It’s a problem no one really wants to talk about — the bladder leaks that can occur when women sneeze, laugh, cough or exercise.
It’s also relatively common: as many as one in three women may be affected by what’s known as stress urinary incontinence, the most common type of incontinence, sometime during their lifespan. So may one in 10 men, most of them after prostate surgery.
For most sufferers, it means relying on disposable pads or underwear, planning errands and outings around restroom availability or even giving up such activities altogether, including exercise.
Ruth Maher, an assistant professor in Creighton University’s physical therapy department, helped come up with a new option to help treat it: what’s billed as the first non-invasive device — called Innovo — designed to strengthen the pelvic floor.
The net of muscles that make up the pelvic floor have to work properly — and in the right order — for us to maintain continence. But they get stretched up to nearly four times their normal length when a woman delivers a baby. Other causes include general laxity, being overweight and menopause. All can lead to loss of control. Yet only one in four will seek or receive treatment, according to a 2017 review published in the Journal of the American Medical Association.
“It really is a silent epidemic,” said Maher, who co-developed the device during her Ph.D. studies at University College Dublin.
The Innovo device is composed of what look like black spandex cycling shorts and a handheld controller. Inside the shorts are eight embedded electrode pads that turn them into an electrical muscle stimulator, similar to the ones a physical therapist might apply to treat an athlete’s injured thigh muscle.
The device delivers 180 contractions over the course of the 30-minute treatment , which is recommended five times a week. It can be used at home.
The U.S. Food and Drug Administration last month cleared the device for use in the United States specifically to treat stress urinary incontinence in adult women. Manufacturer Atlantic Therapeutics, based in Galway, Ireland, plans to make it available by prescription in the United States early next year.
Innovo, initially sold under a different name, has been available in Europe for about six years. Many thousands have been sold, Steve Atkinson, the company’s CEO, said in an email, and the device has been used in about 1.5 million treatments. Currently, it’s available in Europe by prescription from a health care provider and as an over-the-counter device sold through the manufacturer’s website and online partners, such as Amazon. Maher continues to provide clinical advice to the company.
Creighton Therapy and Wellness, a new clinic offered by the university’s physical and occupational therapy departments, will be among the first to offer the device in the United States as a treatment option, Maher said. The clinic at 17055 Frances St. specializes in pelvic health and also offers a pediatric clinic.
Physical therapy is recommended by a number of medical organizations as the first line of treatment for stress urinary incontinence. Surgery generally is considered last on the list. Physical therapy often involves pelvic floor exercises, known as Kegel exercises, that involve contracting, holding and releasing the muscles of the pelvic floor.
But not every woman can do them. Consequently, some may decide that they don’t work.
For those who can’t, supervised physical therapy may be recommended. The 2017 JAMA review cited a cure rate of nearly 59 percent at 12 months for supervised therapy.
Therapists also can use an electrical muscle stimulator in the form of a vaginal probe to stimulate and measure contractions, but it can be used only when a patient lies down, Maher said. Leaks occur when they’re standing up.
Maher said it can be difficult to teach people how to do Kegel exercises, which involve small, invisible movements, without imaging or a digital exam. She compared it to trying to teach a blind person how to control an upper eyelid.
Maher, who’d been interested in science and technology since high school, said she initially started working on the device to find a way to teach the Kegel exercises.
The device goes all the way around the pelvis, she said, so it does a better job of causing contractions and of strengthening and coordinating them.
The data the company presented to the FDA indicates that nearly 88 percent of patients who used it were dry or nearly dry after the 12-week treatment period. Ninety-three percent saw improvement after four weeks.
Maher said she’s planning more research in an effort to get the treatment time down to 10 to 15 minutes and reduce sessions to three a week.
“That’s very attractive for women who are very busy,” she said.
Elizabeth LaGro, vice president of the Chicago-based Simon Foundation for Continence, said the device can provide another option for people. What might work for some might not work for others. What’s needed is a range of therapies so patients and their physicians can find something that works for them.
“We’re just excited that there’s another option out there for people,” she said.
The foundation works to bring the topic of incontinence into the open and provide help and hope for patients and families.
The price for Innovo in the U.S. has not yet been set, but it will be less than the average annual outlay of $500 or more for pads and briefs, said Gordie Nye, chairman of Atlanta Therapeutics’ board. While the device won’t be covered by insurance at first, the company is exploring options. Disposable pads and briefs generally aren’t covered, either.
Maher said she anticipates that Innovo eventually will become available over the counter in the United States.
“Women should be able to treat this at home,” she said.
Eventually, she said, the company plans to release a wireless version that can be connected to a smartphone.
Maher said she’s also focused on prevention, including educating people about the importance of the pelvic floor and offering strategies to strengthen it. Even some young women involved in high-impact sports can have leaks.
“They’re muscles that shouldn’t be ignored, like any other muscle in the body,” she said.