You probably don’t give much thought to ankle monitors. But if you do, you likely think of them as restrictive devices meant to keep someone confined to their home.
But a new ankle implant has the opposite effect. It’s offering freedom to women who were previously homebound due to bladder incontinence.
Dr. Cary Fishburne of Novant Health Urogynecology & Surgery - Queensborough in Mount Pleasant, South Carolina, was the first surgeon in the region — and only the second in the state — to implant Medtronic’s new Altaviva device.
What’s the connection between the ankle and the bladder?
They share a neural pathway. The nerve near the ankle and the nerves that control the bladder both come from the same part of the lower spine. So, stimulation at the ankle influences bladder function.
Altaviva is the most up-to-the-minute treatment for urinary incontinence, but the idea behind it has been around since the Shang Dynasty (c. 1600 – 1046 BCE). That’s when the ancient practice of needling for pain relief was first mentioned in ancient Chinese texts.
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A common, but embarrassing, problem
Overactive bladder is a common issue; 30% of women 60 and older and 5% of women 20 and up endure the condition, Fishburne said.
Bladder incontinence can be related to the bladder or the urethra, and treatment options depend on what and where the underlying issue is. Altaviva is specifically indicated for urgency urinary incontinence (UUI)— a component of overactive bladder, a condition that can be diagnosed by a primary care provider, ob-gyn or urologist.
Up until now, treatment options have involved behavioral or lifestyle changes, medications and “advanced therapy options,” which include minimally invasive procedures like bladder Botox and sacral implants such as a pacemaker in the lower back. The Altaviva ankle implant is the newest option.
“Altaviva offers great treatment efficacy in a way that may be more convenient and less burdensome on patients than other advanced treatment options,” Fishburne said.
It’s implanted in a 10-minute, outpatient procedure that can be done without sedation. Fishburne said the implant will eventually be done in your doctor’s office.
“It’s designed to be done even in an office setting,” Fishburne said, “but for now, it’s being done in a hospital setting or ambulatory surgery center.”
Patients can drive themselves home afterward and begin an easy recovery process. They should wear compression stockings for three days and avoid overexerting themselves for about a month. Walking and other normal activities are fine the next day; running or a strenuous hike in the mountains should wait.
And most patients are extremely satisfied with their results. About 60% of patients achieve 50% improvement or better, and 80% say they’re much better with the device. “Another important measurement,” Fishburne said, “is the percentage of patients who would recommend this to friends and family. And that’s around 80%.”
Patients whose leaking episodes aren’t stopped entirely don’t have to go back to being homebound. “This isn’t an all-or-nothing scenario,” Fishburne said. “We all want 100%, but if somebody is 80% better on the ankle device, we can add a medication to that foundation to build their success rate even higher.”
It could take up to four weeks to see full results. But Fishburne has heard from people who were better the day after the procedure.
Who can benefit
The surgeon implants Altaviva — which is half the size of a stick of chewing gum — just above the ankle, “in that little tissue space between the Achilles tendon and ankle bone,” Fishburne said. “It’s placed comfortably just under the skin and not deep down where there are more vital structures — nerves, arteries, veins.”
The procedure may be right for:
- Women who have UUI and can't get to the bathroom in time to avoid leaking. (Those who have urgency and frequency but never leak may not be approved. But that could change, Fishburne said.)
- People who don’t want to be on a daily medicine (and deal with potential side effects).
- People for whom medications haven’t been adequate or otherwise haven’t found a treatment that's right for them.
- Anyone with a healthy ankle. (Those with significant blood vessel disease affecting the lower extremities or with a lower extremity amputation wouldn’t be candidates.)
Fishburne has seen a lot of interest from potential candidates and is often asked if Altaviva might eclipse other techniques. “More of my patients who have been doing needle acupuncture treatment are switching to this,” he said, “because acupuncture requires them to come in weekly for 12 weeks and then monthly afterwards for maintenance.”
It works while you sleep
That’s not the only convenience Altaviva offers. Its battery should last for 15 years. And it only needs recharging once a year. Fishburne’s office sees patients annually for follow-up visits and recharges their battery during that appointment.
Patients receive a remote control that allows them to charge it themselves, turn the sensation up and down or pause it. Surgeons have their own remote that does more advanced programming.
Altaviva implant recipients choose when to program the impulses sent to the bladder. “They’ll feel a vague tingling in their foot, which lets them know the therapy is on,” Fishburne said. “If they find that bothersome, they simply turn down the amplitude. Some patients really want to feel that because it’s a reminder the therapy is on. Others want it to run when they’re not aware of it, so they program it to run when they’re asleep.”
The device functions on its own until the battery runs out. So, there’s no need to take the remote every time you leave the house. When you leave town for a week or two, you probably do want it with you.
Nationwide reputation
Altaviva is almost as simple to implant, Fishburne said, as it is to wear.
Fishburne has been doing sacral nerve implants for many years — and he’s been teaching other surgeons, locally and nationally, how to implant them. He was an early adopter of Altaviva and now teaches other surgeons how to implant it, too. He recently traveled to Chicago for a teaching session.
Surgeons are excited to learn the implant technique, too. Fishburne knows 10 area surgeons who will soon get trained on the device.
‘Her quality of life has exploded’
It’s not often you can improve someone’s life in just 10 minutes, but that’s what Altaviva does.
Fishburne’s first patient was a woman whose bladder incontinence “started to take over her life and became a daily issue,” he said. “She was doing less and less with family and friends.”
The day after her implant, she said she couldn’t even tell she’d had a procedure.
“Her quality of life has exploded,” Fishburne said. “She has fantastic control of her incontinence. She might have one minor episode a week, whereas she was leaking huge volumes multiple times a day before.”
She’s back to living her best life, blissfully unaware of the work her device is doing in the background, thanks to what Fishburne calls the “set-it-and-forget-it” nature of the implant treatment.
Ancient and modern; East meets West
Patients are often surprised by the connection between their tiny technical marvel of an implant and the ancient practice of acupuncture.
Fishburne marvels over the ancients who discovered that an area of the ankle (now called Spleen Point 6, also known in Chinese medicine as Sanyinjiao), can play a role in bladder health. In acupuncture, that point is also related to digestive and reproductive health, menstruation and emotions.
What the ancient Chinese somehow intuited has today been backed by “solid scientific data,” Fishburne said.
“Altaviva builds on that wisdom.”
But patients don’t need to know about Spleen Point 6, meridians, qi (life force) or anything else from eastern medicine to appreciate what the ankle implant does for them. They need only celebrate regaining their freedom.
Altaviva releases them from house arrest.
