When it comes to controlling bladder leaks, innovation has often been lacking – there haven’t been all that many advances beyond behavior modification, dietary changes, and Kegel exercises to help you stay dry. At least until now!
Technology is increasingly coming to the rescue, with a number of new devices hitting the market that have the real promise of improving your symptoms. One of the most intriguing of these is the Leva Pelvic Health System, a convenient, easy-to-use, at-home program that combines unique motion-sensing technology with personal coaching to help women strengthen their pelvic floor and decrease the symptoms of stress, mixed and urgency incontinence, including overactive bladder.
In today’s podcast, we talk with Jessica McKinney and physical therapist who’s been closely involved with the development of the Leva system to learn more about what it is and how it works, and we also spend some time discussing the value of physical therapy in coordination with other treatment methods to address bladder incontinence.
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.
I’m your host, Bruce Kassover and today we have with us Jessica McKinney, she’s a physical therapist and an advisor for Renovia, the maker of the Leva Pelvic Health System, which is an easy-to-use, at-home pelvic health program that’s brought real relief to an enormous number of women. So welcome Jessica, thank you for joining us today.
Jessica McKinney: Thank you so much, Bruce. I’m happy to be talking with you.
Bruce Kassover: Well, could you tell us a little bit about your background and your experience as a physical therapist, a little bit about your career and your focus?
Jessica McKinney: Yes, absolutely. So, in brief, I’ve been a physical therapist for a little over 20 years.
At this point I was exposed to women’s health and pelvic health very early in my career. It was actually in my very last clinical training before graduation. And it just really piqued my interest, the combination of the impact I saw that that type of practice had in people’s lives, and it was really clinically interesting as well.
So that kind of started me on my path into women’s in pelvic health. And I continued that largely in an outpatient setting first in the suburbs of Chicago with a great private practice and then moved to the Boston area where I started a private practice with my husband who’s also a physical therapist, and that gave me the chance to really invest in building a team and a program focused on women’s and pelvic health was at that for a number of years.
And we had a large and dynamic team, spent a lot of time working very closely with local urogynecologists, including one specific fellowship program and continued that until I first encountered Renovia about five years ago, and then I kind of had a foot in both of those worlds for a while, and then stepped into working with Renovia full time about four years ago.
One other real key piece. I think about my career that I should add that has happened really interwoven through all of that time, largely since about 2009, has been a lot of work in global women’s health. So primarily in some different countries in Sub-Saharan Africa but really focus on capacity building for women’s health, physical therapy, in low resource settings such as that.
Bruce Kassover: Well, that’s pretty remarkable. So you’ve, you’ve done, done work personally in Sub-Saharan Africa?
Jessica McKinney: Indeed. Yes. That’s actually been a real focus of my career for a number of years and continues to this day. That’s something I’ve been able to continue doing. Haven’t traveled there for a while because of the pandemic, but yes, I have continued to be very involved with a couple of colleagues and institutions there.
Bruce Kassover: Wow. That’s really amazing. Where have you been?
Jessica McKinney: So predominantly our work has been nested in Eastern Congo. It started at a hospital called Heal Africa in kind of the Northeast part and then has really been focused on an incredible institution called Panzi Hospital and their affiliated foundations in the South Kivu area of Eastern Congo,
Bruce Kassover: Isn’t there a terrible refugee situation going on there?
Jessica McKinney: Indeed. Yeah, it’s been a state of, really, ongoing conflict and insecurity for decades at this point and we have incredible friends and colleagues doing critically important work.
Bruce Kassover: Wow. That’s remarkable. As a healthcare worker, is it safe or does it still have some safety risks?
Jessica McKinney: I think relatively safe is, is very fair – that’s a fair way to put it. And I mean, your mobility’s a bit limited and, you know, but we have, have managed to enjoy very safe passage and safe working environments during our time there.
Bruce Kassover: I’m glad to hear that. Apologies that got us a little off-topic by the way, but this really is fascinating to hear.
Jessica McKinney: No, thank you for asking. I always love the opportunity to get to share about that work.
Bruce Kassover: So a little bit closer to home. Can you give our listeners a little bit of education about the pelvic floor and how it relates to incontinence?
