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BackTable / OBGYN / Podcast / Transcript #33
Podcast Transcript: Genitourinary Syndrome of Menopause (GSM): Improving a DRY Topic
with Dr. Rachel Rubin
This week on BackTable OBGYN, Dr. Suzette Sutherland and Dr. Rachel Rubin discuss the diagnosis and treatment of genitourinary syndrome of menopause (GSM) with vaginal estrogen. You can read the full transcript below and listen to this episode here on BackTable.com.
Table of Contents
(1) Defining Genitourinary Syndrome of Menopause (GSM)
(2) Products for Local Vaginal Supplementation
(3) The Role of Hormones in Decreasing Recurrent Vaginal & Urinary Infections
(4) Vaginal Suppositories
(5) Debunking Myths About the Use of Vaginal Estrogen
(6) Vaginal Estrogen in Patients on Systemic Hormone Therapy
(7) Vaginal Estrogen in Patients with a History of Cancer
(8) Genitourinary Issues in Premenopausal Patients
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[Dr. Suzette Sutherland]
Welcome, everyone. I'm Suzette Sutherland, your host of this episode. I'm a female urologist in Seattle at the University of Washington, and I have with me here today Dr. Rachel Rubin, who's a urologist and sexual medicine specialist in the Washington, D.C. area. Her academic affiliation is with Georgetown. She did her medical training at Tufts, then her urology training at Georgetown, and then a sexual medicine fellowship with the infamous Irwin Goldstein in San Diego. Since then, she's gone out on her own and started her own private practice, which is really specializing in sexual medicine, both for women and men so very excited to have her here today. Welcome, Rachel.
[Dr. Rachel Rubin]
Thank you so much for having me. This is just an honor. I've been looking forward to this.
(1) Defining Genitourinary Syndrome of Menopause (GSM)
[Dr. Suzette Sutherland]
Our topic today is a hot topic. We're talking about genitourinary syndrome of menopause, or also known as GSM. We hear a lot about this in the media, in our academic circles today, but unfortunately, we don't have a lot of information about it that's used readily for a lot of urologists and gynecologists. Rachel is doing a lot of work in this area, and that's what she's here to talk to us about today. Just to start off, can you actually simply define for us what is GSM and how is it primarily affected?
[Dr. Rachel Rubin]
Yes. No, thank you so much, because this is a topic that is near and dear to my heart. GSM, as you said, stands for genitourinary syndrome of menopause so genitals, but also urinary. It's a urologic condition. Now, we got this name in 2014 when a group of people sat in a room and decided that vaginal atrophy wasn't a very nice term. Not only is it not nice to tell a woman her vagina is atrophic, but it really doesn't describe what's actually happening to the tissue when it doesn't have the hormones that it so badly requires.
Now, this is a urologic problem, right? The urethra, the bladder, the vulva, it all requires hormones to stay acidic and to maintain a healthy microbiome and so it's not just vaginal atrophy, but it's the signs and symptoms that we see when there are no longer hormones in the tissue. The hormones are not just an estrogen story, but actually an androgen story as well. The symptoms can be, yes, vaginal dryness, yes, irritation of the vulva, but it can be itching, burning, dysuria, urinary frequency and urgency, bladder pain, which we all see quite frequently, and recurrent urinary tract infections, which we know can kill people. This isn't just a little vaginal dryness or a little vulvar atrophy. This is recurrent urinary tract infections, which are very dangerous for our patients.
[Dr. Suzette Sutherland]
That's great. Thank you for being so thorough with that. So many people really do think, well, it's just about my vaginal tissue, and if I'm not sexually active, then why do I need to replenish that vaginal tissue? But you just nicely pointed out many other areas that help with the health of the vaginal as well as the urinary system, recurrent UTIs, just localized burning, even urinary incontinence. It can help with some stress incontinence and certainly overactive bladder and urge incontinence. So it's not just about sex. Women think if I'm not sexually active, I don't need to use any vaginal supplementation, but that's just not true. There's so many wonderful benefits. While we're on that part of it, can you mention just simply what are some of the main products that are out there that are used for small dose local vaginal supplementation today and how do you use them appropriately?
(2) Products for Local Vaginal Supplementation
[Dr. Rachel Rubin]
This is also something that we need to train urologists that we have some updated tools in our toolbox, right? We've had products since the 1970s. Premarin was the first to the market but since then, we have many more tools in our toolbox and I want to urge doctors to sometimes move away from things like Premarin. The reason is a lot of women don't like goopy creams in their vaginas. It can leak out, mess up their sheets and underwear, but also, Premarin is made from pregnant horse urine, which has some issues with animal cruelty and there's also some chemicals within it that can be irritating or burning.
