013: This New FDA-cleared Device Will Help You Do Kegels

We all know how important Kegel exercises are for pelvic floor health – they can help prevent or delay the start of leaky episodes, and they can help those who are already living with leaks to get their symptoms under control.

But we also know that Kegels aren’t always easy to do – it’s hard to work out muscles that you can’t see, and who always remembers to keep up with their routine?

That’s a problem that Gloria and Eric Kolb set out to solve. Their solution? Elitone, a comfortable wearable device that provides gentle stimulation to your pelvic floor muscles, prompting them to do your Kegel exercises for you. It’s FDA-cleared and supported in large part with funding from the National Science Foundation.

Listen to this episode of The Life Without Leaks podcast using the player below or check it out on Apple Podcasts, iheart Radio, or Spotify.

Resources:

Kegel Exercises

Pelvic Floor Health Center

NAFC’s FREE 6-Week Pelvic Floor Health Guide

Bruce Kassover: Welcome to Life Without Leaks, a podcast by the National Association for Continence. NAFC is America’s leading advocate for people with bladder and bowel conditions, with resources, connections to doctors, and a welcoming community of patients, physicians and caregivers, all available at NAFC.org.

Welcome back to another episode of Life Without Leaks. Today we’re joined by Gloria Kolb, who’s the founder and CEO of Elidah, the maker of Elitone, and she’s going to tell us a whole lot about that and what it can do for people who are suffering from stress urinary incontinence, in particular, and some other conditions as well.

So, Gloria, welcome. Thank you for joining us.

Gloria Kolb: Well thank you, Bruce. Thanks for having me. 

Bruce Kassover: So, can you tell us a little bit about yourself, how you came to found Elidah, what led you to start trying to do something entrepreneurial that made a difference in this space? 

Gloria Kolb: Yeah. Well, so I have a biomedical engineering background. So I had been designing medical devices, and one of my companies that I founded was in the urology space. And so that’s kind of the first time I’ve heard of incontinence and heard of, you know, what the urologist was kind of dealing with and heard, really, the big size of the market, you know, just how many women, especially women, have issues with stress incontinence.

But then it wasn’t until I had my two kids, three, actually, two pregnancies, three kids. One, my daughter was very large. She was a nine and a half pound baby. And then I had 13 pounds of twins. And so I started to leak when I sneezed and coughed and was just looking for something for myself, and I did not like anything I saw on the market. And so that is why I decided there has to be a better solution.

Bruce Kassover: That makes sense. I guess a lot of women’s first introduction, well, a lot of women’s introduction to a whole lot of changes is, of course, childbirth and raising children. And unfortunately one of those changes for so many people, really, is leaking all of a sudden.

So you certainly, that’s got to be an unpleasant side effect that there are literally millions of people looking for solutions to. So what was your approach? Did you try other products that are out there? Did you sit there and did you say to yourself, “Well, there, there must be something that’ll work for me”? How did you react when you first realized that there was this problem that you had? 

Gloria Kolb: I think like most women, I did nothing. You know, you just start by wearing pads and you know, crossing your legs when you feel a sneeze come on. But it does progress and it does get worse and worse, you know, so after my first daughter, I didn’t really do anything.

And then after the twins, who were, they came about four years later, that’s when I started to look at just what’s on the markets. I did talk to my doctor and I did go to physical therapy. I have to say my experience wasn’t the greatest because, you know, I went to a physical therapy where you’re separated by a curtain and on the other side of the curtain is, you know, a big guy getting his knee worked on. And here I am, totally exposed. But yeah, I just started by looking at other products on the market and trying a bunch of them. 

Bruce Kassover: And did you find anything that happened to make any meaningful difference? I would imagine that if you actually went on an entrepreneurial journey after that, that you probably weren’t getting a lot of success from any of those products.

