Neuromodulation System Helps Treat Fecal Incontinence

A new neuromodulation system treats patients with fecal incontinence (FI) by targeting the tibial nerve, located near the ankle.

The Bioness (Valencia, CA, USA) StimRouter neuromodulation system is a minimally invasive device consisting of a thin, implanted lead fitted with a conductive electrode, an external pulse transmitter (EPT), and a hand-held wireless patient programmer and controller. Electrical signals are transmitted transdermally from the EPT to a disposable user patch, down the electrical lead to the implanted electrode, and from there to the area of tibial nerve. A typical session lasts 15 to 20 minute, depending on the stimulation program selected.


StimRouter is programmed at the direction of the physician, but it is controlled by the patient to address the specific, changing pain management needs. Small and unobtrusive, the patient programmer creates a wireless connection to the EPT, allowing patients to easily turn the stimulation on or off, increase and decrease stimulation intensity, and select from up to eight stored, custom stimulation programs. An LCD display allows the patients to monitor and manage their stimulation programs and level of intensity. The system can also be used treat chronic pain and overactive bladder (OAB).

“The StimRouter is changing the lives of patients who are looking for new ways to treat not just their pain but also life-impacting conditions, such as fecal incontinence and overactive bladder,” said Todd Cushman, President and CEO of Bioness. “The clinical understanding of stimulating peripheral nerves is allowing for innovative uses of the StimRouter device in Europe, as well as potentially expanding its use in the United States beyond our current chronic pain indication in the future.”

FI and urinary incontinence (UI) constitute a major health problem affecting the lives of an estimated 400 million persons worldwide. Incontinence is also more prevalent in men and women affected by various neurological illnesses, such as multiple sclerosis, spina bifida, Parkinson’s disease, and stroke. Global demographic trends suggest that the incidence of both UI and FI will rise in the coming years, with a significant health and social burden as well as an increased economic cost for both patients and health service payers.

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