
A Practical Toolbox for GSM: New Guidance From the AUA
Rachel S. Rubin, MD: Welcome back to another episode of Sex Matters . I'm Dr Rachel Rubin. I'm a urologist and sexual medicine specialist, and I am honored and beyond thrilled to introduce you to my next two guests who were the co-chairs of the new guidelines for the genitourinary syndrome of menopause (GSM). Now, if you are a primary care clinician — really, if you are any clinician who takes care of women — you must know about these new, exciting, wonderful, multidisciplinary guidelines all about GSM. Dr Melissa Kaufman, why don't you begin with a short introduction?
Melissa Kaufman, MD, PhD: I'm Melissa Kaufman. I'm really delighted to be here and spread this word to all my colleagues. I am a urologist and I work at Vanderbilt University in Nashville, Tennessee.
Rubin: And Dr Una Lee?
Una J. Lee, MD: I'm Una Lee. I'm a urologist and a female urology specialist at Virginia Mason Franciscan Health in Seattle, Washington.
Rubin: All three of us were a part of this very multidisciplinary guideline that was endorsed not just by the American Urological Association (AUA); Dr Kaufman, who else endorsed this really important guideline that everyone needs to know about?
Kaufman: It's pretty amazing. The American Urogynecologic Society; the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction; and the Sexual Medicine Society of North America also endorsed this guideline. It was created by the Patient-Centered Outcomes Research Institute, in collaboration with the Agency for Healthcare Research and Quality. Many stakeholders were engaged in order to create this guideline, including patient stakeholders.
I'm so appreciative, Rachel, that you've had us here today. Millions of patients are going to benefit from this landmark endeavor, and getting this message out to all providers who treat women is critically important. So, accolades to everyone who's been involved.
Rubin: What's so fabulous about this guideline is that it stemmed from the need of so many women who suffer with both the genital and urinary consequences that occur when they experience hormonal changes. So, Dr Lee, what is GSM? Why does it need a whole guideline?
Lee: Great questions. Great introduction. I want to loop back, Dr Rubin, because you and I talked about this years ago. This has been years in the making. I think it was 2021 or 2022 when we proposed this to the AUA. It takes years for this kind of effort to be coordinated, for the evidence to be collated together, and to bring all these stakeholders together. So, thank you for being the spark and part of the inspiration.
But full circle, GSM is a clinical syndrome and diagnosis where the levels of estrogen in the tissues decrease and it creates symptoms of discomfort, burning, urgency, frequency, vulnerability to UTIs, and pain with intercourse. It does not feel good. It feels like you have a UTI but you may not necessarily have a UTI. It feels like you have an overactive bladder, but you may or may not actually have one. There are signs and symptoms that you can see on exam, but it is a very encompassing, impactful, and treatable condition that affects a lot of women across the lifespan — particularly in menopause and beyond, but there are other women who suffer.
Rubin: One of the amazing things Dr Lee didn't tell you is she published a paper that looked at about 1500 women, and nearly all participants had at least one symptom of GSM; you can have a urinary symptom, you can have a vaginal symptom, or you can have dryness. What is so landmark about these guidelines is that these symptoms don't just occur during menopause, right? That word "menopause" in the term "GSM" is a little confusing because these symptoms can happen in many different types of patient populations. It occurs in perimenopause. Dr Kaufman, what other conditions does GSM occur in?
Kaufman: So many women and so many patients suffer from these symptoms, and it occurs across a very broad spectrum. We're talking about women who are taking oral contraceptives and women who are breastfeeding. They may have some of these symptoms but they're not in that traditional perimenopausal period. So, everyone needs to be screened when they're coming in with these signs and symptoms that, as Dr Lee mentioned, may really be detractors because they can be very complex in terms of the physical changes that go along with them.