Gloria Kolb: Well, I would say that the physical therapists help in under… helping me understand what my pelvic floor muscles were and how to do a Kegel exercise correctly, I was definitely not doing it correctly, like a quarter of the women out there. I did try some vaginal devices, but everything that was vaginal required you to lie on your back, lock yourself in your bedroom, you know, with three little kids running around, I just did not have time for that. Plus, you know, it just has that “icky” factor, to be honest. You know, I tried a electrical stimulation device, a vaginal one, and you know, it’s, it was quite strong and it, you know, elicited the Kegel contractions like I know it needed to work. However, I honestly felt, like, violated afterwards, I was just horrified at the experience and I’m like, “There’s got to be something better.” 

Bruce Kassover: You’ve touched on a couple of things that I think are really interesting and that I think will resonate with a lot of people. The first of which is related to the stigma, the uncomfortableness of trying to get help for a problem when you know it’s something that a lot of people don’t like to talk about, they feel self-conscious, there’s embarrassment. There are a lot of, you know, a lot of reasons why people are reluctant in the first place to even go out and seek help and you know, and then you find yourself in a physical therapy environment that certainly wasn’t making that any better. And then when you add the device issue on top of it, I could imagine that you were, you know, one of the things we know is that the, one of the great things about treatments is that there are a lot of different options for different people’s approaches. And I’m sure that you’re certainly joined by a lot of people who just weren’t getting any real satisfaction from any of the standard treatments that were out there? 

Gloria Kolb: Well, I think one of the first things was that I was surprised because, like most people, you know, you just think of incontinence as an old person problem. And here I was in the twenties, I had no warning. Like, my friends didn’t talk, tell me about it. My mom never kind of warned me about it. And my doctors never warned me that this may happen after you give birth. So I was just surprised. I, you know, definitely felt I’m too young for this. 

Bruce Kassover: Yeah, I could appreciate that. I suppose only, it’s only really been the past few years that you start to see people talking a little more about this. You’ll see now commercials on TV for absorbent products and related solutions. So I suppose the conversation is growing, but it really still is in the closet for a lot of people and, and very unexpected.

Gloria Kolb: There’s that embarrassment factor and the stigma. Yeah. 

Bruce Kassover: And you also talked about how not only did you, weren’t you expecting to have leaks at all, but I would imagine that if you ask people, they don’t really understand that there are different types of incontinence that they might be dealing with as well.

Gloria Kolb: What I had was called stress urinary incontinence, which is the most common for the younger women. That is a physical issue where the pelvic floor muscles supporting everything above it just become weak. You know, it’s traumatized really by giving birth, and so when you cough and you sneeze or you run or you exercise, it puts pressure on your bladder, and then the muscle underneath, the sphincter holding it, the urethra closed, is just not strong enough.

So that most starts when you’re younger and then as women age or everyone ages, urge incontinence becomes more of an issue. And I know that this podcast has talked about urge incontinence a bunch before, but you know, it’s that urgency when you just have to rush the bathroom. That affects usually as you get older.

The last thing is there is a good portion that has a little bit of both, and that’s called mixed incontinence.

Bruce Kassover: Yeah, the best of both worlds, I suppose. Now, you were also talking about how you weren’t really sure that you were even doing the pelvic floor exercises correctly, and I think that that’s pretty common.

I mean, we’re talking about trying to exercise muscles that are internal. You can’t really see what you’re doing and it’s difficult to describe to somebody in a way that is really easy to understand, “Oh, that’s what it is, and that’s when I’m doing it right, and that’s how it’s supposed to feel.”

Gloria Kolb: It’s such a great thing that now there’s a lot of YouTube videos that can help explain things, but back then it was like reading a pamphlet and how do you learn how to, you know, do a muscle exercise, a muscle you can’t see by reading a pamphlet,

Bruce Kassover: So now you have this problem. It’s a personal problem, it’s an unexpected problem, and you’re not finding anything on the market that’s really bringing any sort of satisfactory results. So what do you do then? 

