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9. 15-Minute Consult: New Research in Vestibulodynia with Dr. Jill Krapf
132 Plays24 days ago
If you experience severe, sharp burning at the vaginal opening, you know how frustrating the journey to a clear diagnosis can be. In this episode, world-renowned pelvic pain expert Dr. Jill Krapf joins Dr. Rachel Pope to share a massive milestone in neuroinflammatory vulvar pain research: a gold-standard, 3-month clinical trial testing a brand-new topical Ketotifen cream.
Ketotifen is a mast cell stabilizer historically used for allergies, but it has never before been formulated into a topical cream for pelvic pain. This breakthrough treatment directly targets the "neuroinflammatory zone," calming hyper-reactive mast cells and hypersensitive nerve endings.
Key Takeaways:
- The Clinical Protocol: To track improvement, the trial uses two precise baseline tests: a specialized Q-Tip pressure monitor at the vestibule (requiring a 5/10 pain score to qualify) and a gentle dilator insertion test. Patient comfort is the absolute priority; tests stop immediately if pain thresholds are hit.
- A Pure Passion Project: Funding for localized vulvar pain is notoriously low. Backed by a small grant from the National Vulvodynia Association (NVA), this trial is a true labor of love by Dr. Krapf, Dr. Andrew Goldstein, and Dr. Chailee Moss to provide a non-surgical alternative for patients.
- How to Get Screened: Active trials are currently recruiting. Reach out directly to the site closest to you:
The Centers for Vulvovaginal Disorders Research Details & Locations:
- Duration: Approximately 3 months (only 4 short in-person study visits).
- Locations: Tampa (FL), Washington D.C., and New York City.
Tampa, (FL):
- Lichen Scelorus research: researchjkmd@gmail.com
Vulvodynia Research:
- Washington, DC- research.cvvd@gmail.com
- New York City, NY- research.cvvd@gmail.com
Exclusion Criteria: Individuals with active pudendal neuralgia or a diagnosed vulvar dermatosis (such as Lichen Sclerosus or Lichen Planus) are unfortunately excluded.
How to Get Screened: If you are interested in participating or traveling to one of the three sites, check the screening contacts listed. Even if you can't participate, sharing this study on social platforms helps show investors and pharmaceutical companies that women's health research is highly valued and desperately needs funding!
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Transcript
Introduction of Dr. Jill Kraft and Vulvar Conditions
00:00:00
Speaker
For my 15-minute consultation, i have world expert Dr. Jill Kraft here. She needs very little introduction. Those of you who follow Arwa Mandi already have heard her speak about vulvar dermatosis, about pelvic pain. You may have read the book that she helped write. There's so many amazing resources, and you know, Dr. Kraft is one of my go-to people when I have tough vestibulodynia. cases.
What is Vestibulodynia?
00:00:24
Speaker
So we are going to talk a little bit about not only vestibulodynia, but also like some of those refractory cases, some of those tough situations, and maybe just jump in. We could just jump in here. Like for anybody who's listening and doesn't yet have a diagnosis, we can talk about first, what is the diagnosis? What is vestibulodynia, Dr. Kraft?
00:00:44
Speaker
Yes. So I don't even like to think of vestibulodynia as a diagnosis. It's more describing where pain is located very specifically or how long it's been going on. Because, you know, going back to vulvodynia, which is a term that a lot of people have heard, it really just means an abnormal pain response of the vulva. for at least three months, so it's chronic. And then when we talk about vestibulodynia, we're just talking more specific. We're saying that the pain is
Complexities in Treating Vestibulodynia
00:01:13
Speaker
localized to the opening of the vagina or a specific part of the vulva that is within the labia minora and really bordered by the labia minora on the outside and the remnants of the hymeneal ring on the inside, kind of that just ring of discomfort that people describe, especially with dysprenia, which is our medical term for pain with intercourse, and we call it superficial dyspareunia when it's pain right at that opening area. So that's provoked vestibulodynia, which is the most common form that we likely see, at least that I see. Yeah, for sure. Me too. Just last week, I was kind of drawing a diagram out for a patient of like what
00:01:56
Speaker
you know, vestibulodynia, of course, we have pictures and diagrams to show them where the pain is and they're like, yep, that's it. And that's kind of what we just found on the exam, right? So it kind of resonates with them. But then I kind of break it into the different types of vestibulodynia or the etiologies, the causes, because I try to use that to explain to people like how we're going to then go through a little bit of trial and error, unfortunately, of treatment. And I say, unfortunately, because I wish that it were more streamlined, that I could say this is exactly why your vestibulodynia is here and this is the treatment that's going work for you. But can you
Interrelation of Muscles, Hormones, and Inflammation
00:02:29
Speaker
explain like why we're not there yet and what the differences are? Yes, it's so entangled, right? I mean, this area is a system. And when the system is not working optimally, then all parts of the system are really affected. In order to feel pain, there needs to be something going on with the nerves, right? Like that's that's what transmits the pain to our brain. so we acknowledge it as something that's painful. And so even if that's not the primary cause, there's always some sort of nerve involvement whenever we feel feel pain.