Jessica McKinney: Sure. So I think that it’s probably best to think about the pelvic floor as just this, you know, kind of collective name that describes a network of muscles that exist on the inside of your pelvis. So kind of, if you rest your hands on your hips and can feel your hip bones, the top of your pelvis there, the underside of that bony area has an outlet, that is just filled with the muscles of the pelvic floor, and so they kind of fill this space of the pelvic outlet and provide support to all of the internal organs that are there as a part of the, reproductive and of digestive systems and are really involved in many of our functional, day-to-day activities. So they’re, you know, integral to bladder health, to sexual health, provide support and stability, kind of to the spine and the pelvis, with those movements. They’re a really busy group of muscles that are always active in the background, whether we know it or not.
Bruce Kassover: So what does a physical therapist do with the pelvic floor to help address incontinence?
Jessica McKinney: So I’d say in principle, we understand that the pelvic floor muscles kind of have a predictable way that they should be working.
They, so they work involuntarily, meaning that they are, you know, kind of doing a lot of these support type activities without us having to decide that that is happening all the time, but they also have the ability to contract and be trained voluntarily. So one of the things that the physical therapist will do is, you know, conduct a quite thorough history and hear about people’s problems and then do an evaluation and an assessment of kind of all aspects of their body, kind of an external look at their posture and how they’re moving, strength of various muscle groups. And then also doing a similar evaluation internally to the pelvic floor to ascertain, you know, how the muscles are performing in terms of strength and endurance.
And also if there are areas of tenderness, if there are tender points or areas of tightness. So the physical therapist is kind of bringing this big toolkit to bear, to try to understand, what is going on with the person and the issue that brings them into physical therapy, and then in the context of the pelvic floor will approach this through a manner of interventions that may involve exercise techniques, hands on skills, so manual therapy skills, and certainly a lot of education. Think health education is one of the things that physical therapists really excel at when working with people who have pelvic floor disorders. So, you know, in all of our offices, there are anatomical pictures and models that we use to help people understand that this is the location of this muscle group we’re talking about, and this is how it is functionally integrated with the rest of your body and what our findings are may relate to their symptoms and how we choose to address that in therapy.
Bruce Kassover: So what sort of range of pelvic floor disorders can physical therapy really be of benefit to?
Jessica McKinney: Frankly, about as broad as the range is, is where we can show up, you know, physical therapists really have a broad and deep skill set that they bring to the care of people with pelvic floor disorders, so it certainly can be problems such as incontinence, which kind of is the foundation of our conversation today. And that may be bladder incontinence or bowel incontinence, but also defacatory disorders. So someone may see the physical therapist because they’re having, you know, constipation they’re having trouble with either painful bowel movements or trouble evacuating. And I mean, a range of sexual health conditions or concerns can bring someone to physical therapy as well. So, I mean, the list really is quite extensive. People are referred to physical therapists often to manage pelvic organ prolapse symptoms.
Bruce Kassover: Now would somebody tend to go to a physical therapist themselves? Is it usually a referral? Is it, would they get there from a doctor? Is it done in coordination generally with other sorts of treatments and therapies? How does that process work?
Jessica McKinney: You know, we really see that happening in all those manners. So physicians or other clinicians who are commonly caring for people with pelvic floor disorders very regularly have a network of physical therapists to whom they refer. So it is very common that somebody who is seeking PT care has been referred there by a trusted clinician of their own, who they’ve seen for their problem.
But pre-internet may be a bit, but certainly in our, in our connected world, you know, people are online and finding their own answers and hearing about physical therapy through coverage in kind of a, you know, consumer-focused media through, health awareness campaigns led by professional societies or kind of other health focused groups, I mean, such as your own, have heard about it and then looking people up in their community and certainly word of mouth. There are very active moms groups, for example, who may, you know, suggest to other people in their group that physical therapy might be a good option for them and point them in the direction of a few.
Bruce Kassover: Very good. So let’s say that I’m going to a physical therapist, either I was referred or I’m, I’ve made the decision myself or any of the various ways to go to a PT. What can I expect at the first appointment? What is the typical appointment like? How long are they? What happens at an appointment? What would I imagine is the process there?
Jessica McKinney: This is one of those, it depends, right? You always want to lead with an, “It depends…” But the, the typical process is that somebody would have a first appointment that we typically call an evaluation. They come in and there is a conversation with the physical therapist about the symptoms that are bringing them there.