Gloria Kolb: You know, it takes a while to get real help. So you, you still go on with, like, wearing the pads. However, once it really starts to affect your quality of life, you know, for me it was, I was running a race and you know, when at the end of the 5k, you know, fun run, you know, I was like, holy cow, I cannot stop. I just gotta go straight to the restrooms. Once it starts to really start to get into your life and what you are doing, that’s when you know, something more serious needs to be done. But you know, we do have and I say we, my co-founder is my husband. He also has a biomedical engineering background. So we started doing research, we started going online, started looking at journal articles, and we found some research coming out of Brazil that showed that surface electrodes worked just as well as the vaginal electrodes. However, this required a doctor to place it precisely in the right spots. You know, you had these four patches and these eight wires and you know, no one can do that at home. And so we figured, gosh, if we could just put it all together so that it’s a one-step, easy placement.

And that’s, so that’s how we started to design our products. But I should back up and say that electrical stimulation has been around for 40, 50 years for incontinence. It’s just that, you know, typically, kit required you to go into the doctor’s office and then, you know, once it was even brought home, you know, it’s just the form factor that doesn’t make it easy to continue with the treatments.

Bruce Kassover: And so you and your husband were, you have a biomedical background, but this sounds like there’s a lot of engineering that’s involved as well. So what did, once you have the idea and you think that this is a concept that should work, how did you actually take it to develop a product itself? What was the next step there? 

Gloria Kolb: So, you know, we did use off-the-shelf parts. So we found off-the-shelf generators that, you know, produces the current, and then we took these TENS patches that’s usually used for pain management and that’s what these doctors’ research that we found, that’s what they were using as well.

But we started to play with the materials, combine it into different shapes, you know, put it on a substrate. We started to play around with that and we started to have people wear it. Our friends are very nice to us. You know, we would just say, do you know, try it, you know, not that we would turn it on, but just like, does it fit the anatomy? Does it, you know, is it the right shape? Too long? Too, you know, and then we just step-by-step going through that process. 

Bruce Kassover: I’d imagine that you have to introduce that topic after the bottle of wine at dinner.

Gloria Kolb: Yeah. That, that’s a good thing. Get that them all liquored up.

Bruce Kassover: Exactly. But it’s nice having good friends who are able to do that. So you developed a prototype and I guess that you found that people were saying that, “Yes, it was doing what it was supposed to do.”

Gloria Kolb: Yeah. And then the next steps are, you know, some clinical studies. We need to get them approved so that it’s safe. And then, you know, starting to, not an efficacy study, but just a single, you know: “Sit here and turn it up,” you know, “Does it contract your muscles? Does it do what it’s says it’s going to do?” You know? So just step-by-step, you start with the acute studies. That was enough to get some funding. We were very blessed to get funding from the National Science Foundation. You know, I think the government really sees that incontinence is a big US healthcare issue.

It ends up being a 20 billion issue to the US healthcare, you know, the number one reason why people enter nursing homes, it’s a big quality-of-life issue. So luckily for us, we do get funding from them. 

Bruce Kassover: We do always say that it is the biggest problem that nobody wants to speak about. And when I, I believe that there are more people who live with incontinence-related issues than people who suffer from diabetes, for example. I mean, it’s truly an enormous problem and also an enormous opportunity to deliver products that really do change people’s lives. Like you said, it is the number one reason why people enter nursing homes. So anything that we can do to cut down on, well, in your case, especially, I suppose we’re talking about products that are useful to a younger audience, but does the product that, that you’ve developed, does the Elitone product also work with older patients as well?

Gloria Kolb: It does. You know, I should say stress incontinence can affect anyone at any age. It’s just that oftentimes it does start with the younger ones. But other times, you know, women who, you know, say they don’t have incontinence at 50 and 60, but at 70 years old, then they start to lose, start to have some bladder leaks and, and that’s just because it is muscle weakness, right?

So after menopause, you start to lose some hormones, you start to lose muscle tone all over your body. And I know. A lot of people don’t think, oh, that it’s a menopause issue, but just the changing body tone, you know, it incontinence as well. 

Bruce Kassover: So at this point, are you ready to go to market or is there anything else that you need to do to the product first, before you start to actually commercialize it?

