An amazing new product to treat Overactive Bladder

You may remember Gloria Kolb from a previous episode when she introduced us to Elitone, a wearable device that gently stimulates your pelvic floor muscles, prompting them to do your Kegel exercises for you with virtually zero effort. Gloria is back with us today to introduce her newest product, Elitone Urge, which has shown remarkable results addressing the symptoms of Overactive Bladder, helping reduce those sudden urges to go to the bathroom for thousands of women.

For more information about Elitone, visit them online at www.Elitone.com, and to learn about the Elitone Urge, visit their webpage by clicking here.

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

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Transcript

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. I'm your host, Bruce Kassover, and joining us today is Sarah Jenkins, the Executive Director for the National Association for Continence. Welcome, Sarah. 

Sarah Jenkins: Thanks. 

Bruce Kassover: Today, we are going to be joined by a friend of the podcast, Gloria Kolb. You may remember her from an episode we did last year. She's the founder and CEO of Elidah, which is the maker of Elitone, which is a product to help people address their incontinence issues, and today she has some interesting news about the company and about a new product that she's going to be sharing with us. So welcome to Gloria. Thank you for joining us again. 

Gloria Kolb: Well, thank you for having me on again. 

Bruce Kassover: Excellent. So for those who may not have heard you on the previous podcast maybe you can tell us a little bit about Elidah and how you got started.

Gloria Kolb: Sure. So I can't believe it's been this long, but we started Elidah 10 years ago, and my co founder and I have a background in medical device development, but it was really when I started to see some incontinence needs of my own – I had a nine-and-a-half-pound baby girl, and then 13 pounds of twins – and I was looking for a solution and I didn't like anything I saw on the market. I tried a bunch of different things. And so we, together, my co founder and I, decided we can create something better, something that's easier to use for at home use. 

Bruce Kassover: Outstanding. So now the first product you developed was Elitone. Maybe you want to give us a little briefing about that for those who might not be familiar with it…

Gloria Kolb: Sure. So Elitone is a very simple and tiny neuromodulator. So it's a neuromuscular stimulation, which means that it can do those pelvic floor exercises for you. The nice thing is it's completely external. You just place it on your perineal area, the pubic area, and it does those contractions to strengthen the pelvic floor muscles. It's discrete, so you can, you know, get dressed and walk around the house while it's doing the work for you. 

Bruce Kassover: Excellent. And what is this indicated for? 

Gloria Kolb: This is indicated for stress incontinence, and I would say now that, now that we have a second product, that we gear it for stress and a mixed incontinence. 

Bruce Kassover: Oh, very good. So that's gotta be a pretty large market. 

Gloria Kolb: It is. I believe it's about 85 percent of the incontinence market. 

Bruce Kassover: Wow. Wow. Wow. So that is big, but there are other people who have other things to deal with as well, and now I understand you have something new for them. 

Gloria Kolb: We do. So we have a device that came out last year that's called the Elitone Urge. It is just as discreet and tiny. It's about the size of a matchbox. However, it's for overactive bladder. It is interesting because we did not really intend to go into this market, but, oh, there was such a need! 

Every day, we were getting emails on, “Can it be used for overactive bladder?”, you know, that, “I don't have the stress incontinence problem,” or, “My bigger problem is the urgency, the overactive bladder…” And we found there was a big need. We found that these women were more bothered by their condition, in that they were really tethered to the bathroom. They needed to be very close to the bathroom. They had to schedule everything around going to the bathroom often. So we're happy that we can support that population as well. 

Bruce Kassover: What is the difference between the products that one is more effective or one is, not necessarily more effective, but one is indicated for stress related conditions and one is indicated for urge related conditions?

Gloria Kolb: Yeah, good question. So there are known frequencies that do different things. So 50 hertz, 40 to 50 hertz in terms of electrical stimulation, frequency, is known to contract muscle. And that is what we use for the stress incontinence device. The urge side, between 8 to 12, maybe 8 to 15 hertz, which is a lower frequency, is known to actually calm overactive bladder, it's known to calm very tight muscles. And in our first device, Elitone, we actually sent out both signals. We sent out four seconds for the medium frequency, the 50 hertz, and then two seconds for the overactive bladder. So we were effectively doing mixed incontinence or treating mixed incontinence.

