OXFORD — Relevium Lab, located in Oxford, recently introduced a new electroceutical device called Yarlap to help with female urinary incontinence (FUI) and other pelvic floor dysfunctions.
In clinical trials, the device was 84 percent effective in controlling FUI in the study participants. According to studies, approximately 20 million women in the U.S. experience this condition. The statistics increase when you add age as a factor, as 50 percent of women aged 65 or older experience FUI.
Yarlap does not only help with FUI, but also with urge incontinence, according to Brent Reider, Director of Relevium Labs. They are similar, but very different issues that many women suffer. Reider explained, “The pelvic muscles run across your pelvic like a basket. The primary function of the pelvic floor is to hold your organs in position. Now, that is really important and you have to have muscle tone to do that. In other words, you have to have strength and the ability to also relax. For example, if you are pushing out a baby, you have to have strength to push, but you also have to have the muscle control to know to relax.
“Now, relax and control also leads to urinary incontinence. When the basket of organs slackens through disuse your visceral organs fall out of place. What happens is that leads to a thing called stress incontinence. Your organs shift down and back, then your uterus lays on your bladder. That puts added pressure on your organs. Everything is no longer in line, instead laying on top of each other,” Reider said.
“The same thing happens when you don’t use your muscles, your muscles spasms and contracts,” he added. “That is called urge incontinence. Which is when you are going along and all of a sudden you go, ‘Oh, I have to go.’ That is because you are having a charlie horse, basically. This is often confused with overactive bladder. Your bladder is not overactive, it’s the muscles around it that are contracting.”
Operations Manager Mary Ellen Reider added, the term “overactive bladder” is used instead of urge incontinence because it is an embarrassing issue to have. Many women do not want to admit to having these issues, but Relevium Labs would like women to understand the issues are common and treatable.
The Yarlap was a long time coming. According to Brent Reider, he designed seven FDA cleared medical devices. The Yarlap is the first over-the-counter device of its type. “It was a very rigorous application process. I am not an adversary of the FDA, we have a very collegial relationship. Still, because I have so many devices and I know what I am supposed to do, nevertheless it still took a long time to be approved,” he explained.
The Yarlap is an electrode that is inserted into a woman’s vagina. There are six programs in the device. Three are for muscle toning, while the other three are to teach your muscles how to relax. “How this works is, you know when you want to exercise, you send a message from your brain to your muscles to contract and relax. What we do is we put the same mild electrical impulse through the skin until the muscles contract and relax,” Brent Reider said.
MaryEllen Reider added, “When you have a pelvic floor muscle dysfunction, those signals that you are sending from your brain to your muscles, they’re interrupted. What this does is, the Yarlap sends the signal so that even if you have those pelvic floor dysfunctions, or if your nerves down there don’t respond as well, this makes them respond.”
Brent Reider referred to the process as “muscle re-education.”
While age does increase FUI, 19 percent of collegiate females also have FUI. In young women, the issue is teaching the muscles to relax, while in older women it is toning the muscles. That is why there are different programs in the Yarlap. The device is not cleared to treat sexual dysfunction, but the pelvic floor muscles are the same muscles that contract and relax when a woman orgasms, according to the Reiders.
Women are told the benefits of doing Kegel exercises, and the Yarlap has the same benefits and in fact can help women doing those exercises. Over 50 percent of women who do the kegel exercise do it incorrectly — and it does not have the same benefits if not performed correctly, according to the Reiders.
The Yarlap is to be used for a 20 minute maximum at one time. According to MaryEllen Reider, most results from the device have happened after two weeks.
There is no drug interaction with this kind of device. Anybody can use it, except people with pace makers as the signals might interfer. It is currently on the market, and according to the Reiders, is covered by some insurance companies, but people have to call in to see. It treats pelvic floor dysfunctions completely, instead of just treating the symptoms like buying adult diapers, according to its creators. The device also helps maintain a healthy pelvic floor, even after the dysfunctions have been treated.
The response to the Yarlap has been overwhelmingly positive. The device is the size of a lipstick case, and once women find that out they want to try it, according to Mary Ellen Reider. Most devices like this are a larger size and the small size of the Yarlap appeals to women on a broad scale. The device has a timer and can be personalized to the strength the particular woman needs. It even arrives to one’s house inconspicously. “It looks like an Amazon box when it arrives at your house,” MaryEllen Reider added.
Reach Kelsey Kimbler at 937-683-4061 or on Twitter @KKimbler_RH