Gloria Kolb: You know, there are a few other steps. And so that is a more, uh, stringent clinical study efficacy study where we are testing the device for six weeks, you know, to see if it, how well it does to reduce those leaks. And then the FDA approval was not easy. We had to go back and forth, uh, with them three or four times.

It’s all good, you know, because the FDA, I know some people think of the FDA as the enemy, but the FDA is really just trying to protect people to make sure that it’s a safe and efficacious product. So I am happy that they were pushing us because, and I do want to say, because there are a lot of products out there on the market that don’t have FDA approval, and I do want listeners to be aware of that, or they got FDA approval as.

Kind of like a sex toy, but then they are, you know, marketing it for incontinence, which is wrong, because that means that they don’t have any clinical studies. So in any case, we, we did have to go through all of that, but it’s a good thing. 

Bruce Kassover: Oh, it sounds like a great thing. So tell me, what did the, when you actually did the full clinical studies, what sort of results were you finding?

Gloria Kolb: You know, it was, it was really amazing, because that was really the first time that we were getting studies where we got feedback from the user saying, “It changed my life,” like, “I could not dance before and I, and I’m dancing now,” “You know, I did not leave the house and now I am leak free.” So to hear the results was just, oh gosh, heartwarming in that it validated why we just spent five years, you know, struggling through all development of it. 

But in terms of, you know, the data, we were seeing, for example, on the quality of life’s questionnaire, the FDA considers a two point increase in this standardized questionnaire a huge success. Well, we were getting like 12 to 14 point increases in the quality of life of what people… 

You know, the FDA considers anything above 50% improvement, statistically significant, and we were seeing 75% improvement, so, you know, in a short six week period. So it was just really, really good results. The other thing that I think is interesting to note is women on average were in incontinent for 11 years before they joined our clinical study.

I mean, that just kind of shows how long women are waiting, how long they go, you know, suffer in silence. And that also kind of shows that there, there are really no other easy treatments out there. If there was something easy, people would do it much sooner, I hope. 

Bruce Kassover: I think that makes perfect sense. So tell me more specifically, So you have this product that has built-in conductive areas and it’s easy to fit on so it’s, it’s properly positioned anatomically. What happens then? Is there, there’s some sort of external, is it battery driven and like a controller of some sort? How does that work? 

Gloria Kolb: Yeah, sure. Let, let me explain it a little bit. So we call it a gel pad, and it’s about the size of a pad, and you place it in the same area where a pad is.

So there’s, you know, conductive areas near your pubic bone, and then there’s conductive areas near your, you know, your anus. And it’s, then there’s a controller that’s about the size of a matchbox. It is really, really tiny and it sends current to this gel pad so that the current goes through the muscles, the pelvic floor muscles, and that is enough to tell the pelvic floor muscles, “hey, contract, contract the muscles,” much like your brain sends electrical current to the pelvic floor muscles to say “contract” when you’re doing your Kegel exercises. 

So I wanted to point out that, you know, a lot of people hear “electrical stimulation” and they get scared. Oh, it sounds scary, “electrodes” sounds scary, but it’s simply the conduit that, you know, your brain tells any of your muscles to contract, is it just sends a little current through the nervous system that reaches the muscle and the muscle contracts, so that’s pretty much all it is.

Bruce Kassover: So what does it feel like? 

Gloria Kolb: So you just feel a tingling on the surface where, you know, the current’s coming through the skin, but then as you increase the intensity and the user is totally in control of how high she goes, then you just feel pulling inward and this tightening of the muscle on the inside.

Now, I do want to say that one thing that makes our device very different and which is why the surface e-stim has not been done before is, if you took any typical of electrical stimulation machine and you just place it on that private area, that sensitive area, it would probably hurt. But the way we’ve designed our generator is that we have three wave forms.

The first one is a high frequency, that’s kind of like the carrier. It, you know, like the hypodermic needle that just gets past the skin and the fat barrier to reach the muscle. And then the second wave is really. The frequency that on a macro level the body sees it and it goes, “Oh, okay, so that tells me to contract the muscle.”