00:03:04
Speaker
And then, you know, when we're talking about our main bucket causes, we usually talk about hormone and muscle. But the issue is that if the muscles are tight, it's impeding blood flow. So it's limiting hormone within the bloodstream from getting to the glands that need the hormone to function. So whenever there's a tightness of the muscle or a hypertonic pelvic floor muscle dysfunction involved, we're usually going to see some sort of tissue effect or tissue breakdown because there is lack of oxygen, lack of hormone, lack of nutrients getting to that tissue. And then that process is going to lead to not only nerve irritation, but an inflammation sorts, which may have to do with mast cells, right? Which is a big hot topic right now. So I think that why we struggle with this is because all four of these buckets are typically related and we just have to figure out what's the driving factor. What's the thing
The Need for Neuroinflammatory Research
00:04:00
Speaker
that's more present than other things or what's the thing that's setting off the dominoes of the other potential causes that are present. And and that's why there's not typically a quick fix or a one medication that's going to really help this condition. It really needs to be a multimodal approach. We need to really address the hormonal component and the muscular component and the nerve component and the inflammatory component altogether. Yeah, exactly. That makes a lot of sense. And so you mentioned mast cell activation, and I feel like that is an area where we need the most discovery around. And Where, I mean, even as as I'm trying to learn, I'm realizing there's so much that I don't know and so much that we collectively as a scientific body don't know, right There's so much more that we have to understand about this and also explains why some patients don't get better. Exactly. and you know, it comes down to genetics, like everything else is what we're finding, right? It depends on how our body is able to process certain things or what our immune response is locally, or how our body deals with irritants and allergens and You know, there's just so many components involved in this. And I don't have all the answers when it comes to mat cell disorders because nobody has all the answers.
00:05:21
Speaker
um We're really, this is the forefront. We're figuring this out. But what we can say is that there seems to be a connection. There seems to be a connection between these different conditions, between mast cell activation spectrum or however wanna term it and connective tissue disorders and POTS if you will and vulvodynia, vestibulodynia, endometriosis and then with gut, with the GI system. And
Research and Publications on Vulvodynia
00:05:51
Speaker
it's definitely not separate silos, right? There's a common denominator here with how our body reacts to different challenges. And that's the common denominator, whether it be related to the genetics of our connective tissue, the genetics of our histamine response or mast cell response to different challenges. And so we're just starting to put all of this together. But I think the first step is to recognize that, yes, there actually is a connection here. Yeah, exactly. and I mean, i talk all the time about how much more research we need, but you're doing some of that research. Can you tell us about it? Yes. So we're actually about to publish a paper looking at all the intricacies in in these connections with vulvodynia. So that paper is coming out soon, and I'm happy to talk about it once it's once it's published.
00:06:40
Speaker
We're also actively doing research. So what's really interesting is we held... a big summit, the vulvodynia research summit a couple years ago. The findings from that summit were published in February in the Green Journal. And
Advancements in Treatments for Vulvodynia
00:06:54
Speaker
the idea here is that we were recognizing that, okay, when it comes to muscle driven causes of visibulodynia, we're really on top of that. That's in the guidelines where, you know, we're very vocal about pelvic floor physiotherapy and the benefits of that from a pelvic standpoint. And we're getting much, much better at the hormonal treatments for these. We know with GSM that it's very um important that we restore locally in a low-dose fashion estradiol. And then testosterone is really is really coming out as the next frontier for this area. We have DHEA, suppository medications. So we're we're making headway when it comes to muscle and when it comes to hormone. Where we're stuck is neuroinflammatory.
