Exploring Non-Surgical Treatments for Stress Urinary Incontinence

In this episode, I dive into various non-surgical treatments for stress urinary incontinence. The show features clips from four different interviews. We start with Mandy Pulliam, CMO of Leva Health, who explains how their device assists in strengthening the pelvic floor. Next, Lauren Barker, CEO of Uresta, discusses her company's over-the-counter pessary. Allison Watkins, CEO of YoniFit, explains the benefits and study results of their prescription-only pessary. Finally, we hear from a woman named Jane, who shares her positive experience with a urethral bulking procedure known as Bulkamid. This comprehensive episode provides valuable insights and options for women dealing with stress urinary incontinence, offering them the tools to make informed decisions about their treatment options.
Looking for more information on these episodes and treatments:

S2E10:Leva Device with Mandy Pulliam
https://www.buzzsprout.com/2112419/episodes/14690011

S2E40: Uresta CEO Lauren Barker on the Transition to Over-the-Counter Availability
https://www.buzzsprout.com/2112419/episodes/16185663

S2E38: Innovating Women's Health: The Story Behind Yoni Fit
https://www.buzzsprout.com/2112419/episodes/16093774

S2E13: Jane's Decision - The Urethral Bulking Procedure
https://www.buzzsprout.com/2112419/episodes/14799586

Timeline:
00:28 Introduction to Stress Urinary Incontinence
01:06 Overview of the Episode Structure
02:21 Interview with Mandy Pulliam on Leva Health
08:08 Interview with Lauren Barker on Uresta 1
13:17 Interview with Allison Watkins on YoniFit
19:54 Personal Experience with Urethral Bulking
28:07 Conclusion and Encouragement

Transcript

Hi there, this episode today is all about treatments for stress urinary incontinence.  So, like you know, stress urinary incontinence is when you're leaking with coughing, sneezing, laughing, exercise. It's more common after pregnancy and delivery. Um, but about 10 percent of women have this their entire lives.

And if you're someone who is looking for treatment options, maybe you've been doing Kegels at home and they haven't been working as well as you want them to. You're not really interested in surgery and you're wondering what else you can do, this episode is for you. So it is a composite episode where I take clips from other episodes.

And there are four different episodes featured here. So the first is about the Leva Health, and it is an interview with Mandy Pulliam, who is the CMO. The Leva Health is a device that helps you strengthen your pelvic floor, and you can do it at home.  The next one is an interview with Lauren Barker, who is the CEO of Uresta, which is a pessary.

So a pessary is a device that you put in the vagina that puts pressure on the urethra and helps stop leaking while you are wearing it.  The third clip is an interview with Allison Watkins, who is the CEO of YoniFit, which is another pessary device.  And then the last clip is taken from an interview that I did with a woman who had undergone a urethral bulking procedure. 

The material that was used in her bulking procedure is commercially known as BulkMed. And it is one of my favorite episodes because she talks so candidly about her experience and how well this worked for her.  So let's go ahead and get started with the first interview. And this is Mandy Pulliam, who is the CMO of Xena that creates the Leva Health.

And this is taken from Season two, episode 10. If you're interested in listening to the full podcast is composed of two things. Uh, one is, uh, a vaginal wand or, uh, the, that gets placed in the vagina. Uh, it's, uh, embedded with accelerometers. Those are the same things that, um, show you the position of your phone, right?

If you move it one way or another, it goes from portrait to landscape. So you're looking at the picture right side up. Um, so those, uh, aligned all together, uh, sort of take on the shape of the vagina when you place the wand in the vagina. And then as you do pelvic floor muscle, uh, training, uh, the lift and the motion of the pelvic floor upwards and forwards, uh, is, uh, reflected, uh, when it connects to your phone.

Um, So in the phone is an app. It contains a ton of educational materials, all designed by a pelvic floor physical therapists. Um, it also contains an exercise program where you perform public for muscle lifts and squeezes, um, for about 2. 5 minutes twice a day.  So, uh, the 2. 5 minutes consists of lifting for 15 seconds and then relaxing for 15 seconds and you do that sequence five times.

Um, so, um, that's what the, the, uh, believe a system is, um, also. Um, uh, a little bit separate from the Leva system, but something we offer as a company is we offer personalized coaching so that every woman who receives Leva is assigned a coach, um, who helps them through, um, understanding how to use Leva, uh, and then, um, helps coach them, uh, so that they meet their goals, uh, and a lot of that is around making sure you remember to use Leva, um, but we watch you through the 12 week program, um, which is how long, uh, uh, women engage, uh, using Leva. 