And then the third one is, behind the stress incontinence signal is actually an urge incontinence signal. So we give both signals. So it that last signal just tells that overactive bladder to calm down. 

Bruce Kassover: It does sound to me like the sort of process that somebody who has used the TENS unit might be familiar with. I know that the way that it acts certainly is not a TENS unit, but it does sound like in this sense of, you have different wave forms, there is electrical stimulation, there’s a small control, you can control the intensity. If somebody’s used the TENS unit, is this something that will be at least somewhat familiar with them in the way it works?

Gloria Kolb: Yeah. Yeah. It, it’s similar in the mode of action. Mm-hmm, but then the actual wave forms are quite specific to incontinence. 

Bruce Kassover: I would hope so! Absolutely. So how is this different from doing, Kegel exercises on your own? 

Gloria Kolb: So, you know, women are told to do Kegel exercises like three times a day, which is a lot. And then it’s just hard to do it enough. Like maybe you work on it, you could work, you could do maybe five minutes, you know, if you’re really good, maybe eight minutes, 10 minutes. Our device stimulates those pelvic floor muscles for 20 minutes and in that 20 minutes does a hundred Kegel contractions. It does it in the correct way. The second thing, it does it longer and stronger than women can do on their own. So that just overall makes it more effective. 

Bruce Kassover: That makes sense. And what about in regard to physical therapy? If you are having physical therapy, is this something that could be a potential replacement for it or an adjunct, or is it just sort of up to whatever you’re most comfortable with? How, how do you see those two working together? 

Gloria Kolb: I see them very different. So physical therapy is great for teaching women how to do the Kegel exercises and then if they have any other issues, pelvic pain, or maybe they’re actually too tight instead of the weak muscles. Then physical therapists are really the only ones that can help with that.

But in a lot of other physical therapy sessions, they do use, you know, vaginal e-stem. So this device can be used as an adjunct because women really need something at home so that they can do it more often. Physical therapy can be costly. It’s not always covered by insurance, but you also have to make, make sure that you have time to carve out of your day once a week.

And I do think for when you’re talking about strengthening muscle, you need to strengthen a muscle more than once a week. 

Bruce Kassover: Absolutely. I think anybody who’s done, who’s ever gone to the gym knows that if you only do it once a week, you’re not going to get the results that you’re looking for. 

Now you, you mentioned how there are a couple of different wave forms that can address both stress and urge incontinence. So have you found that Elitone has been generating meaningful results for people with various different types of incontinence as well? 

Gloria Kolb: Yeah. And it came about almost anecdotally in that we would just start to get reviews that said, “Oh, you know, I could sleep through the night now!” and we’re like, “Oh, well we didn’t even look into that,” but I guess that’s, that’s a, a great benefit, you know, of that calming of the, of the overactive bladder, I should say, for that stress incontinence indication for the FDA. Now we have since done our clinical studies on urge incontinence as well and are seeing the same great results, but it’s not yet on the market for urge incontinence.

Bruce Kassover: Okay, That makes sense. 

Gloria Kolb: You know one thing I wanted to say a little bit more about the form factor is, because it is in this thin, thin gel, it’s about the thickness of a dime. It is super thin, super flexible. You can wear it underneath clothes and because you can wear it underneath clothes, you can walk around and during that 20 minute session, brush your teeth or you can at the end of the day, you know, people are cooking or people are walking the dog, anything you need to do, it doesn’t take up your time. And I think that’s one of the benefits of this form factor being so thin, so comfortable and very flexible.

Bruce Kassover: Is there any issue with anybody potentially overdoing it or is that, that not a concern?

Gloria Kolb: Yeah, I guess some people can overdo it, but we are very careful with our emails going out of, you know, starting women off slow and working up to what they can potentially do.

Bruce Kassover: That’s great. So everything you’re saying sounds really intriguing and welcoming. So if I’m listening to this and I’m somebody who thinks that they might benefit from it, how do I go about getting an Elitone system for myself? 

