The ankle, the bladder, and the surprising link that restored this woman’s freedom

Adeana Schmueckle was at the end of her rope.

"I couldn't go anywhere," she remembered. "I felt trapped in my own home. My life was just miserable and I had no idea what to do about it."

Adeana lives with a medical condition known as urge urinary incontinence, or UUI, which causes a sudden need to urinate, often resulting in leaking before reaching a toilet.

It affects millions of people^1,2,3 but it's not easy for some to talk about. "It's incredibly embarrassing to be peeing down your leg as you run through the store trying to get to the bathroom in time," Adeana said. "That happened to me a lot. So yes, I completely understand the reluctance to talk about it."

Nearly 16 million adults in the United States experience UUI.^1,2,3 It's one symptom of a larger health problem called overactive bladder, or OAB, which affects 43 million adults in the U.S.^1,2,3 and is more prevalent than asthma⁴ and is common in both women and men.¹ Yet studies have found that only a quarter of people reporting bladder control issues had discussed their symptoms with a doctor.⁵

Adeana's issues started in her mid-60s and grew worse over a period of two to three years. "Eventually I couldn't travel, not even to see my sister two hours away, because I would have an accident on the way," she said. "I quit my aqua aerobics classes. I always carried extra clothes, and I wore adult diapers every day. It was incredibly depressing."

That changed after she enrolled in a clinical study of a Medtronic implantable tibial neuromodulation device, which is now known as the Altaviva™ device. The U.S. Food and Drug Administration (FDA) recently approved the Altaviva™ device to treat UUI.

How it works

"Who knew that your ankle is connected to your bladder?" Adeana asked with a laugh.

The Altaviva™ device is a small, battery-powered stimulator implanted under the skin near the ankle. It uses electric pulses to stimulate the tibial nerve, which runs down the back of the leg, through the ankle, and across the bottom of the foot.

Here's the interesting and important part for people like Adeana.

Those pulses then run up the leg and connect to the nerve highway that regulates the brain and bladder connection^6-9 and can help relieve urge urinary incontinence symptoms.¹⁰ Traditional practices, such as acupuncture, have long sought to leverage nerve pathways to influence bladder control and laid the groundwork for modern approaches like tibial nerve stimulation.¹¹

"In the beginning, we didn't know how well it would work," said Sarah Tapani, a Medtronic biomedical engineer and the tibial portfolio director who led the Altaviva project from its very beginning in 2020. "It was just a concept. A whisper. So to see it become a treatment that might someday help millions of people is very rewarding."

Current treatments for UUI range from lifestyle changes, such as pelvic muscle exercises, to medication or other advanced therapies, such as injected neurotoxin, surgery or other forms of nerve stimulation.¹² Medications sometimes cause side effects¹³ and don't work for some patients,¹⁴ so the FDA's approval of Altaviva™ therapy opens the possibility of bringing a new treatment option to many more people who need help with UUI symptoms or urgency with leaks.

"I do think this is an important development," said Dr. Keith Xavier, MD, URPS, a urologist at Urology Partners in North Texas. "We have a new way to treat patients long-term, especially those who may not be good candidates for medication or other treatments, through a single, minimally invasive procedure that's done under local anesthesia. This could benefit millions of people."

A dramatic difference

The Altaviva™ device made a dramatic difference for Adeana.

"I just got back from a two-week vacation," she said. "I was able to fly on an airplane for four hours with no trouble. I spent time at a swimming pool. I don't even keep adult diapers in the house anymore."

After years of bladder control problems, Adeana began seeing improvement within two weeks of receiving tibial neuromodulation therapy.* The amount of stimulation can be adjusted, and Adeana said she "barely even knows it's there." The battery is expected to last up to 15 years and only needs to be charged once or twice a year under standard therapy settings.

Managing her bladder control symptoms has restored her confidence and given her the courage to tell others about her experience.

"I'm not real comfortable talking about myself, but I'm passionate about this," she said. "The Altaviva™ device has absolutely made a huge difference in my life. People need to know this is available and if sharing my story helps others, that would be great."

*In addition to risks related to surgery, complications can include pain at the implant site, lower leg pain, infection, and/or technical or device problems. Results vary. Talk to your doctor to see if the Altaviva™ system is right for you.

Important Safety Information

Medtronic Altaviva™ tibial neuromodulation system treats urge urinary incontinence (leakage). It should be used after you have tried other treatments such as medications and behavioral therapy, and they have not worked or you could not tolerate them.

This therapy is not for everyone. The Altaviva™ system is contraindicated (not allowed) for patients who are poor surgical candidates including patients with open wounds, sores, or damaged skin near the treatment area; current or recent history of poor blood circulation in the legs or open sores on the legs from circulation problems; physical changes or previous surgeries where the Altaviva™ device is placed. You must be able to operate or receive assistance in operating the system to be a candidate.

This therapy is not intended for patients who: are not good candidates for surgery or have conditions that make it hard to heal from wounds (such as uncontrolled diabetes, swelling in the lower leg, or nerve problems in the leg); have metal implanted within 5 cm of where the Altaviva™ device would be placed; have a current or unresolved blockage in the urinary tract caused by things like an enlarged prostate, cancer, or urethral narrowing; are allergic to any materials in the Altaviva™ device. The Altaviva™ system may affect or be affected by other implanted medical devices, including pacemakers and defibrillators. Talk to your doctor if you have a pacemaker or other implanted devices. You cannot have diathermy (deep heat treatment using shortwave or microwave electromagnetic energy) if you have an Altaviva™ device. Do not place the charger or ankle band on broken or unhealed skin. Safety and effectiveness have not been established for pregnancy; patients under the age of 18; patients with progressive, systemic neurologic disease; patients with history of urinary retention, or bilateral stimulation.

In addition to risks related to surgery, complications can include pain at the implant site or lower leg pain, infection, wound complications, nerve injury, movement of the implant, undesirable change in bowel or bladder function, uncomfortable or unintended stimulation sensations, unexpected shocking sensation, loss of therapeutic effect, discomfort when recharging, or technical or device problems.

This therapy is not for everyone. This treatment is prescribed by your doctor. Please talk to your doctor to decide whether this therapy is right for you. Your doctor should discuss all potential benefits and risks with you. Although many patients may benefit from the use of this treatment, results may vary.

For complete safety information about this treatment, please visit the Medtronic website at www.medtronic.com.

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References:

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3. US Census Bureau 2020. US adult and under-age-18 populations: 2020 census. https://www.census.gov/library/visualizations/interactive/adult-and-under-the-age-of-18-populations-2020-census.html. Accessed January 31, 2025.
4. Centers for Disease Control and Prevention (CDC). Most Recent Asthma Data, 2024. https://www.cdc.gov/asthma-data/about/most-recent-asthma-data.html. Accessed January 13, 2025.
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9. Bhide AA, Tailor V, Fernando R, Vik K, Digesu GA. Posterior tibial nerve stimulation for overactive bladder - techniques and efficacy. Int Urogynecol J. 2020;31:865-70.
10. Appendix B: Clinical Study Summary. M028929C001 RevC - Clinician Therapy and Programming Guide Altaviva™ Model P7850N. Visca A, Lay R, Sessions AE, Rabinowitz R, Ajay D. History of peripheral tibial nerve stimulation in urology. Urol. 2023;174:3 -6.
11. Visca A, Lay R, Sessions AE, Rabinowitz R, Ajay D. History of peripheral tibial nerve stimulation in urology. Urol. 2023;174:3 -6.
12. Cameron AP, Chung DE, Dielubanza EJ et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder (2024). J Urol. 2024;212:11-20.
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