And leave us unique because you have to have a prescription, right? You can't get it over the counter. And then the other thing about it is it tells you that if you're doing your exercises correctly, right? If you're actually squeezing versus pushing down, which is something that so many women do incorrectly, just because they're very, very difficult muscles to engage.

Um,  Right. You can't see them. There's no joint that's moving. I mean, it, you know, I always feel badly when I say that because I feel like it comes out in an accusatory fashion, right? People just aren't doing this correctly, but it's something that you really need to work on and be taught to do, which I think makes this device so much more effective than anything else because the other strengtheners on the market can't tell you if you're squeezing or pushing down, right?

It just tells you if the pressure is going up. Right. Right. And when you measure pressure, it doesn't tell you if it's the right kind of pressure. It just tells you if there is pressure. So if you bear down, that causes pressure. If you squeeze and lift, that also causes pressure. Yeah. Yeah. And I, I think most people just don't have that, you know, can't tell what they're doing.

I mean, we see that all the time in the office when we examine people. Um, it, it, it is, it's just a hard part of the body to engage correctly. Um, so they do it, uh, twice a day. Five days a week for 12 weeks, correct? That's right. And then how much better? I mean, what can I expect if I do that? How much better?

So, um, so, uh, well, by a year out, uh, um, actually by two years out now, because we just published this data, but over time, two things are true. One is that, um, using Leva is, um, superior, uh, to, uh, doing home pelvic floor muscle exercises on your own. So we've talked about how you can't see those muscles. And I think it, it makes intuitive sense to say that it helps.

Um, but also what we found is that, um, uh, women who use Leva are between two and two and a half times more likely, uh, to report, uh, feeling improved or better, um, from doing the exercises. So using Leva is, is better than the alternative.  So if I. So I'm, I'm thinking in my head, how do I translate that? Right.

When people in clinic ask me, um, so if someone says, okay, I'm, I'm going to use this for three months, you know, what can I expect? Am I going to be, um, am I going to feel like this is the last treatment that I need? Am I going to come back? Am I going to say, oh, well, I'm much better, but I feel like I need an additional line of treatment. 

Um, What so what can I expect? Right. So what we found, um, and, and let me just say before I say this, that, that, you know, how you, um, feel about your urinary incontinence treatment is really about who you are and what your expectations are. So, um, you know,  most of the time.  Women have goals about what they expect from their urinary incontinence treatment, right?

Some women want to go run a marathon. Some women just want to be able to go to the mall without having to rush to the bathroom and leak on the way. And I think the, the, so the level of what we can expect from a cure or a treatment is really about what your experience is and what you need out of your experience.

And so in some ways it's really hard to say. 100 percent of women are treated or this. Um, it's more important to say how many people had improved symptoms and and what those seem like. So, for example, um, we know that after eight weeks of treatment, um, uh, women had an 80 percent overall improvement in leakage episodes.

What that means is that some women had zero leakage episodes in the course of three days when they collected information and some women had. One or two. Um, so I think, uh, you know, is everyone satisfied with that? It depends on what your life is like, but largely 80 percent is a huge drop in the number of leakage, leakage episodes that you have.

Yeah. Yeah.  You're welcome. So switching gears a little bit, and we're going to talk about pessaries. This next interview is with Lauren Barker. Who is the CEO of the Uresta company, and this is taken from season two, episode 40. If you're interested in listening to the full interview, we previously were only available in the U.

S. Via prescription,  but over the last few years, we've been working with the FDA to be cleared as an over the counter product. Which means you no longer require a prescription for Uresta, which is, um, great for us because one of the reasons we actually, your Uresta was actually founded was to have a self managed, self fitted solution for women that they didn't have to go to their physicians to get fitted for. 

And how long does the Uresta last for? When do you have to replace it? So it won't break down or anything like that, but we do recommend replacing on an annual basis. Um, or for hygienic reasons, kind of like when you. Replaced your toothbrush, that sort of thing. Yeah, on an annual basis. Yeah. And, and I would assume, I mean, it's been available for so long by prescription in the United States that I would assume that you have a lot of, um, you know, anecdotal data from that.

Well, not, not only that, but we're actually Canadian based company and we've been over the counter in Canada for several years. Um, so just in the last. No, couple of years, we've sold over 20, 000 arrested in Canada, and we have no, um, no adverse effects, nothing to suggest any concern, which was great. We were able to actually use a lot of that user data when we were going for FDA clearance in the U.

S. Um, so, yeah, so it is. It is definitely been a trusted product already in Canada. Just the opportunity to now bring it to the U. S. as an over the counter product. Yeah, which is amazing. I mean, I really think that there's such a need for this, right? So many women want to manage this on their own. And I think if you're healthy and up to date on all of your annual screenings, it's a totally reasonable thing to do.