Gloria Kolb: Well, luckily we have over-the-counter approval, so you can just buy it online on our website, elitone.com, E-L-I-T-O-N-E-dot-com. 

And for those that have Medicare insurance, Medicare does cover it. And so, also, go through our website and then we have links to insurance reimbursement. The, you know, the insurance reimbursement, tthey don’t make it easy for you, though. You do have to get a prescription. You do have to have failed Kegels, you know, documented. And then they consider the device a rental for a year. So they don’t make it easy. But for those who do want to jump through the hoops, they can do that as well. 

Bruce Kassover: And how much does it cost, by the way?

Gloria Kolb: It’s $399, which I have to mention, we have payment plans that make it the same price as pads, you know, in the $30-a-month arena.

But a lot of people say, “Oh gosh, you know, I don’t have that extra amount of money. It’s too expensive.” And then there was a study from the NIH that looked at thousands and thousands of people and they concluded on average, women spend $750 a year on pads and maintenance by doing nothing. So incontinence does cost you something, whether you think it does or not, and if you add up all the pads, you’ll probably be surprised by how much you really spend.

And then it get worse; it does get worse over time. So I do highly recommend people get treated earlier. Get treated, you know, even if it’s not our device, get treated with some device because it’s just better for your health and it’s better in the long run. 

Bruce Kassover: Yeah, I think that not just the cost, but when you go back to the fact that you said that you found that the women who were benefiting from this were waiting an average of 11 years, were suffering for an average of 11 years, when you figure how much $399 over 11 years is, I mean, it’s really, as long as it’s not, you know, as long as you can afford it, it’s certainly a reasonable price for an actual lifestyle change. I mean, who wants to go for more than a decade suffering with leaks?

Gloria Kolb: Yeah. You know, and I think that a lot of women don’t put themselves priority. You know, we had one customer who said, I was spending more on my dog’s health and I wouldn’t have thought twice, you know, if the doctor says, “Your dog needs this,” to spend that money, yet I was unwilling to spend that amount on myself. And it’s unfortunate that women don’t often prioritize their own health.

Bruce Kassover: I think that’s an important point. I think that’s a really important point. And I suppose that also for a lot of aging patients, there’s also a sense that it’s inevitable that this is just something that happens and well, there you go, “I’m just going to have to live with it.” They don’t even realize that something can be done other than, you know, stopgaps, right, like absorbent products and things of that nature.

Gloria Kolb: You know, I don’t want to scare anyone. The earlier you get treated, let’s just say it is so much easier to get all the way back to being leak free. The longer you wait, it’s not just the muscles. The ligaments start to stretch and they start to sag and there and then you might have even organs start to fall out called prolapse. It is so much harder to get all the way back to the beginning, if at all. Some people, they went from five pads down to one pad with our device, but that’s going to be it. You know, there are certain limits. So I am just trying to encourage everyone to get treated earlier. 

Bruce Kassover: I think that, that there’s no better bit of advice than that. So when did you go to market and how has business been going since then? 

Gloria Kolb: So we got FDA approval in 2019, and we launched at the end of 2019, you know, and then of course shortly after that COVID hit, which in a way wasn’t horrible because, you know, physical therapists offices and doctor’s offices were closed and so they can find us online.

And so sales have been good in terms of just ramping up as more and more people find out about a product like this. But now that everything’s opened, we are definitely going out to the doctors. In fact, we just came back from the largest gynecology conference and the gynecologists, they see women early and we are just trying to encourage the gynecologist to ask their patients about incontinence because if the doctors don’t bring it up, patients don’t bring it up, but it is so important to start that conversation.

A lot of the gynecologists have typically not had anything to offer their patients besides, “Hey, do your Kegels.” And then when Kegels fail, you know, they send them out to urologists. But there is something in between that Kegel and surgery. There is, there’s definitely conservative measures that you can do.