00:07:40
Speaker
So if it's an inflammatory cause, like a vulvar dermatosis, yes, we're getting a little more awareness out there. And there's, there's treatment options for those things like lichen sclerosis and lichen planus. But when it's not those things, then it becomes really tricky. And The inflammatory area has always been, least for me, kind of like this black box of, oh my gosh, what do we do? You know, we can identify that it's related to disquemative inflammatory vaginitis or some other condition that we're better recognizing,
Vulvodynia Summit and Global Expert Engagement
00:08:09
Speaker
fine, but what if it isn't? Then what is it, right? We've always struggled with that part. And the research that has been in this area super old as far as the available therapies that we've had in the past that really aren't done clinically. And then the last grouping is really that neuroproliferative. Now, when it comes to pudendal neuralgia and genetopelvic neuralgia, again, that's another frontier and we're getting a little bit better with that area, a little bit. But when it comes to neuroproliferative, really the mainstay of treatment that we've always had has been vestibulectomy, which is surgery that's gotten a lot of interest lately. There's a film that was on it called The Lady Parts, which is an excellent film. I have not seen it yet. I need to see it. you have to see it. I've never seen it. It's so good. But for a long time, we really just had surgery as an option for these refractory patients that we could not treat with conservative measures or topical measures. It was really surgery that's hard to access, resource intensive, and long recovery time. And then patients often need rehabilitation from a muscle standpoint afterwards, of course, and those expectations should be set. But it's like, you know, what do you do? Like these are not like easy options. And so the vulvodynia summit really came forward to really figure out, okay, when we're in that nerve ending area, when we're in that inflammatory area where it's not due to the things that we recognize, that neuroinflammatory zone, what research needs to be done for this? And how can we pull in people that may not be in the field, but may have potential therapies that they didn't even know could work for vestibulodynia. And so that's how that came together. And we met, it was a global initiative. We met in the Washington, DC area, and we identified number of treatment options. The top six
Study on Catatophan for Vestibulodynia
00:09:58
Speaker
are highlighted the article. And the top option that was determined is catatophen. And cototaphin is really interesting because it's a pretty old medication. It's a mast cell stabilizer. It obviously has effect on cells, but it could have effect from a nerve standpoint too. We just don't know. it's historically been available in a pill form. Typically for asthma, it's been available in an eye drop form for allergy related eye conditions. Yeah.
00:10:27
Speaker
But it's never been made into a topical, not even kind of like off on the side. And and so the study that we're conducting right now, it's a randomized control trial looking at topical catatophan to see if there's utility. We know it's fairly safe. We are testing to see if there's a base reaction before patients try the actual study medication, because we're aware that that can be ah a factor, especially in populations that may have this. But it's a really well-designed study. It's randomized control study, blinded, so we don't know who's getting what. But it's for patients that have what we call secondary neuroproliferative vestibulodynia. So basically, vestibulodynia, so pain at each point at the vestibule that is present
00:11:12
Speaker
that wasn't always present. So somebody who had been able to insert a tampon in the past, who maybe had been able to insert, you know, something, have intercourse, what have you, and then something happened, and now there's pain in that area. So not primary congenital, we're talking about secondary vestibulodynia for this one. and Yeah, that's basically what we're looking for adults with secondary provoked vestibulodynia. There's four study visits, so it's not labor
Criteria and Methods of the Catatophan Study
00:11:41
Speaker
intensive. We're currently running the trials in three cities in Tampa, Florida, in Washington, D.C., and in New York City. Nice. Okay, that covers a lot of ground. Yeah. And are there any exclusion criteria, things where people would not be eligible to participate?
