Smart pad would provide biofeedback for Kegel incontinence exercises

biofeedback Kegel exercises urinary incontinence

If you’ve ever been given Kegel exercises to strengthen your pelvic floor, you may have wondered if you’re doing them right or if you’re getting better. Two physicians at Boston Children’s Hospital have developed a stick-on pad called NumberOne that could someday tell you.

Carlos Estrada, MD, director of the Spina Bifida Center and co-director of Urodynamics and Neurourology, and Jeanne (Mei Mei) Chow, MD, director of Uroradiology at Boston Children’s both work with children who have urinary incontinence. In the clinic, Estrada has equipment that provides biofeedback as kids practice squeezing their pelvic floor muscles. But parents had been asking for a home solution. “They say, ‘it’s hard to do it at home without getting any feedback,’” says Estrada.

Done right, Kegels can have an 85 percent success rate, he says. But lacking feedback, most people give up on them, including adults. “Adults can get monitoring, but it’s done in specialized clinics with intrarectal and intravaginal probes,” Estrada says.

Most people take a pass on that.

Instead, Estrada and Chow developed a single-use, disposable pad that adheres to the perineal area. They showed off a prototype yesterday at the Pulse@Check Digital Health Care Meetup, hosted by MassChallenge in partnership with Boston Children’s Hospital and Cerner.

Looking like a slimmer feminine pad, it contains two kinds of sensors: electromyography sensors (to determine whether particular muscles are firing and quantify how strongly) and moisture sensors (to detect the degree of incontinence).

NumberOne biofeedback Kegel exercises

As patients do their Kegel exercises, a Bluetooth connection would send real-time feedback to their Android or iPhone. “This is basically like a Fitbit that tells patients if they’re wetting and if their pelvic musculature is getting stronger,” says Estrada.

The pad can be worn with any underwear. “We had been told, users do not want to buy underwear.”

Underserved markets

NumberOne biofeedback Kegel exercisesAlthough children are the patients Estrada sees every day, his research with Chow indicates that the market is far broader. In the U.S. alone, there are more than 65 million women with urinary incontinence. Half of them are under 50, including women who have just had babies. Growing evidence shows that doing Kegels during pregnancy, with good biofeedback, can reduce the risk of incontinence after delivery.

And then there’s aging men, especially those who have had prostate surgery. “In market research, men are the most desperate and the most underserved,” says Estrada. “Kegel exercises work for men, too. The muscles are in the same spot.”

Apps for urinary incontinence already exist that provide “Kegel reminders,” but they don’t provide biofeedback.

“Those are kind of useless,” Estrada says. “If you don’t know if you’re squeezing properly, it makes no difference at all. That’s why people abandon them.”

Pelvic pain could be another “killer app.” Pelvic floor muscle therapy with biofeedback turns out to help patients with chronic pelvic pain. Sexual dysfunction, in both men and women, is another secondary market. “These are markets that are completely underserved, with a very high willingness to pay,” says Estrada.

Persistence pays

Estrada and Chow at first had trouble getting anyone interested in furthering their idea. Mike Dempsey, entrepreneur-in-residence at CIMIT, saw it as just another incontinence product. Many such products have come and gone, and most have failed miserably.

But on Dempsey’s advice, Estrada and Chow signed up for a six-week CIMIT/B-BIC boot camp, a crash course in product design, entrepreneurship and market de-risking. As part of the course, Estrada, Chow and their entrepreneurial lead, Marshall Collins, interviewed roughly 100 providers, industry experts and potential users of their product and refined their idea and pitch. Still, even Boston Children’s Hospital’s Technology and Innovation Development Office (TIDO) chose not to fund the project on the first go-around.

“We kept pushing ahead, revising and honing the idea,” says Estrada. “We have been incredibly persistent.”

NumberOne biofeedback Kegel exercises
Chow (center) and Estrada with Boston Children’s CEO Sandra Fenwick at the Pulse@Check showcase. (Photo: Greg Weintraub)

Estrada and Chow then pitched it to MassChallenge and qualified as finalists to spend four months working in the MassChallenge accelerator. Coached by industry mentors, they created hardware and software prototypes, worked on a website, did more market research and started figuring out payment models. They founded their company and named it NumberOne LLC (based, of course, on “accidentally going #1”).

The MassChallenge experience, coupled with copious market research, seemed to get them over the hump. NumberOne LLC now has a provisional patent filed, as well as a grant from Boston Children’s TIDO and an Accelerator Grant through Boston Children’s Innovation & Digital Health Accelerator (IDHA). CIMIT’s Mike Dempsey is now a supporter, too — and is serving as NumberOne’s interim CEO.

“We’re working with industrial engineers on what the end product will look like,” says Estrada. “Our drive to make this successful comes from our patients and others who we have met who suffer every day from incontinence. Over the next year, the goal is to have a minimum viable product to test on users. Then we will iterate.”