Now, that being said, if it's the only product available to your patients, it's the best product available, but often, it's not even the cheapest product available. We have estradiol creams, that's your Estrace creams, which you can get on GoodRx or Mark Cuban's pharmacy for $20 a tube, which can last two and a half months. We also have generic estradiol inserts that are 10 micrograms that are fabulous to use every day for two weeks and then twice a week forever. We have branded vaginal estradiol inserts, so they're called Invexi. We have Intrarosa, which is vaginal DHEA, which is a nightly suppository that is fabulous because it's the only FDA-proof product that has androgen. DHEA is an androgen, which is really great. We also have vaginal rings. The ESTRING is a slowly producing estrogen ring that stays in for three months at a time. Now, those are the local therapies. There is one oral therapy called Ospemiphene, which has more systemic properties, and so I tend to use more of the local therapies, but it's approved and quite effective for genitourinary syndrome of menopause.
[Dr. Suzette Sutherland]
Great. You mentioned already some, too, that aren't specific estrogen supplementation, but of course, the downstream effect is still the same. Can you explain that a little bit more, go into detail how the DHEA and the SERMs, how that actually is beneficial in the estrogen side of things?
[Dr. Rachel Rubin]
Yes, I'll start with the DHEA. Now, this product is called Intrarosa. It's a once-nightly vaginal suppository. There's two ingredients, palm oil, and DHEAs, so there's not a lot of stuff in it. It comes with applicators that do get thrown away and they don't have to be reused. It's really important to know that the urethra, the bladder, the vulvar, and the vulvar vestibule tissue has lots of testosterone receptors in it, not just estrogen receptors, but testosterone receptors as well. Often that estrogen-only is often enough, but sometimes it's not. Sometimes that tissue at the opening of the vulva or the urethra is still irritated. What research is finding is that there is a lot of androgen story that we're not talking about because we don't have a lot of products. Well, DHEA is an FDA-approved product that adds androgen locally. The way it works is once you put it in, the body's own enzymes take the DHEA and turn it into both estrogen and testosterone. We presented data at the AUA this year, which won an award, which was very exciting, but that showed that you can decrease urinary tract infections by up to half. This goes into women in their 70s, 80s, and so on. Vaginal estrogen does that as well. It also reduces urinary tract infections and so this is a real preventative strategy that you can give to women.
We also have data that DHEA helps with urinary urgency and urinary frequency and so it's really a lovely product that I see is in your toolbox. Now, often first line is vaginal estrogen because it's often more affordable and better covered by insurance, but we certainly do get prior authorizations for our DHEA and they sample quite well. In terms of the aspemiphene or the CIRM, CIRMs like Tamoxifen is a CIRM, raloxifene is a CIRM. Well, aspemiphene is a CIRM that acts quite well on the vulvar tissue and so there are possibilities of other systemic effects. There is a very small risk of blood clots and things like that. In my older, older patients, I tend to stay away from that product. However, if you have a patient who really does not want to put anything vaginally, we all know we have those patients who it is a barrier. Aspemiphene can be a very great choice.
[Dr. Suzette Sutherland]
You mentioned again, to go back a little bit to the DHEA, people also used to use it orally, but doing that a little bit more, I think for desire issues. Is there also a rule that helps replenish the vaginal tissue if you take it orally?
[Dr. Rachel Rubin]
Yes, we don't have any data to support oral use for vaginal health and unfortunately, oral DHEA hasn't panned out as being this perfect treatment for libido that we all hoped it would be. I think the data kind of shows, well, it doesn't seem to hurt people, but it also doesn't seem to do that much and we have other lovely tools for low desire in our toolbox that are FDA-approved or using actual testosterone, which can be quite useful for low libido. The data putting it vaginally is quite robust and it really shows really incredible results. In fact, literally just this week in the Journal of Sexual Medicine, there is an article from my mentor, Erwin Goldstein's group, that showed using vaginal DHEA actually improves the tissue at the vulvar vestibule. So, putting something intravaginally heals the tissue surrounding the urethra at the opening of the vulva, which, as we know, is why most women have pain with intercourse. It's that vulvar vestibule tissue, which, in fact, is urologic anatomy. It's all endodermal urethra tissue. It's the same as the male urethra, which is tubularized and swimming in lots of testosterone.
[Dr. Suzette Sutherland]
You also said something that sparked something for me I wanted you to go into a little more detail because I think as urologists, the word is out there now a little bit that estrogen can help in these patients that have recurrent UTIs, but people don't always understand why that is and don't understand how important that is. I know in my environment, even our infectious disease providers, that's the first thing they ask. Are they on some vaginal estrogen? Can you explain why is that beneficial for recurrent UTIs and vaginal infections?
