder Botox, and SNM vs Botox.
Insurance
Coverage for a device this new varies by plan. My office checks your benefits before we schedule anything.
References
- Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010;183(4):1438-1443. doi:10.1016/j.juro.2009.12.036
- Peters KM, Carrico DJ, Wooldridge LS, et al. Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study. J Urol. 2013;189(6):2194-2201. doi:10.1016/j.juro.2012.11.175
- Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment 2019. J Urol. 2019;202(3):558-563. doi:10.1097/JU.0000000000000309
- Amundsen CL, Richter HE, Menefee SA, et al. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: a randomized clinical trial. JAMA. 2016;316(13):1366-1374. doi:10.1001/jama.2016.14617
- Lee U, Xavier K, Carey J, et al. Implantable tibial neuromodulation therapy improves symptoms of urge urinary incontinence from the TITAN 2 pivotal study. J Urol. 2026;215(6):702-712. doi:10.1097/JU.0000000000004958