I often phrase it, like, “Tell me your story. Tell me what brings you here today.” You know, we’re really interested in getting at the heart of how the symptoms have maybe changed and evolved over time, what other interventions have been done in the past. Sometimes we’ll see someone where these symptoms are very new, but it’s not at all uncommon to be meeting with someone who’s had symptoms for a number of years.
So that’s a very important piece of that first encounter that often continues over a series of visits. People are probably seen, I mean, if I had to say on average, maybe it’s weekly to start and then appointments might get spread out. Certainly there can be different reasons such as the structure of scheduling at various facilities or the nature of somebody’s symptoms. Something that is more problematic or severe perhaps gets to start with more intensive and more frequent visits up front and then spacing them out. So I think you see a lot of, frankly, a lot of different reasons why there may be some different interaction models. Geography is another example of that, right? Sometimes people come in for their first visit and they are seen less frequently than might be clinically desirable, but a “something is better than nothing approach” allows people to be seen little infrequently or perhaps followed up over telemedicine visits.
Bruce Kassover: Now if I, if I understand correctly, it’s not like you go to the gym and you exercise there and then you just enjoy the benefit of it with, with PT. Is it really more like tutoring and you get homework instruction and then you have to go home and do the homework yourself. And that’s how you get the benefit.
Jessica McKinney: Absolutely. Absolutely. So, you know, the physical therapist is meeting with someone really will go through a lot of work together to try to understand what are the patient’s goals, what are they hoping to get out of the PT, but, you know, it’s really not that the PT is the fixer, you know, but the physical therapist is really the partner and forms an alliance with the patient who is, um, seeking care to make sure that they’re seen and heard, but then also that they are given the information that they can take in. So there’s a lot of learning that is involved and there is homework. So part of the homework is the learning, part of the homework is probably like moving a little differently, living a little differently in your body throughout the day, and that might be taking more frequent breaks. If you’re sitting at your computer a lot, it might be going to the bathroom on more of a strict schedule instead of every single time you might think you have an urge to go to the bathroom. And it might be a walking program or a stretching program.
Bruce Kassover: You know, one other question that, that brings up that gym analogy also is that when you go to a PT, it’s not like you’re going to a personal trainer who happens to just be somebody who’s really fit and wants to show you their routines.
There is some significant education and training that goes into a qualified, licensed PT’s background. So. The people who make use of them can really be confident that they’re getting quality instruction. Can you talk a little bit about what it takes to become a physical therapist in the first place?
Jessica McKinney: Indeed. So, the physical therapy field has undergone quite a lot of change just in the last two decades. So any physical therapist will hold a license in their state, so a professional license in the state in which they practice. We’re at a point where people who are currently in practice based on, you know, the number of years they’ve been in practice, maybe practicing with a bachelor’s degree or a master’s degree or a doctoral degree, or even an advanced doctoral degree, but the field has pivoted so that people who’ve been coming out of school in recent years have a doctoral level degree as their entry into the profession. So you know, that means they’ve completed their undergraduate training and then continued on to what is typically about a three year program, doctoral program that trains physical therapists broadly in many, many aspects of rehabilitation.
So there’s a focus on musculoskeletal issues and neurological issues and pediatrics. And so that people can finish their training with the real kind of generalist sense, you know, that they can go into most practice areas with skills to get them started. And then what you’ll find is that some people might continue on to a specialized residency program and an area of focus, but many people continue to develop their skills within areas of practice through post-professional training. Might be, you know, a couple courses taken over a weekend. Um, sometimes pursuing additional degree certifications or board certifications.
Bruce Kassover: That’s pretty impressive. So tell me beyond being a physical therapist yourself, you’re also involved with Renovia. I’m wondering you could, could tell us a little bit about Renovia and why you decided to join the team there and what your role is.
Jessica McKinney: I’ll kind of back up and say and say that I was very, very busy in the clinical practice that I told you about when we did my intro, that, you know, was this multi-site company in the Boston area, very busy with kind of an influx of referrals and, and patients seeking care for various women’s and pelvic health issues.