For the Elitone Urge, we only send that 10 hertz to calm the overactive bladder. We know that some people say, “Well, I have both,” or “Why wouldn't I only get the stress incontinence one?” The Elitone Urge does send out three times more signal to calm that overactive bladder, but otherwise the two devices or two treatments are used the same way, they're placed in the same area, they are both 20 minute treatments and then it turns off automatically, and then they both go through this six-seconds-on, six-seconds-off cycles that happens a hundred times in that 20 minute treatment. 

Bruce Kassover: Well, that's very cool. And it's amazing that we understand so much about, you know, the sort of the musculature and the frequencies and the impulses that needed to be done, that's, it's really remarkable. So I guess, if you're somebody who's interested in either of these products, the first point is really understanding what condition you're dealing with. 

Gloria Kolb: Yeah. And we realized that when we launched the Elitone Urge that we were confusing consumers. And so we had to backtrack and put a quiz on our website to first allow people to figure out what do they really have? What bothers them the most? What are their symptoms? And then direct them to the correct treatment for that condition. 

Bruce Kassover: Yeah, it can definitely be confusing. I know that we spend a lot of time talking about the different conditions and even then, you know, it's not always clear to people. Maybe you could talk a little bit about what is the difference, the sort of hallmark differences between the two conditions, just to give people who are listening now a general idea of what they might be dealing with. 

Gloria Kolb: Sure. So stress incontinence is typically starts with weak pelvic floor muscles. This happens often just with unuse of pelvic floor muscles, but often starts right after childbirth for women. So they, the symptoms that they see are they sneeze, they cough, they exercise, and then they have that urine linkage.

So for them, we want to strengthen the muscles. As women or even men age, they might have more urgency where they just have to rush to the bathroom really quickly. It's more a nerve condition in that, you know, the nerves attack the muscles surrounding the bladder and they just almost over fire in that they kind of squeeze the bladder muscles.

And that's that feeling that, “Oh, I have to go to the bathroom right now.” So that's overactive bladder. And then if they leak urine, that becomes urge incontinence. 

Bruce Kassover: Okay. Now for somebody who's skeptical and they're listening and say, “Oh sure, I'm sticking a, you know, a car battery to my, you know, to my bladder,” can you talk a little bit about, I believe that you actually have this validated that it is supported by evidence and the FDA process as well. Is that correct? And if so, can you tell us a little more about it? 

Gloria Kolb: Sure. Yes. So it is a Class 2 FDA cleared device, both of them. You know, electrical stimulation does sound scary. It has been used in incontinence treatments for over 50 years. However, it's always been in a vaginal form for women. You know, it's just, it can be inconvenient. They have to be in privacy, lie on their back. And for many women, it's just icky as well. So one of the reasons why transcutaneous or placing it on the skin just hasn't been done at this point until our device is because it would be painful.

We did differently as we're using a baseline frequency which is at a very, very high frequency, 2000 hertz, which gets past that skin, past the fat barriers, deeper into the muscle so that it's very comfortable. Most women, when they put the gel pads on, they are actually surprised that they don't feel much, that it's, they just feel this tightening on the inside and they actually forget they're wearing it.

We actually had to put a signal at the end of the 20 minutes because women would say, “Oh, it turned off too soon.” And we're like, no, it didn't. You just didn't realize that 20 minutes goes by very fast. So that is one of the differences. The other thing I would say is electrical stimulation, even though that sounds scary, that is the natural pathway that your brain tells any of your muscles to contract. It's sending, your brain is sending electrical current through the nervous system to, you know, your thighs or your, your hand to move. And that's just how muscles work.

Sarah Jenkins: That’s great, Gloria. So, you know, we get a lot of questions all the time from our audience about how effective Elitone is and what other patients experiences have been. Can you share a little bit about what a typical patient might experience? 

Gloria Kolb: Sure. So in our clinical studies – and we've done many – on average, 95 percent of the women improve. And this is in a short, six-week treatment period. 75 percent of that is statistically significant improvement, meaning that they've improved at least 50 percent or more, which is what the FDA considers as a success.

Alongside of that, we've seen 85 percent pad reduction and the results have been very similar with both the Elitone and the Elitone Urge. 