(3) The Role of Hormones in Decreasing Recurrent Vaginal & Urinary Infections
[Dr. Rachel Rubin]
I wish I could replicate your infectious disease doctors because I wish more people understood how important the vaginal microbiome is to prevent urinary tract infection. The vagina would like to be a very acidic place with lots of lactobacilli supporting the tissue health so that it lubricates, that it's stretchy, that it's an acidic environment so that bad bacteria cannot grow. As we get older and we lose hormones in our body, now that's both estrogen and testosterone, and that can happen even before your periods stop, the tissue can change. Well, the tissue gets thin, it gets raw, it gets irritated, it loses acidity so that pH actually changes. I test this in my office, it's really fabulous. You can actually tell when the pH changes, the symptoms worsen and the microbiome changes and gets worse. You can grow E. coli, you can grow other bacteria that really will increase your risk of a urinary tract infection. Then you add sex or penetration, which is a contact sport. A lot of the outsides coming into the inside, but the problem is you get all of this change in the microbiome. The urethra is only four centimeters long or four, I don't know, how long? You're the urogynecologist. How long is the urethra?
[Dr. Suzette Sutherland]
About three centimeters.
[Dr. Rachel Rubin]
Three centimeters. All right. See, I was a little off, so it's very short and bacteria can kind of go in there and increase your risk of urinary tract infection. Vaginal hormones, either estrogen or DHEA, are there to bulk up the tissue to keep it acidic, keep that pH four and a half, to keep those lactobacilli growing, and so then when you have penetration or if you're just wearing tight yoga pants, the tissue doesn't increase your likelihood of getting a urinary tract infection. We can't prevent all UTIs, but man, we can prevent a lot of them.
[Dr. Suzette Sutherland]
Yes, those are great day-to-day examples too. Thank you for those. Let's move over into, there's this myth about the proper way to use the estrogen. You mentioned a little bit, especially when we're talking about creams, that seems to be the thing that's most widely used. I don't know if it's mostly due to insurance issues today, but estrogen cream. I hear people who come from other providers and they say, they told me to do a little pea size on the tip of my finger and I use it once to maybe twice a week or a little dab. Can you please speak to that? Debunk the myth and why.
[Dr. Rachel Rubin]
Let's debunk this myth and this is where Dr. Sutherland and I could scream from every rooftop available because it is not enough that you recommend these products to your patients. You must sell them. We as doctors are salespeople. You all are incredible. You sell your patients on urodynamics. Let me stick these tubes in your holes and test pressures. You sell your patients on InterStim. Let me put these leads into your spine and make you bionic. You sell people on prostatectomies. Hey, likelihood you'll have erectile dysfunction, but we're going to save you-- You sell patients every day. The problem is vaginal hormones in your mind are so easy that you forget to sell it.
You forget to explain why it's important and that's the whole story there. It's not that you don't know it's important and you don't know how to do it, but you're not getting it through to the patient that it's safe, that it's effective, and that it's actually probably the most important tool in their foundational bladder support. So I think that even if you give them the cream or the inserts, if you don't explain why, if you don't explain that it's used forever, and if you don't combat it with, hey, the box says some pretty egregious things that are not true, you're going to fail in this adventure of helping patients prevent urinary tract infections, and then you're going to call them non-compliant. I would argue it's not that they're non-compliant, it's that you're not a good salesperson. That little dab of estrogen on the urethra, it's not enough. You can't prove to me that it acidifies the vagina completely and fixes the microbiome. By telling patients to only use a dab, you are literally telling them any more might be dangerous, which is not true. So if you're going to use creams, it's okay to take a dab and put it on the urethra and put it at that vulvar vestibule, vulvar opening. That's great, but you've got to take at least a gram of this stuff. You could probably get away with half a gram, but let's say a gram every day for two weeks and then twice a week till death do you part.
Now if you're going to use creams, one hack that we use is take a gram and put it out on your finger so you don't have to reuse the applicator and rub it into the tissue, just like you're rubbing in sunscreen on your face, because women do not like how messy and goopy this cream can be. If your patient doesn't like the creams, be quick to pivot to a tablet insert like an Estradiol 10-microgram tablet that goes in every day for two weeks and then twice a week till death does she part, or the DHEA that goes in every night till death does she part, or the ring for your dementia or poor dexterity patients that goes in for three months at a time. So you have tools, but you have to make sure patients are actually using this stuff. I get pH paper in my office, and we can test that the pH is actually four and a half and I tell you, my after-hours and weekend phone does not ring with UTIs, every now and then but really, I'm not a UTI clinic.
(4) Vaginal Suppositories
[Dr. Suzette Sutherland]
What's your experience with the suppositories? There are two that are on the market, the Vagifem, the Uvifem, are the estrogen suppositories. You also mentioned the Imvexi, but when I prescribe the Vagifem, you already mentioned it's 10 micrograms. It used to be 25 micrograms, and then they brought it down to 10 micrograms. What I find is oftentimes three times a week is really necessary to keep the woman where she needs to be. Do you have that same experience?