And for years we had really been faced with, how do we handle our wait list? Essentially, we were at a perpetual imbalance of supply and demand and we’d grown as a team, had more people and really looked at every training opportunity. We could get to figure out how to expand what we were doing, but I had been personally really seeking out, well, what else is there?
Like, are there ways to think about group based interventions? What about technology? And ways to help us essentially promote access to care and scale that. So that’s where I was personally, when I was introduced to Renovia by the founding CEO and clinical founder. The clinical founder was an OB GYN from Florida; his name was Ramon Iglesias and he really believed that there needed to be a new type of way to provide feedback about the pelvic floor that reflected accurately this lifting component when the pelvic floor muscles contract. And so he did a lot of experimenting and product development to figure out what type of sensor technology and form factor would allow for observation of this lifting and squeezing component of pelvic floor motion during pelvic floor muscle exercise.
Bruce Kassover: And so the end result was the Leva Pelvic Health system?
Jessica McKinney: It was, so his end result was, you know, first generation product that used movement sensors, or motion sensors to move in response to a pelvic floor muscle contraction, and that was communicated to a smartphone app. So the app displays this information to the person using it.
And so I came into the company at that point and there were beginning to do development, additional development to create a second generation of that product with a much more robust app interface where the software really became a driver of the intervention as well as various design improvements on the sensor, the form factor itself. And so I was compelled by this motion-based technology that is pretty unique and new thing in the space of trying to provide feedback on what the pelvic flow muscles are doing during exercise. But because I said I was in this space of really wrestling with how do we reach more people.
I was motivated to participate with the company also in large part because of a desire. Build scale, you know, to really grow a company around this intervention, and to try to get care to more people.
Bruce Kassover: Excellent. And so for women who are going to make use of the Leva System today, how does it work? How do they make use of it?
Jessica McKinney: Right. So you’ll have physically a Leva motion sensor. So it is a device that is FDA cleared. The whole system is cleared for the treatment of stress mixed and mild to moderate urgency incontinence, along with pelvic floor muscle weakness. So, you know, for the purposes of strengthening the pelvic floor.
And so if you have this product, you receive this sensor, which comprises a, a very flexible, um, and relatively. Small intravaginal component. So that is inserted. And you also have your smartphone. So your smartphone then downloads the Leva app. And that is the software that takes in information from the sensors that are placed in the vagina to notice where it is in space, and then to observe what happens when the pelvic floor muscle exercises are being performed. That’s depicted real time on her phone as motion on the screen when she is doing the exercises the correct way. You also would within this app, have additional ways of tracking your symptoms and health education that is built to really help and enhance the experience.
And so when we get started, it probably takes around, I don’t know, 15-ish minutes or so to watch some introductory videos and kind of get yourself oriented. But once that has been established, the actual training component is quite short. It. About two and a half minutes, twice a day. So that’s the recommended dosing of this pelvic floor muscle training program.
So quite, quite easy and convenient and, you know, people can do it at home or wherever they are.
Bruce Kassover: It sounds very clever. You know, one of the things that you often hear, that’s a challenge when people are trying to do Kegel exercises is that it’s hard to really know if you’re doing it right. Everything is internal.
So it’s not like you can see different muscles contracting the way that you might, if it was, you know, your arm day or leg day. And people are never really sure if they’re actually performing it correctly. So this sounds like a pretty ingenious way to give somebody that sort of feedback.
Jessica McKinney: You know, I think it’s a really novel way to provide this type of feedback.
The idea of providing the feedback is not new. There are, you know, inventions that we can find from the 1940s that started to gather information when someone did pelvic floor exercises and find a way to relay that information, to give feedback, because it’s always been hard to know if you’re doing the right thing for muscles that you can’t see… you know, you don’t have as great of sense of where they are in space. And so there have been some other technologies over the last 80 years or so that have looked at that, but you know, when the public floor muscles contract, they have this predictable way of contracting that is a lift and a squeeze, essentially, produces angular motion. So that’s what is communicated in the Leva app. And I, I do think that that is a very novel way to provide feedback, but it also within the training sessions provides feedback on relaxing the muscles back down to a baseline. So because there are motion sensitive, there is a set point when you start and it monitors and guides the contracting component, but then also provides guidance to relax the muscles back down to where they started. So kind of in a training, the biceps analogy, it’s like having something that lets you know if you’ve really bent your elbow all the way up and straightened your elbow all the way back down when you had dumbbell in your hand, as opposed to moving just partway through that range.