Um, so I, I think this is definitely something that's needed and, and women want, um, who is your target audience?  So it's funny because I've had, you know, some women will look at your rest and go, that's for, you know, that's for my mom or that's for my grandma, right? Um, we've had women, or I have specifically personally had with women in their 20s using your Resta and women in their 80s.

So I think as long as you are comfortable with the idea of it, um, there is like, you know, a little bit of like hand dexterity and flexibility to take it in and out. Um, If someone's ever used a menstrual cup, it's a similar, uh, it's a similar, uh, process for taking it in and out, but the biggest thing I would say is, um, you know, generally anyone who is experienced, like, leaves when they cough, laugh, sneeze or chum. 

If they've had a recent vaginal surgery, I would definitely recommend chatting with their physician prior. Um, if they have a more advanced collapse, you're still likely wouldn't be successful for them. So typically, you know, grade one, grade two would still be successful with your Rasta. Um, and then we do, uh, it's not for women who are pregnant and women under the age of 18. 

Okay. Yeah. So pretty broad. Yeah. Um, but I will say like from just chatting with a lot of our customers. I mean, there's a lot of women in their 30s and 40s who use it, maybe just for exercise that are super active.  Um, and then you have women who are starting to go through perimenopause. Maybe they've had a little bit of leakage.

Maybe this is something that's new to them. Um, then they go through menopause and becomes even more prevalent post menopause. It's an issue. So, I mean, it is really quite. Um, it is quite broad. Yeah, I think it always helps people to hear kind of who uses it, right? To see if they kind of identify with that, with that person.

Um, and I, I think it's, you know, important to say that, you know, there are a lot of young women who use this. There are a lot of women who use it just during exercise. There are a lot of women who use it during really intense exercise, right? So. Crossfit distance running. Um, so if you know, you have leaking and those activities, I think, you know, it's, it's a great thing to try.

It's also great for people who don't want surgery or aren't ready for surgery and, and don't have time for surgery. Um, and, you know, from my perspective, as. a surgeon, if someone comes to me and they've tried your resta and it works for them. Um, then I think surgery is also going to work, right? Because the mechanism is the same, it's supporting the urethra.

And so I always take that as, you know, kind of a positive test. So I, I think even someone who's interested in surgery, if they kind of want to know. how effective it might be for them. It's a, it's a reasonable, you know, kind of trial. And I always think you should try the non surgical things first.  Okay. So now we're going to move on to a discussion about the Yoni Fit, which is another pessary.

Um, this pessary is only available by prescription. And this interview is with Allison Watkins, who is the CEO and developed this product. And this is taken from podcast season two, episode 38. So how, how did you come up with this idea? How, how were you first introduced to the idea of a pessary? Yes, so I actually, um, really love to do cardio kickboxing.

There's an amazing instructor here in Oklahoma. And so in my kickboxing class, whenever I was wearing a super plus tampon, that's really whatever I had the worst incontinence was with activity. So I would have to wear a tampon and a pad on my period and. I noticed that whenever I was doing some of the jumping, I felt a little bit more supported whenever I was wearing a larger tampon, but I also didn't have as much urine leakage.

And so that's when there was like this light bulb, what is going on? So I just started researching, you know, online and learned about pessary devices and then just started to kind of think about, you know, if there would be something that, you know, might be. Just more for stress incontinence, because I understood and read that those were primarily for prolapse. 

Which my doctor didn't tell me I had prolapse. It's, it's always amazing to me when women figure that out on their own. I mean, I have so many patients that come in and say, I know when I wear a tampon, I have less leaking and, and some people will even wear it.  Um, when they're not menstruating to help with, uh, leaking.

Um, so then you develop six sizes. Um, and I'm assuming that those six sizes work for most women.  Actually, so we conducted what, from what I can find, it's the most rigorous stress incontinence study that that you can find. So we actually manufactured a sham device as placebo and then Yoni fit device.  So we did a week of baseline, so it was actually 7 days of collecting pad weights.

Um, without a device in place, and then they came back and got all 6 devices and the patients then took the devices home and were self fit. So they determined which device, um, they used themselves. Um, and then they came back to the doctor and, um, the physician then verified that they chose the right size, um, and then they went into actually, they went into the advocacy portion and that's whenever the physician determined whether they had chosen the right size for themselves.

So. 100 percent of our patients were able to find a size that fit them. Um, we did exclude some, you know, like stage 2 or greater of pelvic organ prolapse. We excluded from the study because it really was created for stress incontinence. Um, however, I'm curious to see how the larger sizes would work for pelvic organ prolapse because.

That they weren't used as frequently in the study. Yeah. I mean, that absolutely makes sense to me to focus on the stress incontinence and then see for patients who have both right. What? What benefits there are so that's a big complaint that we get from patients because patients, you know, with traditional pastories, whether it's for prolapse or incontinence, patients have to come to the office and we fit them for it.

Um, and you know, how things work in the office is always a little bit of a. Guess right. It's not until you get into your own life that you realize how well it works. And it can be a little bit of a hassle. And sometimes you have to come back a couple of times before we get the. The right size in the in the right shape.

So I would guess that that would be just a, um, a huge benefit for women and that people would really appreciate that sizing on their own and figuring that out. Did you find that? Or did you find that people were a little bit intimidated about figuring out which one to pick?  So some people are a little bit intimidated about finding out which one to pick.

So for those patients, we have created a sizing chart that the physician just does an exam and mid vagina width basically. And then they just place their fingers on the prescription pad and then they can size the patient and the patient will get two sizes just to determine once they get that kit. Um, you know, because based on where you are in your menstrual cycle, sometimes it's heavier.

Sometimes it's not as heavy, so you need a little more support based on activity or whatever. So that is the sizing kit of two. And then for the telehealth kit is what we're calling it, or the self sizing kit, those kits will come with the three most. Frequently used sizes if the woman chooses to just size herself.

So we really want for it to be up to the patient and the physician. You know, some physicians don't want to do a vaginal exam. And so we want for it to be easy for even like family practitioner, right. To prescribe it if their patient is complaining about stress incontinence. And if I get home, I, if I do the telekit and I have, um, those three sizes, but I need a different size.

They just don't work for me. Then what happens? What's the next step? Then we have additional sizes that they can order. They can either get the full, the next three sizes, or they could just order one size up if they think they're close. Okay. And this is a prescription device, correct? Correct. Okay.  And how well does it work?

I mean, you talked a little bit about the efficacy, but, but what are you finding from your research studies?  So in our studies, 96. 3 percent of the patients did report having at least 50 percent reduction in their leaking. So, you know, that is going to vary based on the patient. Some of the patients did end up being completely dry.

Um, and some of the patients just had the significant reduction in leakage. Um, so I'm really excited to learn more once it's in market to see, you know, further data on that. We have this beautiful instructions that I should send you. We just got it. Um, but on the self sizing and everything, it is, there's just so much information to keep it simple for both the providers. 

This final clip is an interview with a woman who I'll call Jane just to protect her privacy and her experience with urethral bulking. This episode is taken from season two, episode three, if you want to listen to the whole thing. And. She is so honest with her experience that I strongly suggest that you do.

Oh goodness. This is something that affected me very early on, ever since I was a kid. It was, it would always show itself jumping on the trampoline or getting out and running or training. Uh, ever since I was young, I was very aware of, uh, Leaking and just needing to know where the bathroom was, honestly.

And so, um, pretty much coughing, sneezing, being active.  So, did you, once you decided to go ahead with the bulk of it, did you have it done in the office or did you have it done in a surgery center or the operating room?  Um, it was,  I guess technically it was the surgery center, but it was very,  I don't know.

I've had a couple of procedures in like one major surgery in my life. So I'm not super like, I don't get very nervous about it, but it really was kind of like a non big deal. You know what I mean? Um, you do go into the surgery center and you do all that, but, uh, it.  It's, it did not feel as big of a deal as where I was at to get it done, if that makes sense.

It, it totally makes sense. So, but you did have a little bit of anesthesia.  Oh, yes, yes, yes. For sure, for sure. Yeah. So you describe it as kind of a non procedure. So you get there, what happened? Walk me through it.  So, uh, I got there and, um, you know, they got me changed, uh, into my gown and everything. Feeling very fancy, very confident, very fancy.

Yes. And, um, they're very nice and so , I know  I wanted to take my time, but, uh, I, um.  I got in there and I got changed and they kind of just came in and walked me through, you know, each person kind of does their rounds. It's got playing some part in it. They stop by to talk to you. Everyone was so friendly and everyone was just very much like, just being very reassuring of like, this is no big deal.

You know what I mean? Like, this is going to be this is going to be a great thing. And so, for me, getting prepared for it, I was not very nervous. Whenever they, uh, pushed me to the back, I, I was informed after the procedure because it wasn't full anesthesia or anything like that. I, my understanding is that it's just kind of enough to, like, keep you out of it and everything.

And, um, you don't remember much afterwards. And, um,  I was told that I was very chatty  throughout the procedure. So be careful, be careful. 

But no, it was just, it was very simple. We got back in the room. I situated myself on the table. We were all just shooting the breeze and just kind of like having like a morning banter. And then, you know, next thing I know it gets a little cloudy, a little foggy. And I'm, and I'm like in the recovery space, you know what I mean?

It's very quick. How long did it take? Do you think? I feel like it could not have been more than 30 minutes. Yeah. Did you have any pain afterwards?  Yeah, so there was a little bit of discomfort whenever I would be, it would kind of be like, you could, um, feel maybe where they had done the injections and they're a little bit definitely not unmanageable.

Definitely. Not  it was not too much, but you or I did have some burning sensation and I could tell where it was. It was where he had Put the solution there. I think that's pretty common. How long did that last for you? I think that that only lasted  honestly, I think it lasted maybe 4 to 5 days. But, I mean, the 1st, 2 days were definitely the most intense.

And like I said, at its most intense, it wasn't really anything to write home about, but it was pretty much all those little sensations were pretty much wrapped up by. The 5 day mark. So you didn't feel, uh, you didn't have to take any pain medication.  I think maybe that first day, um, yeah, I might've taken like  a couple of ibuprofen, maybe like a Tylenol or something, but that was mostly just to kind of knock the edge off of it and kind of coast through it.

It wasn't, um, it wasn't like, I need Tylenol. I need ibuprofen. It was like, that would be nice. That would just take that little, that little hard edge off of it. Was it hard for you to pee right after the procedure? Did you have any difficulty? Um, kind of. It wasn't so much difficulty  as it is, you know, growing up with incontinence and not having any control of your bladder.

You're kind of used to Before your butt hits the seat, the P hits the water, you know what I mean? And so it was a very, very different for me to be sitting down and just kind of like, wow, where is it? You know, it's taking it a 2nd, you know, and he told me that that would, you know, it might take a 2nd or whatever so I wasn't nervous or anything, but I did, um. 

I did sit down and it did take just a second to be able to, like, I guess, figure out how to, like, really relax those muscles because they are kind of, you know, they're, they're done pretty tight.  Okay, so you go through this non procedure and now what what's happened to your symptoms?  It's  it's absolutely wild.

So, um, like I said, for the 1st, little bit, it kind of takes a 2nd to, like,  learn how to go to the restroom and, like, sit down and, like, relax enough to where, you know, you can kind of just get there.  But, uh, so the symptoms after the procedure were really kind of  non existent. Um, I went from, like, wearing a pad a day to, like, I don't wear pads anymore.

I don't buy them, which, for me, is a huge deal since literally having to wear them since middle school  for this issue. And so, um. It,  I'm not trying to sound dramatic, but it was very much a lifestyle changer for me. It was a game changer for me because, you know,  you want to go hiking. You want to go do things that cause you to kind of exert, you know, and in the past, it's just I held myself back so much just from the discomfort.

I know would follow. You know what I mean? So, um. Afterwards, it was pretty, as far as symptoms, I could cost knees, I picked up heavy things and not strained, but like, it took a little bit of effort and, um, it kind of occurred to me after I did a couple of things. I was just like, wow, before that would have been, I'd be having to deal with something right now.

And like, this is kind of.  I just feel free, freer in a way, you know what I mean? Do you feel better about yourself? Because I think there are a lot of, you know, self confidence and body image issues, even for the most self confident women when they're dealing with these issues.  For me, I would definitely say my self confidence has grown leaps and bounds.

You kind of don't realize the residual shame or something that you might be holding on to. Cause it's like, when I was younger, I was very embarrassed by it. As I get older, I was like, well, this clearly is not going anywhere and I don't know how to keep a secret. So I'm just not gonna, I'm not gonna like stay locked up about it.

But it's like, you know, there is that period of time where. There's just a lot of embarrassment and a lot of shame about it. And so what has really struck me now is that I,  that's something I didn't anticipate. Changing so much in addition to being able to do more or whatever, but the way that I felt as far as self confidence towards myself was like, I knew it was going to improve, but I didn't know that it was going to be 1 of the main things that I got out of this, uh, procedure.

So, all of the treatments that were discussed today, all work for stress incontinence and can all improve or cure stress incontinence.  So, one of the things that I think is so important for you to know is that there are lots of treatments for bladder leaking and there are lots of different things that you can do.

And I want to expose you to these treatments so you can pick the one that is right for you. So many women just live with incontinence and it dramatically impacts their life and they wish there was something they can do but they just don't know where to look. And this is to help you get started. So get out there and start getting dry.