[Dr. Rachel Rubin]
Yes. Again, I'm not afraid of it, right? I think this is really the misnomers is so many people are messaging me on Instagram, Dr. Rubin, I'm perimenopausal. Is it safe for me to use this? Dr. Rubin, I'm breastfeeding, is it safe for me to use this? You sit there and you think, wait a minute. When you're breastfeeding, people give you birth control pills, which is like a nuclear bomb amount of hormones. Of course, a 10-microgram insert is totally safe for you to use. If you're perimenopausal, your own estrogen levels can get up to 600. Of course, it's okay to use 10 micrograms of estrogen and so, yes, I think three times a week is totally within reasonable limits.
Again, the worry is if you get very high with estrogen, which you don't with a 10-microgram insert, it's like the equivalent of 1 milligram per year of estrogen in your body. Whereas if I'm giving oral estrogen, which I hardly ever do, I usually do transdermal, but we give 2 milligrams a day of estrogen, right? It really becomes understanding the dose. This is such a low dose. If you wanted to use the insert, but you wanted to have them rub some cream on the opening, that's safe too, right? There's ways around it. Say they have some urethral or vestibule symptoms, well, you can do two things so that you don't have to do all creams. It's $20 a tube. That's kind of some of the workarounds that I use.
[Dr. Suzette Sutherland]
Well, and as you already mentioned, Mark Cuban's pharmacy has made it readily available to some. I've had some who've had some trouble with it, but most of the time these estrogens are pretty expensive on the patient's insurance plans and so if they're not using it appropriately, then they might as well just be flushing it down the toilet because they're not getting the benefit that they need. That's how I talk to patients. If you're using it one day a week, that's not enough to keep you where you need to be so don't even spend the money then.
[Dr. Rachel Rubin]
Letting them know that it's two to three months to start working. Mrs. Jones, if I gave you an acne treatment, it's not going to work tomorrow. It's going to take three months to start to see effects. The tissue has to regenerate, it has to heal, it has to plump up. Give me two to three months and then keep going. Two to three months. They really have to understand in that two to three months, their symptoms might not be immediately better. They may even get a yeast infection in which I say treat it with a Diflucan or whatever you use to treat yeast infections, but keep going with the vaginal hormones. Oh, this is a new one. Patients who say they feel itching with it. If it's not a yeast infection, has anyone ever had itching when a sunburn starts to heal? Your tissue's starting to heal and so it might be a little itchy. That's where I sometimes like the inserts as opposed to the creams because sometimes the ingredients in the creams can be itchy. The key is work with your patients to get the foundational product that really works for them and sometimes you've got to pivot a little bit, but don't give up. Don't go straight to your third-line OAB therapies. Get a foundational hormone product and then after two to three months, if they're still having symptoms, then of course go to your third-line therapies.
[Dr. Suzette Sutherland]
That's great advice. I think another practical piece is if the vaginal tissue is really not healthy. You have an older woman and it already looks to that almost reddish and angry stage, right? No wonder they're having a lot of burning and local irritation. They put the cream on and they say it stings and it burns so they stop. The analogy I give is if your hands are chapped, so dry and cracky, what are you going to do to fix it? You put on some cream. You know when you put it on and it burns, but you don't not put the cream on. You know I have to put on some more until it gets better. It's the same thing here. It might get a little uncomfortable until it gets to a stage where it's okay and then you won't have that burning anymore.
[Dr. Rachel Rubin]
I love that analogy so much and really, I started my own private practice about a year and a half ago and I didn't buy an ultrasound machine and I didn't buy a Eurodynamics machine. I bought $7.99 mirrors on Amazon, like the ones, the bigger ones with the big handles and it has revolutionized my practice so much so that the New York Times wrote a whole piece in the science section about it because we're showing women their own bodies and it's so revolutionary because women can understand GSM if you show it to them, right? It's not just a little vaginal dryness. Look how irritated this tissue is. Look, it hurts here but not here. Look at this pH. Look at how it looks like a sunburn. They won't forget their products when they can see it with their eyeballs.
(5) Debunking Myths About the Use of Vaginal Estrogen
[Dr. Suzette Sutherland]
I wanted to go back to something that you already mentioned, the boxed warning. What's wrong with the boxed warning? Why should they not believe what's in there? Then tie that into the WHI studies, the Women's Health Initiative studies that came out a number of years ago and caused a generation of women to stop all of their post-menopausal hormones and then the fallout from that, the problems we had and we're trying to make up from that. So many, even well-meaning providers are telling patients, well, you don't want to use that estrogen because it's going to cause a lot of problems with stroke, heart attacks. All these studies show that. Can you debunk that myth as well, please?