Bruce Kassover: I took a look at your YouTube channel and there’s a video there that has a great illustration, not just of how the system works, but also how the muscle contractions are supposed to go. And it really does make it clear in a way that’s rarely communicated. I definitely recommend people check it out if they want to see for themselves.
I’m wondering, though, does the system replace the need for a physical therapist or is it used in coordination with physical therapy? How do you see them working together?
Jessica McKinney: So I will be the first to say and have always said it’s not a replacement. I think it’s more of a replacement for doing nothing, honestly.
What we see from work that our team has done in, you know, looking back at claims data and trying to understand utilization of physical therapy, and what we see in the work of other people in this space is that physical therapists are playing an incredibly valuable role in providing care for people with pelvic floor disorders.
And yet there are a lot of barriers to getting that care. Some of those are at the personal level, there are some people who aren’t comfortable, or they are geographic – they live too far from a PT; it’s not accessible to them in that way. And that the workforce essentially of physical therapists or even other clinicians who can help people to supervise pelvic floor muscle training and other interventions is still limited when we look at it in comparison to the number of people who have pelvic floor disorders.
So I know that’s a kind of a lengthy, explanation, but I think it is really important for us to, to recognize urinary incontinence specifically, but you know, a lot of public floor disorders that are on the scope of being a population health issue, and, you know, we need to look at that, we need to think about different types of options and options that scale. So I would say, you know, if we, if we had everyone, I’d love to see this used in conjunction with physical therapists absolutely. I would not discourage that for a moment; I’d love it
But I think that this is something that, you know, is, has been developed to really stand in a gap that has existed for people to find therapeutic options for their urinary incontinence. And I’m excited for it to be in that.
Bruce Kassover: Now you talk about population health and that brings up a question: I’m wondering, does it make sense? Maybe it’s unrealistic from an expense point of view or an insurance point of view, but does it make sense for people who don’t have active incontinence today to consider using a system like this? You know, we always tell people, “You should do your Kegels. It’s the best way to prevent having a problem in the first place.” So is this for those people?
Jessica McKinney: That’s a really interesting question. So we don’t have, we don’t have data on that to be able to answer it kind of from a real evidence, you know, informed basis. But I mean, that’s one of the reasons why we pursued and, and were granted the clearance for pelvic, for muscle weakness.
So that opens up the door that if there is somebody who has what, you know, their clinician has deemed is clinically relevant weakness or in coordination of the pelvic floor, that they would be able to use this as a system to help them, it would be on-label and appropriate. We don’t have information on prevention specifically for Leva. Certainly pelvic muscle exercises broadly are endorsed for that reason, but it’s a lot harder to study prevention than it is to study something that is treating to improve or resolve symptoms.
Bruce Kassover: Sure, that makes perfect sense. Now, speaking of outcomes, for folks who are using the Leva System and who do have active incontinence, what sort of results do they typically see? I mean, if there is even is something typical that we could say about it…
Jessica McKinney: Yeah, so, I’m happy for when we’re having this conversation because just in recent months we published our pivotal RCT, so randomized controlled trial that was in a population of women who had stress or stress-predominant mixed urinary incontinence, so they had, you know, leakage with coughing, sneezing, laughing, that kind of physical stress, or they had that in addition to some urgency-related urinary incontinence.
And so we did a study where we followed this group for eight weeks and had a comparator group that was doing pelvic floor muscle exercises at home.
So they received written and video instructions to perform their exercises at home. And then we had a group who were doing their public floor muscle training with Leva. And what we saw is that in the two different ways we evaluated a change in bladder symptoms, over the course of this eight week intervention, we saw that the Leva arm, so essentially our Leva group, performed better.
We found in this type of academic work, there is a way to look at the statistical differences between groups, and in that we found that there were what are called statistically significant improvements in both urinary symptoms as reported on a six question survey and their bladder diary. So a document of decreased leaking episodes. What that amounted to is that their leaking episodes went from about twice a day to about twice a week after eight weeks of training. And then with the survey, there’s a way for us to look at not just the statistical difference, so a mathematical calculation, but there are some other scales and ways to look at it that have allowed us to see that the change over time was also that which is deemed clinically meaningful, and that is a difference that was between groups as well.