Sarah Jenkins: That's amazing. So when, when someone is looking to use this device, do you recommend a certain level of leakage? Is there, you know, a level where people are going to see more success versus if they're, if they're really heavy leakers, is it going to be harder for them to see success? I guess how do you guys see that? 

Gloria Kolb: Well, we don't recommend, like, waiting too long and, you know, waiting till a minimum amount of leakage because the sooner you can get treated, the easier it will be to get back to being leak free. The more severe people get, it will take longer.

So our clinical studies have been six weeks on average, and we found that these women have, on average, been incontinent for 10 years before they were, they joined our study. So six weeks is quite fast, but many women do need to go longer, eight weeks, 10 weeks. And then of course there is maintenance after that.

Bruce Kassover: Would a patient use this in conjunction with other therapies too? 

Gloria Kolb: Yes. So we've been working with some of the pelvic floor physical therapists. And what we found is that the pelvic floor physical therapists are great in teaching them, you know, where their muscles are, how it should be feeling, yet lots of times they can't go to the pelvic floor physical therapist more than once a week or, you know, once every two weeks.

And this is a great adjunct to use at home. On the flip side, for the overactive bladder, we don't necessarily recommend that they use it with medication. Typically, they start using the Elitone Urge after they tried medication and they realize that, you know, they can't handle the side effects, or the medication's not working for them, or we recommend using it even before medication and definitely before any of the more invasive surgeries. We, when we talk to the clinicians, we definitely advocate that it's a conservative treatment, meaning that if it doesn't work for you, you can still do any of the other more invasive procedures. So we really think it's a great way to start. 

Sarah Jenkins: Gloria, one question that we often hear from our users is, can this product be used for pelvic organ prolapse or for fecal incontinence? Have you guys looked into that or heard people using it in that way? 

Gloria Kolb: Yes. So we do get that question quite often. We have not done clinical studies looking at that specifically, however, we do recommend that for many of these cases, they're, they're told to do Kegel exercises and our Elitone device does help them with Kegel exercises. So for the mild to moderate cases of prolapse and bowel leakage, many people do buy Elitone for that. 

Sarah Jenkins: A lot of patients who have pelvic organ prolapse have a hypertonic pelvic floor as well. How does Elitone help address a hypertonic pelvic floor? And, you know, if you could just also provide a little bit of explanation for our listeners as to what a hypertonic floor is, that'd be great.

Gloria Kolb: Yes, of course. So the hypertonic pelvic floor is when the pelvic floor muscles are actually too tight instead of too weak, which is more common. However, a lot of the symptoms end up presenting the same in that they move, you know, and there's leakage. So unfortunately, I would not recommend the Elitone for them because that would just tighten the floor pelvic floor more.

However, what we are finding is that Elitone Urge actually helps them to relax that pelvic floor muscles. And this was a surprising factor that came later that some doctors were actually recommending Elitone Urge for the hypertonic pelvic floor. And we've gotten enough evidence that we may start a study on that as well.

Bruce Kassover: Yeah. That's really interesting. It almost sounds counterintuitive. 

Gloria Kolb: Yeah, it does, although I do think that for the doctors, it, it makes a lot of sense of what it's doing. It's just relaxing everything. 

Bruce Kassover: Yeah, we got to hope that they know what they're doing. Now, if I did want to get started, do I need a prescription for this?

Gloria Kolb: You don't, we have received over-the-counter indication, which is fantastic because a lot of women don't want to go to their clinicians or they're maybe too embarrassed. So two thirds don't even talk to their doctor about this condition. So we meet them right where they are, which is a device that's easily accessible that they can receive at their home.

Bruce Kassover: How much does it cost? 

Gloria Kolb: It is $400, which is the price point that we find very reasonable for out of pocket, yet there is insurance coverage, too, if you're on Medicare. And we have, one thing that's new is we found that 22 states cover it for Medicaid. However, we do realize that that can still be a large out of pocket fee for some people.

And so we provide monthly payment plans. We provide easy access way to pay with your HSA or FSA funds. And so we truly try to make it very accessible. 

Sarah Jenkins: I imagine that once they have seen success and can reduce the number of absorbent products they're using on a monthly basis that that cost probably ends up evening out or even saves them money in the long run, right? 