[Dr. Rachel Rubin]
This is where the AUA absolutely needs to get involved from an advocacy position and I'm going to flex and get them involved as soon as possible because we must change the box labeling on vaginal estrogen because almost nothing that the box says is true. If you look at a box of vaginal estrogen, it says it causes stroke, blood clots, heart attacks, dementia, and must be used with progestin. None of that is true. All of that is based on systemic hormone therapy. Most of it is not true, but it is no data for local vaginal hormones to need any of those things and there's no data to show that vaginal hormones causes stroke, blood clots, cancer, dementia and we know that you don't need to use a progestin with vaginal hormones. The FDA is actually killing women. I'm going to say it. They're killing women by having that box labeling on there because women are dying from urinary tract infections. Medicare is spending between $6 and $22 billion a year on urinary tract infections that they wouldn't have to spend if women were given vaginal hormones. By trying to overprotect women, we're actually killing them and we have to change that. I'm going to put it to you, Dr. Sutherland, because me, I get lots of time with patients and I go into all the data of the Women's Health Initiative and I say, wait a minute, with systemic estrogen, there was a decreased risk of getting and dying from breast cancer so how is local estrogen going to cause this? I go really into it, but you don't have all the time in the world with your patients so what is your spiel? What do you tell patients about the black box? Because I believe we have to educate patients before they leave that office. Because I don't know what it is about vaginal estrogen but women read the box. They all read the box and nothing else. Nobody reads the box of anything else except vaginal estrogen, so what do you tell them in your shorter visits?
[Dr. Suzette Sutherland]
Yes, basically the same thing you just did but I try to do it a little bit in an elevator speech-type mode. Mostly the take-home message is that the black box warning information is based on systemic estrogen and that's not what I'm advocating for you. We're talking about a small dose that goes locally. Sometimes they talk to another provider and the provider says, but it can be absorbed systemically if you put it into the vagina, and I say, yes, if I tell you to take the applicator and fill it up six times and put it in and do that every night, well, that's a huge dose.
The vagina is a very vascular space and it will definitely get absorbed but that's not what we're advocating. We're talking about a low dose, very small, low dose that stays vaginally and there are a number of studies that have looked at systemic estrogen. You know this very well. Looked at systemic estrogen after low-dose vaginal use and no change, no bumps in the estrogen levels systemically. It does take a lot of education on our parts. I liked what you said. The patients then are labeled noncompliant and the way I would say that is that the responsibility falls on us. They are undereducated, but that's my job, my job to educate them so if they don't understand it, I didn't do it well enough. I do have women who come even after that big spiel. I find out when they follow up at their three months to see how things are going and they stopped using it after two weeks because, "I don't think it was really helping. I was worried about it and I was worried about the estrogen." I said, we had this conversation, so we have the conversation again. Sometimes it takes two conversations. People are really nervous about it and so, I totally agree with you. We need to get out there and advocate against this black box warning because we are hurting patients and it's an uphill battle when other providers are telling their patients the harms, what they think the harms of the estrogen are and it's not based on contemporary data.
[Dr. Rachel Rubin]
You know what's so fascinating? I think we went wrong in a lot of ways trying to understand this. I think we went wrong with calling this a little vaginal dryness, right? A little vaginal dryness means it's okay, lady, suck it up, use a lubricant, use a moisturizer. It's no big deal. You're okay. GSM, genitourinary syndrome of menopause is not a little vaginal dryness. It's pain with sitting. It's pain with pants. It's urinary frequency and urgency. It's bladder pain. It's opioid use. It's literally not being able to be intimate with your partner who you love so very much because it feels like shards of glass. It's recurrent urinary tract infections, which can get you with a PICC line needing IV antibiotics because you have resistance, and so this idea of, oh, well, we don't know the dangers of vaginal estrogen.
There is no data showing danger to vaginal estrogen, but there is a lot of data showing how dangerous genitourinary syndrome of menopause can be. Take a medicine like Tamoxifen, okay? We use Tamoxifen. It's another CIRM for breast cancer prevention. It can cause uterine cancer. It can cause blood clots. It can cause osteoporosis and what do we say? Well, it's going to prevent your risk of getting a breast cancer recurrence, so the benefits outweigh the risk. How can we say that about Tamoxifen, but then say that vaginal hormones, the benefits don't outweigh the risk? Oh my God, the benefits outweigh the risk time and time again because no one can show me a paper that shows actual risk, right? That's the part that I can't understand is how this is so obvious. It's so easy. It's so available and has been since the 1970s, but the reason we're not pushing it and doing it, it's because we're not selling it. We don't even find it important enough. That's where the advocacy must come in.
[Dr. Suzette Sutherland]
Well, sign me up. I'm happy to help to go fight the FDA to change that black box warning. Let's go, girl.
[Dr. Rachel Rubin]
We're doing it. We're going to create an army. We're already starting the conversations and really, we're really just trying to figure out what is the path? What are the meetings? Who do we have to talk to? What are the studies that they demand? Who do we have to have at the table? Then we're going to be yelling to the AUA to come help us and ACOG and NAMS and the cancer people. Like, we got to get everyone involved because this is something that everyone either doesn't care about or agrees upon. Nobody is sitting there saying, no, no, we must keep this box there. It's protecting women. I've never heard anybody say that except the FDA.