So what we see is that there are better outcomes, on through different outcome measures in women who were using the Leva as compared to those doing pelvic for muscle exercises at home. And it was an eight week trial, like I said, we saw that they had symptom improvement, so measurable, symptomatic improvement for many people starting by four weeks. And we’re planning to do long term follow up for this group. So we are collecting at least six- and 12-month data and planning to present that at a meeting very soon.
And then if I pivot, we also are able to look at this in our commercial population, which can include people with all types of urinary incontinence, and we are seeing very similar outcomes amongst that group. And we’ll be looking forward to presenting that information in a peer reviewed way as well.
Bruce Kassover: Excellent. So we’re talking about seeing a reduction in leaking episodes. I’m wondering, does that also translate into a reduction in the sense of urgency?
Jessica McKinney: So we were able to see that there were changes on some of these inventories that looked at urgency. So, you know, when the questions address stress leakage and urgency and urgency related leakage, and so we saw improvement in all domains, even though it was kind of first and foremost looking at people who had stress or stress-predominant symptoms.
Bruce Kassover: Okay, very good. Now, if I’m already performing Kegels on my own, and I feel like I’m doing what I’m supposed to, this study, then, would suggest that using the Leva System can still generate a benefit beyond what I’d normally expect to see. Is that a fair statement?
Jessica McKinney: That is a fair statement. I mean, based on, based on this work that we have done, yeah, it is. And that was, yeah, certainly a finding that we’re, we’re very proud of as a team.
Bruce Kassover: Excellent. I, I know that we have to be very careful about what we say, because when we’re talking about medical results, you know, studies look at things very specifically, and we, we don’t want to make any claims that are beyond them.
But even with those caveats, what you’re saying is very encouraging. So if I’m someone who’s listening to what you’re saying, and I’m interested, how do I go about getting the Leva System? What about costs and insurance coverage? What are some of the practicalities there?
Jessica McKinney: Great question. So we’ve worked to develop a product and studied it to see the works.
We have to figure out how people can get it. So there are a few things to say on that. One is that most of the information people would need would be found at levatherapy.com. So L E V A T H E R A P Y.com. And there is a patient specific section there that contains a host of resources. Leva is a prescription product to treat urinary incontinence as health condition.
So we want to be aligned with healthcare professionals. And so it is a prescription product. So there is an order form or a prescription form that is also available and downloadable at the Levatherapy.com site. So whoever is at someone’s clinician who, you know, can write it would write the order for that, it would get faxed or emailed into our office, and we have a team of educators and folks in our Leva Women’s Center who then would reach out and have a conversation with someone about pricing and what would be involved. And then if someone’s chooses to move forward, then they’re matched with a coach in our Leva Women’s Center as well.
And that coach provides motivation and kind of a lot of help around the setup and works with them very closely for a three month period. So that’s some of what to expect. And then you asked rightly about cost. One of the first questions we always get is, you know, is this covered by insurance and, or is this reimbursed, which is a long road for anyone who looks to be able to answer that with a “yes,” ‘ll tell you that.
So one of the, one of the things that we have done is in this trial that I mentioned, it was a key part of our reimbursement strategy. We aim to have this be a covered product, but it is just a, it’s a long game, not a short game, to do that. And so in the meantime, we, have a patient assistance program that allows for a self-pay model in this space of time, between now and getting reimbursement.
Bruce Kassover: And with that being said, I want to thank you very much. I really appreciate you sharing this information with us, and I hope that people have the opportunity to go and visit, LevaTherapy.com that’s L E V A therapy.com to learn a little bit more about the system themselves, and Jessica, I really do appreciate everything you’ve done, and I wish you the best, not just in your work with Renovia and as a physical therapist, but also with the work you’re doing in Africa, helping the people over there, so thank you.
Jessica McKinney: Thank you. Thank you very much, Bruce. This has been a really fun conversation and I appreciate the opportunity to chat with you.
Bruce Kassover: Life without leaks has been brought to you by the National Association for Continence. Our music is “Rainbows” by Kevin McCloud. More information about NAFC is available firstname.lastname@example.org.