00:11:59
Speaker
Yes, so we do and we do check for pudendal neuralgia. So if someone has documented pudendal neuralgia, unfortunately, they can't participate. If they have vulvar dermatosis, like in sclerosis or in plainest. But otherwise, you know as long as they're on stable regimens um for treatment, we do do pre-screening, so you don't have to worry far as someone coming in. We have a research assistant who screens everybody before we even bring them in to make sure that we're not wasting anyone's time or energy. And then, yeah, if somebody qualifies, then it just it depends on we use a pressure monitor. the q-tip swab to to check the different points of the vestibule. And as long as there's greater than ah five out of 10 pain in that area, and then the other outcome measure is a dilator test. So they have to have some sort of pain with dilator insertion, even a small one. And if there's a pain over a certain threshold, we don't continue. We only go to
Impact of Patient Participation in Research
00:12:53
Speaker
that level. And then that's it. That's all that's needed. And we're looking for change, obviously, in our outcome measures. So pain with
00:13:00
Speaker
touch with a Q-tip swab, as well as the dilator test to see if there's changes. And how long does the trial last? If someone is participating, how long will they to? Yeah, it's ah about three months.
00:13:12
Speaker
Pretty standard. And it's it's ah it's a really nice study. And we really thank the National Vulvodynia Association because they provided funding to conduct this study. Funding, as you know, is always an issue in this area of research. And so it's a very small grant that we were given. So this is really a passion project for Dr. Andrew Goldstein, myself and Dr. Kylie Moss. We're the the three PIs at each site. And it's really more of a passion project because we really want to see if this is an option for patients, especially when other things are not working or to more likely use in conjunction with the treatment options that we already have.
00:13:48
Speaker
That's fantastic. I mean, the three of you are leaders in our field and I love seeing what you're doing and, and you guys are always teaching and speaking. And I mean, i feel like all of your projects are passion projects and that's so wonderful and so helpful for all the women out there who have Loma Dynia or provoked vestibulodynia, especially because there's just so much trial and error. And I know how frustrating it is for them to have to go through One after the other thing. And then like there are times where I'm like, I'm not sure what else to offer you because we've tried literally everything that I'm aware of. And it's really important that we have more.
00:14:26
Speaker
option I agree. And I think that when we're thinking that something might have utility, it's so important to study it it. really is. Because, you know, and it's not uncommon that in our field, there's going to be a lot of experimental treatments. That's just the name of the game. Because, you know, a lot of these things are not well established. We're learning about the different, and even the causes or associated factors of the stibulodynia is really not that old. the last nomenclature document is about 10 years old, 11 years old at this point, right? And it probably needs to be updated in the near future. So, you know, this is all evolving. And I think that when we have a therapy that could work, it's really important to do quality research. to determine if this is a viable option for people. And so, you know, I'm really excited about this study. and the other thing is that when we show up for studies like this, when patients show up, it sends the message that these conditions are valued, that they're important, and it's going to promote
00:15:31
Speaker
further research and more research funding. Because when we
Encouragement to Share Study Information
00:15:36
Speaker
have a study like this, and we open it up and say, okay, we need participants, and then people come out, you know, people, investors, and people that are providing funding and organizations and potentially pharmaceutical companies, they're looking, they're watching. And when they see, oh wow, this had a high recruitment, like people care about this, there's interest in this, it's only going to promote more innovation in this area of study in this condition. and so I think that, you know, even if somebody can't participate, because they're located somewhere else, and they can't make that trip, which is completely understandable, it's so important to share with your network to share, you know, in your own way, even if you share with somebody, a friend, or ah on a support group, or on social or on Reddit or what have you, because it just gets to that one person who may be located in that area that feels out of options and would like to try something like this to advance the science here, because that's what we really need. I know it's hard. It's really hard sell to get people to come to Cleveland for the stuff that I do. But for what you guys are doing in New York, DC and Tampa, I mean, those are all very reasonable places to go visit and and make a trip of it.
00:16:45
Speaker
Absolutely. yeah So I mean, if if we can, you know, spread the word, reach out, even awareness is important. Just by talking about this, it raises awareness. And hopefully we can come up with more innovative approaches for treatment because they are needed.
00:17:03
Speaker
yeah Well, I really appreciate you taking the time. Thank you for the 15-minute consult. And I will be sending you people. And I'm sure if if anybody is out there listening and feels like they know would qualify for this or benefit from it, I'll put the information in the show notes so that they can reach out and get screened. That sounds wonderful. I'll give you those email addresses for the different sites. Awesome.