[Dr. Suzette Sutherland]
Well, along those same lines, we do have a committee. I believe you're on that committee working with the AUA to put together some definite guidelines about GSM, not only the evaluation of but then proper treatment. We're hoping to see these guidelines that have a lot of practical information that people can use. Can you tell me a little bit about the process of putting these guidelines together? What does it take to do this? What are you guys doing to prepare for this and when can we expect them?
[Dr. Rachel Rubin]
Yes, this was a dream come true. Many of us have been yelling and screaming on Twitter for quite a number of years now saying, we've got a guideline for premature ejaculation. We've got a guideline for OAB. The UTI guidelines did a nice job of saying we should be prescribing vaginal estrogen to prevent urinary tract infections, but they didn't go far enough and so by asking the AUA to do a guideline that's specifically focused on GSM, it does so many things. Number one is it tells urologists, this is our lane. This is our medical problem. This is a urologic issue that has urologic solutions and as board-certified urologists, we are supposed to be taking care of men and women, and we have tools to take care of women. It's just that oftentimes nobody taught us how to use them and so this guideline can be tested on. There could be board questions on it.
It will hopefully force insurers to actually realize that this isn't just a little vaginal dryness, but these products must be covered by Medicare, must be covered by commercial insurances. The guideline is a very thorough process. There's a big group of us and a large data review of all of the data that exists and then we'll be meeting over the next couple of years. It's quite a long process, actually, to go and to give our guideline statements. I'm hopeful that in the next year or two, they will start to emerge, but my goodness, it is an absolute dream come true.
(6) Vaginal Estrogen in Patients on Systemic Hormone Therapy
[Dr. Suzette Sutherland]
Yes. Well, I'm so happy to. We'll have some official information from the AUA. I'd like to take this opportunity to get into a couple of more controversial areas that are specific to the use of vaginal estrogen. You mentioned a little bit here, but one of them is women who are already on hormonal replacement therapy, HRT. When we say that, we usually mean systemic estrogens and or progesterones, right? For those systemic symptoms of hot flashes, night sweats, mood swings, things like that. Some of these women we find still need a little bit in the vagina to keep the vaginal tissue healthy. What's your experience and your recommendations about that?
[Dr. Rachel Rubin]
Totally. I think more people need it than don't need it. If you have a lady who comes to see you who is on her patch and it's helping with her hot flashes or night sweats, but she's still having urinary frequency, she 100% should be on a vaginal hormone product. I find that very rarely actually is a systemic therapy enough to cover the GSM symptoms. What I think that we're doing poorly is screening for GSM symptoms and if the woman says, well, I don't have vaginal dryness, but she has urinary frequency or she gets a UTI, I think we need to understand that that's GSM. Just because you don't have all the symptoms doesn't mean that the hormones aren't playing a role and so I would be very quick to give localized therapy. Now there is a product and a few products that are being studied right now that sort of do both and there are vaginal rings that provide both local and they're high enough dose that they provide systemic estrogen therapy. Now if a person has a uterus, if you're doing high-dose systemic hormone therapy, they must be on a progesterone to protect the uterus from proliferation and potential uterine cancer and so using low-dose vaginal hormone products, you don't need to use a progesterone, but high dose hormone therapy for menopause symptoms, you do need a progesterone. There's a ring called a FemRing, which is a high dose that we use quite often and it does both hot flashes and vaginal symptoms and GSM symptoms. There is a company that is studying a ring right now, they just published last week on their initial data on a ring that has estrogen and progesterone in it so that's quite exciting, actually.
[Dr. Suzette Sutherland]
Wonderful. These rings too, oftentimes I get the question, do I need to take it out if I'm sexually active? The answer is no.
[Dr. Rachel Rubin]
Yes, I say most penises don't notice it, to be honest. Like baby's heads can fit through a vagina, so there's stretchy room in there for everybody, but what I say is if it bothers your partner, you take it out, you put it back in. But I would say like 90 percent of my patients leave it in for sex and they're not bothered by it.
[Dr. Suzette Sutherland]
Yes. Another controversial area, of course, is in the area of cancer so we always think about breast cancer, we see a lot of those patients, but also endometrial cancer or cervical cancer and survivors. What kind of advice are you able to give there from the contemporary data that we have today?
(7) Vaginal Estrogen in Patients with a History of Cancer
[Dr. Rachel Rubin]
This is why I love spending time getting to know my patients, customizing their care to their specific problem. Again, there is data that shows there's no risk of vaginal hormones in endometrial cancer survivors, in cervical cancers, or ovarian cancer survivors. There's actually data on the breast cancer side that shows no risk of recurrence with Tamoxifen use, whereas there is still some pause in the Anastrozole patients. The purpose of Anastrozole is to block every type of estrogen ever to make there be no estrogen in the body. A lot of oncologists were concerned about using local vaginal hormones with the purpose being that we don't want any estrogen in the body. There's one recent paper that shows a mild blip of a concern with those women on Anastrozole and using vaginal estrogen but that data hasn't been replicated, and even that data was wrought with many problems and older data, even, honestly, before HER2Neu status and some of the new breast cancer therapies so it wasn't really a good study. We don't have any good studies to show real harm with vaginal hormones and breast cancer and we have a lot of studies that show no issues and no harm.