Bruce Kassover: Now since you’ve launched and it’s really only been, it’s only been a couple or three years since, since you’ve gone to market, you’ve gotten a lot of recognition, you’ve won some awards, you’ve been on some TV, so tell me, how has the market received the product?

Gloria Kolb: You know, the market has been very accepting. I do think more and more competitors are coming onto the market, but in a way that’s all good because that helps raise the awareness of what’s available. And the more we could get women tto think about their own health and get treated, the better. But we, you know, we, to be honest, we have a lot of work to do too because the market is large and I feel like we’ve only barely tapped into the market.

Like not, and not even in terms of our revenue. I’m just talking about, women should not feel that they have no options or it’s just a part of growing old. So we definitely want to get the word out that it is a very common issue and they should look into their options and get treated. 

Bruce Kassover: Then you said that there are now some competitors that are coming on the market with similar sorts of approaches?

Gloria Kolb: Yeah. One thing that I didn’t mention before are there are a lot of Kegel device types and they have slick marketing. A lot of these Kegel devices, as I mentioned, they don’t have FDA approval. But another thing that the listeners should be aware of is that a lot of Kegel devices, they don’t do the work for you.

They, you know, they have a fancy mobile app and it tells them, “Oh, you’re doing your Kegel. Oh, you’re squeezing and or you’re even improving, you know, your Kegel exercises,” but you still have to sit there with the device in you and you still have to squeeze and do all the work yourself, which is very different than the stimulation devices that actually does the work for you? 

Bruce Kassover: Well you mentioned that they, they might be coming to market with some nice appealing marketing, but I’m sitting here looking at the Elitone website right now and at the picture of the product and the controller device, it looks like it’s beautifully designed. It looks, you know, super ergonomic and tiny and, like, and thin as you were saying. It, it just really looks like a hyper professional product. So I’ve got to say it’s very impressive.

Gloria Kolb: Thank you. Thank you. And you know, we did design it to be super easy to use. So you noticed that there’s only two buttons, you know, either button turns it on and just increase intensity.

We tested it in the nursing homes to make sure that the elderly ladies can understand how to do it and do it. And so we definitely designed it with the consumer as the focus. 

Bruce Kassover: I do want to recommend anybody who’s, who would like a better sense of exactly what the device looks like and to really see just how simple it actually is that the website, elitone.com is, is a great place; it’s a good resource. So what do you see as the future of Elitone? 

Gloria Kolb: Yeah, so we do have our CE mark and so that CE mark allows us to market outside of the US as well. So incontinence is a worldwide issue, and so we are just hoping to improve the lives of women worldwide. I did mention the next product would be the urge incontinence, but after that we actually have, the male device already approved. You know, incontinence is the largest, number one, problem after prostatectomy for urge incontinence for the older men. You know, that’s just as much of a problem as for the women. So we were funded by the Department of Defense to design the male device, and so that’s there. We just haven’t had time to finish the clinical study, so that’ll be next.

And then after that, we may want to tackle pelvic pain, too, because 1 in 10 women suffer from some pelvic pain and there’s nothing on the market. Nothing at all. And we do know that there’s research that can help with pain. 

Bruce Kassover: That’s remarkable. And that sounds like there’s a lot of significant opportunity. The Department of Defense though, what is, what is their interest? 

Gloria Kolb: Well, so they have a lot of injured personnel, right. 

Bruce Kassover: Oh, that makes sense. 

Gloria Kolb: So when you, when you have spinal cord injury, it just leads to incontinence. So incontinence is a big issue with spinal cord injury patients. 

Bruce Kassover: That makes perfect sense. Well, thank you for joining us today, Gloria. I really appreciate your time, and we’ll be sure to put a link to your website in the show notes so anyone who’s interested can find you in a click and learn more about Elitone. 

Life Without Leaks has been brought to you by the National Association for Continence. Our music is rainbows by Kevin McLeod and can be found online at incompetech.com.

Music: Rainbows Kevin MacLeod (incompetech.com)
Licensed under Creative Commons: By Attribution 3.0 License
http://creativecommons.org/licenses/by/3.0/