A new implantable device placed near the ankle may help reduce urge urinary incontinence by sending scheduled electrical signals to nerves involved in bladder control.

What is urge urinary incontinence?

Urge urinary incontinence (UUI) is a type of bladder leakage that happens after a sudden, strong urge to urinate. 

“With urge urinary incontinence, there’s usually some overactivity of the nervous system,” explains urologist Andrew Christiansen, MD. “That overactivity can lead to bladder contractions that are hard to control and the feeling that you’ve got to go right now.”

How does the Altaviva™ device work?

The Altaviva™ device is a small implant placed under the skin near the inner ankle. Dr. Christiansen describes it as “about the size of a small USB drive.”

The device sends electrical signals toward the tibial nerve. The signals travel along nerve pathways connected to the same nerve roots that help control bladder function. 

“The electrical signaling then helps to reset the nerve function of the bladder, so that there’s less urge incontinence,” Dr. Christiansen says.

Nerve stimulation is delivered automatically three times a week for 30 minutes. Patients may feel the stimulation during treatment.

How is this different from other treatment options?

Neuromodulation treatments for bladder control are not new. One long-standing option is sacral neuromodulation, which involves placing a wire near the sacrum and an implantable battery pack in the upper buttock area.

Altaviva™ is less invasive because it is placed near the ankle rather than near the spine. 

“Nothing is going into the spinal column,” Dr. Christiansen says. “It’s a very quick, easy procedure that can be done under local anesthesia.”

Because the procedure does not require sedation or imaging, it may be an option for more patients. The device is also MRI compatible.

Who may be a good candidate?

Altaviva™ is currently for people with urge urinary incontinence who have not had enough relief from more conservative treatments or could not tolerate them. Dr. Christiansen says good candidates have healthy tissue around the ankle where the device is placed.

Patients may not be good candidates if they have:

• Significant lymphedema
• Peripheral neuropathy (numbness or tingling in the toes)
• Chronic venous insufficiency
• Chronic skin changes near the ankle
• Poor wound healing

 A urologist can help determine whether the treatment is appropriate.

What happens during the procedure?

The outpatient procedure takes about 10 minutes. It is done with local anesthetic through a small incision near the ankle. The device is inserted under the skin, and the incision is then closed and dressed.

The device is activated the same day. Follow-up typically includes a wound check about two to three weeks after the procedure. The battery is expected to last 10 to 15 years.

What results can patients expect?

Results vary from person to person. Dr. Christiansen says clinical data show about two-thirds of patients have at least a 50% improvement in symptoms. Eighty percent of patients report improved quality of life related to their urinary symptoms. 

Some patients may become completely dry, but many experience partial improvement rather than a cure.

“There’s always a potential risk of failure to improve symptoms, or the risk that you may not be completely dry,” Dr. Christiansen says. Still, he notes that satisfaction rates are high among patients who improve.

What are the risks or side effects?

The main risks include infection, wound healing problems, and the possibility that symptoms may not improve enough. Some patients may also experience a motor response during therapy, with movement in their toe or foot, though this is generally not bothersome.

Your care team will review risks based on your health history and the condition of the skin and tissue near your ankle.

Why consider this treatment instead of medication?

Medication is often a first treatment for bladder control symptoms, but it is not the right fit for everyone. Dr. Christiansen says some common medications, including anticholinergics, can cause side effects such as cognitive problems, dry mouth, and constipation. Medications may also be expensive.

“When we look at procedures that can take the place of medications or provide further improvement beyond medications, they can be a good option,” Dr. Christiansen says. 

The goal is to offer a long-lasting, minimally invasive treatment that may help people avoid medication side effects or reduce the need for additional medications.

FAQ: What should patients know about Altaviva™ for UUI?

Is Altaviva™ for all types of urinary incontinence?

No. It is currently only approved for use with urge urinary incontinence, or UUI.

Where is the device placed?

The device is placed under the skin near the inner ankle.

Will I be asleep during the procedure?

No. The procedure can be done with local anesthetic and does not require sedation.

How long does the procedure take?

The outpatient procedure takes about 10 minutes.

How often does the device deliver therapy?

Therapy is delivered three times a week for 30 minutes.

Will I feel the stimulation?

You may feel it. Some people may notice toe or foot movement during stimulation.

How long does the battery last?

The battery is expected to last 10 to 15 years.

Is it MRI compatible?

Yes, the device is MRI compatible.