What I tell patients is, again, what are the benefits? What are we trying to treat here? Alcohol is a perfect example. A lot of breast cancer patients will still drink alcohol every now and then, and that's a much higher measurable risk of harm and carcinogen. You have to understand, is this inhibiting you from being intimate with your partner? Do you have frequency and urgency and you're getting up all night because you're leaking and you have to urinate? Do you have an overactive bladder? Can you not sit or wear jeans? Again, with a cancer patient, it's, we treated you so we could keep you alive, but how are you living? Can we make you live better? Do we have all the information in the world? No, but we make the best decisions that we can with the information that we have in 2023. The problem is a lot of your doctors are not updated to 2023. Their brains are back in 2001 and so you have to find the right medical community to give you good advice and to have what we call shared decision-making. Dr. Sutherland and I, we treat men all the time and we do shared decision-making, right? Where it's your body, your choice, and we have to really understand what those decisions are.
[Dr. Suzette Sutherland]
Yes, so how about the patient who, you mentioned it a bit in maybe somebody who's actively being treated, but just on Tamoxifen, the estrogen blocker, and maybe not such a situation where they're trying to block every little thing because they are high risk with all the receptors and all that. We see a lot of patients on Tamoxifen and they're maybe four and five years out towards the end of their Tamoxifen use. The use of some local estrogen in those situations, many of them say, well, the providers will say, well, it won't work because you're going to block that local estrogen. Can you speak to that?
[Dr. Rachel Rubin]
I think we need more data of will it work or not work, but we certainly don't have any data that shows major harm, especially in the Tamoxifen patients. That actually is a place where DHEA may come to the rescue and where certainly the menopause society and the cancer societies have said, DHEA is quite interesting here and we need more studies, but we even have a study with DHEA that shows that even patients on Anastrozole who took DHEA had persistent decrease in recurrence of urinary tract infections so it still worked. It worked quite well and so we need more data. If we cared about women, we would do the data, right? Oncologists should want to answer these questions because they're the ones, patients are going off their Tamoxifen, they're going off their anastrozole because they're having wildly unpleasant sexual side effects and one of those big side effects is genital urinary syndrome of menopause.
(8) Genitourinary Issues in Premenopausal Patients
[Dr. Suzette Sutherland]
Yes, and we certainly don't want them to go off of their cancer therapy, but we want to be able to sort of support them through the symptoms that they develop along the way, most definitely.
In another area, of course, we see every once in a while, not as often, but still, I feel like I see it more these days, they're coming out of the woodwork, but premenopausal, right? Not only perimenopausal, I think perimenopausal still can fit into the same postmenopausal as far as the symptoms that they're having and what to do about them, but we have premenopausal, young women in their 30s and they're having these kinds of symptoms or other vestibulitis kinds of symptoms and the use of estrogen. Often it's, well, if you're menstruating, you shouldn't need any, right?
[Dr. Rachel Rubin]
This is a delicious question and thank you for asking it because I think this is where we need even more loud voices and more research and more data. I think, again, genitourinary syndrome of menopause is a lot better than vaginal atrophy, but it also has limitations. I think it instead should be genitourinary syndrome of hormone-depleted states or something like that because there are more people who have hormone problems than just menopausal women and so let's start with the most obvious is women on birth control pills.
This is a huge elephant in the room that we are not talking about. When you take a birth control pill, you have the ovaries shut down and you say, don't ovulate. Then you replace estrogen, fake estrogen, and progestin, and you don't replace testosterone, so now you have a very important hormone, and women have more testosterone and more androgens in their body than they have estrogen. Now you have millions and millions and millions and millions and millions of women who are not getting any testosterone into their symptoms. The data seems to show increased anxiety, decreased libido, and increase in sexual pain. The microbiome goes to hell because, remember, we said there's testosterone receptors in the bladder and the urethra and the vagina. I think a lot of this recurrent UTI, interstitial cystitis, vestibulodynia, symptomatology that we're seeing is often due to the changes of hormones with birth control pills and so in my practice, we get women off oral contraceptives. We love IUDs because they don't stop ovulation, either hormonal or non-hormonal and then we add back. Vaginal DHEA is a perfect product in this situation because it adds back an androgen. We add back vaginal estrogen. We add back a compounded estrogen-testosterone because there's no FDA-approved product to rub on that vulvar vestibule. We have to understand the hormone changes our patients are going through. We have lots of patients with disordered eating where they don't have normal hormones in their body because they're exercising all the time or not getting the nutrition that they need. We have patients who are breastfeeding who are in menopause. We have transgender patients who are just using testosterone, so they're not getting enough estrogen. There are numerous patients that have hormone changes and they're not in menopause. My answer back to you is there is no harm by adding back. There is no harm by putting more local therapy. There is no worst-case scenario because you can't hurt a patient with this stuff. That's my two cents. What do you think? How do you think about this?
