About 37 million — or one in six^(1,2) — American adults suffer from overactive bladder (OAB), while nearly 20 million experience fecal incontinence^(3,4). A stigma exists around acknowledging these pelvic health issues. For more than 20 years, patients have been receiving symptom relief using the InterStim™ from Medtronic, but the company sought technology that would offer a discreet and user-friendly way to put control of the therapy in the patient’s hands.

“For people with untreated overactive bladder or fecal incontinence, their world gets smaller and smaller,” explains Jim Willenbring, senior director for digital health and patient operations at Medtronic. “Their life starts to center on knowing the exact location of each bathroom between home and every place they frequent — work, school, shopping centers, the gym.”

Without treatment, the lives of people with these conditions can become tethered to bathroom locations, with many not wanting to leave home at all, suffering in silence and isolation due to fear of embarrassment.

Medtronic wanted to replace its legacy patient programmer device, which had limited functionality and an obtrusive form factor, with user-friendly mobile devices that patients would be familiar with and would not draw attention to their condition. Through collaboration with Samsung, Medtronic developed a new InterStim™ smart programmer using a Galaxy smartphone and therapy applications. The smartphone is preloaded with Medtronic proprietary software applications that let patients discreetly manage their treatment. 

The goal with improving the InterStim™ system sprang from a desire to make it fit better into a patient’s daily life. Earlier versions of the patient programmer looked like a garage door opener or a pager. “Finding a more discreet device was a major attractor of working with Samsung. Through our work together, we could leverage their smartphones as a platform to give patients the ability to adjust their implanted devices,” says Willenbring.

“The Samsung mobile device loaded with proprietary software applications is called the smart programmer for the InterStim™ system,” explains Lindsey Hanson, senior product manager for Pelvic Health and Gastric Therapies at Medtronic. “The smart programmer phone comes preloaded with the My Therapy application that lets patients check their stimulation level, adjust stimulation provided by the implant, turn stimulation off or on, switch stimulation levels, and change programs.”

“When a patient uses the smart programmer to adjust the therapy, all you see is someone holding what looks to be a typical mobile device, something so ubiquitous that no one questions its use,” says Hanson.

The introduction of the Samsung device occurs during the patient evaluation of the InterStim™ system. The evaluation allows a patient to test the therapy before physically implanting the device in their body. Temporary lead wires are inserted near the patient’s sacral nerve and connected to an external nerve stimulator. That evaluation period lasts anywhere from three days to two weeks. The physician adjusts initial settings, and the patient uses the same platform during the evaluation period to manage the therapy. If the evaluation goes well, the InterStim™ device is implanted and the patient uses the smart programmer.

With the new smart programmer, patients can now manage their InterStim™ implant using a familiar device. The smart programmer allows patients to adjust their therapy in front of others without drawing attention to the fact that they have a pelvic health condition, because it looks like a smartphone. The technology has now been adopted by new InterStim™ patients in the United States and Europe, providing a more user-friendly face to the therapy and putting control into the hands of patients.

Adoption of the Samsung Galaxy smartphone as the platform for the smart programmer within the InterStim™ system was quick. “It took us roughly six months from launch to bring the smart programmer to nearly all our customer accounts,” reports Hanson. “Now new patients in the United States and most of Europe automatically receive the Samsung mobile device as part of the therapy system.”

In many ways, the Samsung smartphone has become the face of the InterStim™ therapy for patients, says Willenbring. “The patient knows the implant is there under their skin, but what they will see, day in and day out for literally years, is the Medtronic application user interface on that Samsung mobile device they hold in their hand,” he says.

Security was a critical consideration in designing the smart programmer. With defense-grade Samsung Knox security built in right down to the chip and a set of secure APIs to leverage, the device, application and patient data are highly protected.

The smart programmer allow patients to adjust their therapy in front of others without drawing attention to the fact that they have a pelvic health condition. Devices are user-friendly, and the smart programmer puts control into the hands of users.

An added benefit of using the My Therapy application on the Samsung smartphone is the ability to track patient behavior and interaction with the implanted device. Charts and graphs help patients and clinicians visualize when the program is on and active, and for how long. Logs show changes in stimulation programs and which programs were used most. Medtronic has opportunities to use that information in the future as it explores a Digital Health program to improve therapies offered and provide patients with more direction for managing their conditions. “Patients tend to normalize the effect of therapy and the resulting improvements. These graphs and charts make the treatment more tangible, helping patients connect the therapy to its impact on their lives,” Hanson explains.

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United Nations, Department of Economic and Social Affairs, Population Division (2011). World Population Prospects: The 2010 Revision, CD-ROM Edition.
Whitehead WE, Borrud L, Goode PS, et al. Fecal Incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009;137(2):512-517.
United States Quick Facts. United States Census Bureau Web site. Available at: http://www.census.gov/quickfacts/table/PST045215/00 Accessed July 19, 2016.
Chancellor MB, Chartier-Kastler EJ. Principles of sacral nerve stimulation (SNS) for the treatment of bladder and urethral sphincter dysfunctions. Neuromodulation. 2000;3(1):15-26.
Patton V, Wiklendt L, Arkwright JW, et al. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. Br J Surg. 2013;100:959–968.
Foster RT Sr, et al., Neurourology Urodynamics. 2007
Tjandra JJ, Chan MKY, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. 2008;51(5):494-502
Siegel S, Noblett K, Mangel J, Griebling TL, Sutherland SE, et al. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim® Therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn.