Innovating Women's Health: The Story Behind Yoni Fit

In this episode, Allison Watkins joins the podcast to discuss Yoni Fit, an innovative incontinence pessary she developed. Watkins shares her personal experiences with stress urinary incontinence following childbirth, leading her to create Yoni Fit as a solution. She talks about the challenges she faced, including unsuccessful pelvic floor rehabilitation, and how her active lifestyle inspired the design of her device. The conversation covers the practical aspects of using Yoni Fit, the importance of self-sizing for comfort and efficacy, and the prospects of making the product available through pharmacies and telehealth. This episode emphasizes how important it is to handle incontinence problems tactfully and successfully.  

For more information, be sure to check out her 

website at: https://yonifit.com/

Instagram: @yoni.fit_bladder_support

Facebook: Yōni.Fit Bladder Support

Timeline:

00:28 Introduction to the Podcast and Guest 

00:52 Allison's Personal Journey with Incontinence 

02:08 Challenges and Initial Solutions 

03:17 The Birth of Yoni Fit 

05:46 Development and Testing of Yoni Fit 

08:26 Efficacy and Comfort of Yoni Fit 

15:18 Target Audience and Availability 

18:52 Conclusion and Final Thoughts

Transcript

 Hi there. I'm here today with Allison Watkins who developed the Yoni Fit, which is an incontinence pessary. Um, and this whole device kind of developed with from her own story with incontinence  and Allison, I'm, I'm wondering if you can just tell me what you experienced at the beginning after your deliveries. 

Yes. So thank you so much. Thanks for having me on the podcast. I, um, you know, I had a baby whenever I was 29, that was my first child and he was large, but not huge. And I did experience, um, you know, some stress urinary incontinence whenever I would go to the gym, but I didn't realize that it was chronic and I didn't realize that, you know, it would get worse.

I just kind of let You know, modified my behavior stopped working out as much started gaining way and then experienced worse stress incontinence and then had another baby who is amazing and beautiful, wonderful gift, but she was 11 pounds a day. She was born. So after her birth, it felt really debilitating.

Specifically on the mental health side, I think, because my incontinence was so bad. Um, and so then that's when I really just poured over how to fix my own issue and, um, started working on developing Yoni Fit bladder supports.  

Um, I, I think that is such a common story. And I, I think when you have young kids, right, you're frequently just trying to get by, right?

Those babies take up all of your time. And, you know, when these things happen to you, it's hard to find the time.  Um, and the space to address it. Did you talk to any providers about it?  

I did. I, um, actually did pelvic floor rehabilitation. So for me, it was a big expense at the time and not only financial, but time.

Um, as you just stated, right, to echo your point, it was, uh, quite a commitment and it was, you know, for me, I know that technology has come a long way, I think since I tried it and did it, but for me, it was not successful. Um, and so that was just kind of added, I think, to the disappointment of the whole situation.

Yeah, it, it works for a lot of people. It definitely does not work for everyone. And it is. Um, slow progress, right? I mean, you have to do public floor physical therapy for six to 12 weeks to see a benefit. And that can be really difficult, right? When you're busy doing a lot of things, it's, it's, it can be hard to keep going.

And depending on where you are, I mean, some people have to travel a really long time, a really long distance to get to physical therapy.  Um, and, and that, you know, the, the time and the expense just makes it that much more difficult. 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 whenever 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. a larger tampon, but I also didn't have as much you're in 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 some people will even wear it. 

Um, when they're not menstruating to help with the leaking, um, did you try a traditional incontinence pessary? Was that offered to you? 

That was never offered to me. No. 

Okay. Did you know that they existed? 

I found them online.  Okay, but then 

you decided to invent your own.  

Well, yeah, I mean, I 

happen 

to doctors about it.

Well, I mean, even just the, the, what I was reading online was talking about prolapse and it was showing them, you know, in the body. And so I didn't.  I don't think I have, I mean, maybe I have mild prolapse, but I really don't think I have prolapse. I was 

never, I mean, there are some traditional pessaries that are made just for leaking.

Um,  I mean, we do tend to use pessaries more frequently for prolapse, but there are some that are available for incontinence, but that wasn't something that you were exposed to, so you went on your own pessary adventure.  So how did you do that?  

So, you know, I mean, what I did actually was I started buying all of the things like, you know, cause I did the, the electronic stimulation device or biofeedback device.

That was my pelvic floor  rehab. And then I started to buy the weighted, like Kegel devices and try to figure out how to do that on my own. So I had already spent all this money on these vaginal inserts and, you know.  So I drew a picture basically of, you know, the first variation of Yoni fit. And then I hired a woman to pull it up and get, draw it up in CAD.

Um, so I just met with her and I had done a little research on, you know, materials and things of that nature. There are some things like out of the UK, there's like this hard, um, and then there's the, um, your rest device. So that's. Sort of similar to what I was thinking about more than like the pessary that, um, like the traditional pessary for pelvic organ prolapse.

Yeah. So the, your rest is another incontinence device that's available over the counter in Canada  and is available right now by prescription in the United States.  So, so you had it drawn up and then you figured out what material you wanted it to be made of. And what did you choose? Did you choose silicone?

Yes, it's 100 percent medical grade silicone. It's really soft and flexible. So I did try the arrest and for me, it was like yoga and a lot of movement. It was just hard and rigid and uncomfortable. So it felt like it was poking on my organs a little bit. So that's  where I started thinking about a softer, more flexible, um, silicone that could collapse and expand once inserted to sort of fit the shape of my body.

Um, and then we recognized. That we did a feasibility study at the University of Oklahoma Health Sciences Center with just 2 2 devices and recognized from that study that we would need to make some variations to like the removal tab, but also create different sizes outside of just the 2. So now we have 6 sizes of the device.

How so in that feasibility study, I mean, you just had women try it and then comment on it. How did that work? No, it 

was actually, um, you know, we had women,  we had them drink a liter of water in the clinic,  had them do a series of activities first without the device and then with the device in place, but we, we alternated.

So half of the patients Had the device in place first half of the, uh, patients had the device in place at the second half of, of the test. Um, and we did a pad weight test and it was actually efficacious. We had, um, like a 73%, I think, efficacy, um, in reduction of pad weight from that, um, feasibility study.

But we did recognize that we were gonna have to do some more work to really perfect the device.  

Okay. 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 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  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 

And then they came back to the doctor and, um, the physician then verified that they chose the right size.  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 two 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. Yeah. The, 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 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 right size and 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 1 to pick.

So, for those patients, we have created a sizing chart that the physician just does an exam and mid vagina with 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 2 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. Okay. And 

this is a prescription device, correct? 

Correct. Okay. Okay. 

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, but on the self sizing and everything it is, there's just so much information to keep it simple for both the providers.  That is 

really 

nice. 

Um, what about comfort? Because, I mean, you're, you're right. I, I like the Uresta, but the Uresta is very rigid and some patients find it uncomfortable. Um, what kind of feedback are you getting?  

So discomfort was really, we had Two adverse events that were the most common and it was a little spotting and discomfort that was in the first kind of week, mainly of the fitting phase.

So until you get the right fit, it's not going to be comfortable. Once you get the right fit, you shouldn't really even be able to feel it.  If it's too small, it's going to recede a little bit and you might feel that tab. That's going to be uncomfortable. You also are going to still experience some leaking. 

If it's large enough, it should place enough pressure internally to where you don't feel it. You don't feel the tab and it's preventing the involuntary leaking.  The postmenopausal demographic were really the patients that experienced the most spotting and discomfort. And so we are thinking forward, you know, to develop devices specifically for that patient that may have like a lubricant or a hormone, you know, top of the form.

Um, So for now we are targeting sort of that sexually active still, um, menstruating patient. Um, but that's not to say that we're completely, we, you know, think that it's not going to work for any patient that's postmenopausal. We just want it to be right as well for that patient. 

Yeah. Uh, there are definitely tissue differences, right.

And someone who's postmenopausal  and other things to consider. So it, it, you know, premenopausal may be a little bit more straightforward at the beginning. Um, and so that makes sense to me. So who is your ideal patient? Like, who are you targeting with this?  

So we're really targeting women like around the age of 25 to 54. 

So we're initially sort of speaking, I think, mostly to the OBGYNs because a lot of women experience this right after they have babies. And so we think that that's kind of where maybe we can start with the patients, start having the conversations so that it doesn't go so long that they're waiting that seven years, you know, to go to the urogynecologist.

And it's so much worse.  

Well, and it's nice that they can do so much of this on their own, right, since that is a point in life when you have so very little time. 

I was going to say, and if they want to have more babies, you know, it may not make sense to have surgery. 

I mean, that's definitely true. If someone's going to have more kids, we definitely do.

you know, prefer to not operate. Uh, there are always some instances where we'll consider it, but in general, you know, if you're going to have more children, um, it's, it's best to do that first before we consider a surgery for incontinence just because the surgery, um, and, you know, even just the pregnancy, much less the delivery can impact how well that surgery works. 

Um, so this is a new device. Um, where is it available? I mean, if I'm a new mom and I'm having  incontinence and, you know, this sounds like the best thing ever to me, what do I do?  

So you need to talk to your doctor about it. So we do have a website, yoni fit. com. If your doctor has not heard of us, you can show them, you can actually even show them the provider instructions for prescribing.

There's a link in there. Um, or, you know, we're, we're sending out VIP kits to prescribers and we will be in a national distribution chain. Our target is November 1st. That's seven days. Oh my gosh.  Congratulations.  Thank you. So we're really excited about that. And I think that's really going to ease, you know, access for everybody.

And then I think that'll really open up this telehealth um, opportunity as well for providers, especially like I'm thinking during the holidays,  that might be a really good time to, um, launch the telehealth side. 

So, you know, right now, I mean, that's actually a good question for me as a provider. I mean, right now I have pastries in my office, but in this option, I wouldn't actually have to have them physically in the office, right?

We would just write the prescription and then the patient would get it through the company. 

That's right. Well, not through the company. It has to go through a pharmacy, but yeah, pharmacy. 

Yeah. Okay. 

Um, so, but we do want to provide the kits for any physician that wants to show it to their patient, because as we've mentioned, you know, some patients just are not going to be comfortable with a vaginal insert and that's okay.

So, you know, we don't want to waste people's time if, if that looks intimidating, but the beauty of it as a provider is that you don't have to actually insert it in the office and then worry about sterilization and. having the patient urinate and walk around and maybe have to come back for multiple fittings.

Um, I, I think that's actually a brilliant idea because showing the patient, I mean, a lot of patients will be interested in pessary and then once you show them the pessary, um, the people who aren't interested in it, it, it becomes very clear, right? I mean, just looking at it, they know whether it's an option or not for them.

Um, and you know, it's just interesting what.  I mean, everybody's comfort level is just a little bit different. Um, okay. So I, I think this is an amazing device. I'm, I'm always so impressed by people who have a problem and then create a solution rather than just kind of accepting what is currently available.

Um, I, I think you have done just such a great job with this. I, you know, one of the things that I really like about it is, I think your marketing and the way that it is packaged is. Um, really pretty.  

Thank you.  

And, you know, 

dignity  to an undignified situation. Well, 

exactly. That's exactly what I was going to say.

I mean, I think that sounds like such a small thing, but it's not a small thing for a lot of women, right? Receiving something that, you know, looks attractive and restores a level of dignity, just like you said, um,  really just. You know, makes the condition of incontinence so much easier for women to tolerate.

So thank you for considering, you know, those, those soft aspects as well.  

Well, thank you so much for your important work. You know, we need more of you. There just frankly are not a lot of experts. Spurts out there and incontinence, there are not enough. 

That is definitely true. And it's funny because it's something that nobody wants to talk about, right?

Even providers aren't comfortable talking about it, and it's such an important quality of life issue for so many, so many people. I mean, I only treat women, but you know men as well. Yeah,  

absolutely. 

Yeah. So, uh, I just wanna thank you for your time and your great work, and I can't wait to see what you do next.

Thank you. Thank you so much for having me on the podcast. I appreciate it. 

Of course.





Innovating Women's Health: The Story Behind Yoni Fit