[Dr. Suzette Sutherland]
Yes, I think very similarly in the pre-menopausal woman. Also, if there is a local issue, right, and you're trying to heal that local tissue and help them feel better, get rid of those irritative symptoms. The way I talk to them, they're oftentimes nervous about, is it going to do something, cause more proliferation on my endometrial lining, right? I'm like, well, but you get your period every month if you are still menstruating, right? So you're going to shed that. The proliferation, the risk of endometrial cancer happens with unchecked proliferation.
Keep going on and on and on, right? That's how I try to ease their mind and get rid of the anxiety. The truth is that any of these women, pre-menopausal, post-menopausal, breast cancer survivors, whatever it is, if there's anxiety about the use of estrogen in their mind, they are not going to use it and so that's why it's so important, as Rachel already said, for us to get rid of this black box warning. We need to educate the patients, of course, but we also need to get out there and educate other providers so their patients aren't getting the wrong information and augmenting all of their anxiety. Of course, breast cancer survivors, we understand why they're anxious, right? We need to be able to combat their anxiety with really good data.
[Dr. Rachel Rubin]
One thing I use in my practice is numbers. I think numbers are helpful to patients. You say, okay, if you draw my blood right now, my estrogen is probably between 50 at its low and 150 when I ovulate, right? Depending on where I am in my cycle. When I was pregnant, my estrogen was probably 3,000. My husband's estrogen is 25, right? My mother's estrogen is zero or less than five. That's as low as the lab value goes. When we give vaginal estrogen, my estrogen will stay between 50 and 150. A pregnant woman's estrogen would stay 3,000 and my husband's estrogen would stay 25 and my mother's estrogen would stay 0, right? That's the magic of numbers because patients understand the numbers don't budge. So how, if the numbers don't budge, are you gonna get stroke, heart attack, blood clot, dementia, proliferation, all of these things like it just, there is no data. This is fear. This is just illogical fear that you have to combat with actual numbers to people, which I think is quite helpful for people to understand.
[Dr. Suzette Sutherland]
Great. Well, thank you. This was really wonderful. I don't know if there's anything else that was on your mind you want to share with this audience about this topic that I didn't ask you.
[Dr. Rachel Rubin]
I just want urologists to give a crap about this. I want urologists to understand that this is urology. This is urology 101. If I can help give you the tools to use this in your clinic, have people follow me on social media because it's what I talk about all the time. Have them go to our YouTube channel, have them go to my Twitter, a pinned thread, use us in the field, right? There's a lot of people on social media who are doing this loudly to help you, to help back you up when your patients get nervous, to help know that the data supports you, that if you don't want your mesh to erode, have them use vaginal estrogen for a lifetime. You don't want that lawsuit because of the vaginal mesh eroded. Yes, third-line therapies are great, but they'll actually work better if they're on the foundational vaginal hormones. All those penile implants you're putting in, where are they going to go if their partner has genitourinary syndrome of menopause? You can't just say, well, I'm a men's health specialist. I don't take care of women. You take care of women every day if you take care of their partners and so you have to care about this. You yourself have a mother and a grandmother and aunts, and people are getting urinary tract infections, and you know they're calling you every time they do. Those phone calls will go down if you just recommend this therapy and recommend it correctly and sell it correctly. Thank you if you've listened this far. I'm so grateful.
[Dr. Suzette Sutherland]
Yes, well, thank you very much. The big take-home message is that GSM, genital urinary syndrome of menopause, it is an issue. It's not something to be poo-pooed. We need to look for it and talk about it with patients. The more you talk to patients, you'll find how ubiquitous this really is among your patients, and then the safety of using local vaginal supplementation in the form of estrogen. I think we beat the dead horse here by talking about how safe it is, and you've supplied some lovely data supporting that so we really should be using some of this vaginal estrogen in order to help these women and get the black box warning off. We're looking very much forward to our academic societies, the AUA, SUFU, OGS, getting involved and putting together some robust guidelines to really help the practitioner out there so they can be doing this work as well, so thank you very much, Dr. Rubin. It's been an absolute pleasure to have you. Thank you.
[Dr. Rachel Rubin]
Thanks for having me.
Podcast Contributors
Dr. Rachel Rubin
Dr. Rachel Rubin is a urologist and sexual medicine specialist in North Bethesda, Maryland.
Dr. Suzette Sutherland
Dr. Suzette Sutherland is the director of female urology with UW Medicine in Seattle, Washington.
Cite This Podcast
BackTable, LLC (Producer). (2023, September 18). Ep. 33 – Genitourinary Syndrome of Menopause (GSM): Improving a DRY Topic [Audio podcast]. Retrieved from https://www.backtable.com
Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.
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