Gloria Kolb: Oh, yes. And that's what we're really trying to advocate is that a lot of people just say that up front, I don't have the money,” but we're really trying to say, “Hey, this is an investment. It saves you money on the long run.” And a lot of the things that we're hearing from our customers are, “Yeah, you, you really can't put a price tag on.

So, some of the, the feedback that we get is, you know, “My life's been changed,” “I don't worry anymore,” “I'm saving so much on the cost of pads.” We hear that intimacy has improved with their partner, that their sleep has improved. Their UTIs have improved and, you know, the biggest benefit is, a lot of women are just living life, being active again being kind of free from being tethered from the bathroom and there's just no price tag you can put on that.

Bruce Kassover: I can imagine it's, it probably is for, for those people who really find success, it's got to be genuinely life changing. And I would imagine it's not just a matter of, you know, physical improvement, but also like you're saying, when it allows somebody to sort of regain their life, it's got to be from a mental health perspective, very, very rewarding to see as well.

Gloria Kolb: Yes. Yeah. We've, we've seen so many anecdotal notes from our customers about how they have their confidence back and their freedom. We, you know, for example, one woman, Sherry, she said that she bought an RV and is traveling all over the country now, and she's just never been able to do that before. 

Sleep is also a problem that is such a big issue. You know, it, it's funny because it's one of the things that we're we never had planned to go into the urge or overactive indication; however, in our first clinical study with the stress Elitone device, that was one of the reports was people saying, “Oh my gosh, I slept through the night.” And that was when we realized that We were treating the urge incontinence as well, and that urge incontinence had a big impact on sleep.

Bruce Kassover: I would imagine if there's anything you said that's going to get people really interested in trying to learn more about the product, saying that it can help give you a better night's sleep has got to be one of the things that's towards the top of the list. If that's the case, how do I go and find you guys if I were somebody who would be considering the product?

Gloria Kolb: You can find us at a couple of places, but the easiest is Elitone.com. That is E L I T O N E dot com. We have the most information on that website. There's videos, there's graphs, there's quizzes that you can take to figure out which one is right for you. You can also find us on CVS.com. 

Bruce Kassover: Oh, CVS, that's going to be a nice partnership.

Gloria Kolb: Yeah, it's great. 

Bruce Kassover: That's excellent. But now I'm getting the feeling that, you know, you have a couple of products already. It feels like you and your team are sort of, a little bit of, you know, Thomas Edisons of incontinence coming up with, with new ideas and interesting things. You have anything else on the horizon?

Gloria Kolb: We do. So the other emails and questions that we get every single day is, can men use this? And we would have to say, sorry, sorry, it's, you know, the gel pad was designed for the female anatomy. Well, I'm happy to say that we are now in two clinical studies for males. I do feel like the men are underserved sometimes in that there's a lot of vaginal types of products. There's a lot of treatments for women. And then the men are left hanging. So where we saw some of the biggest needs is post prostatectomy when they have, you know a major surgery and then they're left not being able to go to work for a couple of months or, you know, it's funny because, alright, I shouldn't say funny, but for women, it's more gradual, right? They start with a little bit of leaks. They know that it starts after childbearing, but for men, it's just sudden and it's often very drastic and a lot of leakage. So we are working to address that. The NIH is doing a study and then we are doing a study as well.

Bruce Kassover: Well, that's encouraging. So Gloria, as you know, the name of this podcast is Life Without Leaks, and we always like to end things by asking our guests if they have a little bit of advice, a hint or a tip to help patients live a life without leaks. Just a little thing to remember on the way out. So do you have any one that you might be able to share with us?

Gloria Kolb: I guess I would just love to encourage people to get treated earlier rather than later. There is no cure, but there is definitely steps that people can take to improve their situation. And it does not need to be a big surgery. It can be at-home devices. 

Bruce Kassover: Outstanding, and those are the wise words indeed. I really appreciate you sharing them, telling us about the Elitone Urge and also about everything that you have going on now and in the future. So thank you for joining us. 

Gloria Kolb: Well, thank you so much for having me. 

Bruce Kassover: Life Without Leaks has been brought to you by the National Association for Continence. Our music is Rainbows by Kevin MacLeod. More information about NAFC is available online at NAFC. org.