I think this guideline helps provide some very pragmatic statements to allow very rapid implementation, and it truly promises to be transformational. One of the things that we see in many patients who are in menopause and perimenopause is that these vasomotor symptoms that we typically assign to menopause (because of the changes in the estrogens and the androgens during this time period) will abate over time, but these genitourinary symptoms associated with GSM actually increase pretty dramatically over time. So, it's necessary — even if other systemic symptoms abate — that we look for these treatment solutions.
Rubin: It's important to emphasize that this is not just a urology problem, right? This is a problem for your primary care clinician, for your gynecology clinicians, and even your orthopedic surgeons need to know about this. Why? Because if you're getting a hip replacement and you've got symptoms of urgency and frequency, you might get readmitted for a UTI. Or how about the hospital team that are always looking at catheter-associated urinary tract infections (CAUTIs) and all of these ICU-based urosepsis admissions?
These are preventive tools that our patients can use to prevent UTIs and have really improved quality of life. That's what I love so much about these guidelines: They are an easy-to-read handful of statements — that can be implemented quickly — that describe the currently available treatments and why they're safe to use.
So, let's get into it. Not only should we ask our patients if they have genital and urinary symptoms, but we also should ask about and encourage a multidisciplinary approach — which is, again, quite landmark. Tell us more about what the guidelines say about including our other colleagues in this space.
Kaufman: We want to do what we would call "shared decision-making" across the spectrum for these patients. Some of that may include engaging primary care providers to help make these decisions, but what it really means is that it's a very patient-centered approach. It's a dynamic, collaborative process. It's a process that takes someone's value system into account, and sometimes that value system may include consideration of treatments for other conditions, such as other cancer treatments. We see many, many women who have undergone cancer treatments for breast cancer, for gynecologic cancers, and other systemic issues that may need us to use multidisciplinary decision-making in order to arrive at the best consensus opinion as to what path of therapy is going to be ideal for that individual patient. It is very preference-sensitive. When we talk about shared decision-making, this is a real living entity. It's not just words on paper that people utilize to say that they're trying to do something in the patient's best interest. We've explicitly put it in these guidelines to make it operational for the provider to help with patient care.
Rubin: One of the things I love so much about this guideline is it truly is a toolbox that you can give to patients and use to offer treatments. The guideline no longer takes the approach of "this is the first-line therapy and you have to fail the first-line therapy to go to another option." It is a toolbox. If you need a pelvic floor physical therapist, you should find one. If you need a mental health professional, you should find one. You should use vaginal hormones because those are shown to prevent UTIs and can help with overactive bladder symptoms, dyspareunia, dryness, and quality-of-life issues. Of course, moisturizers and lubricants are great tools in your toolbox to help with symptom management, but they don't necessarily address the urinary symptoms.
Dr Lee, why don't you talk to us about what the toolbox looks like when it comes to hormonal approaches to treating GSM?
Lee: We have very compelling and accumulating data on the efficacy and safety of low-dose local vaginal estrogen for the treatment of GSM. I think that it comes with a conversation because people have a lot of misconceptions.
First of all, local, low-dose vaginal estrogen is different from menopause replacement therapy — systemic therapy — which is for vasomotor symptoms, like hot flashes. You can actually be on both vaginal estrogen and systemic therapy safely, if needed and if appropriate, or you can be on one or the other. That would be the mainstay of treatment — vaginal estrogen in the form of creams, suppositories, or a local ring called Estring. They're equally efficacious. It's a patient preference and an insurance coverage issue. I like to prescribe what is covered by their insurance as a starting point so that they initiate therapy as quickly as possible. Get the benefits at a reasonable cost.
In the paper Dr Rubin quoted, this national sample of women reported their experience with and barriers associated with vaginal estrogen therapy. Two of the major barriers were financial barriers, because treatment can be costly, and concerns about medication side effects. So, I think we have to address those upfront and tell patients about the benefits so that they understand that the benefit is worth the out-of-pocket cost and that this treatment is safe. It does not cause cancer. It does not cause death. It actually helps quality of life, symptom control, and prevention. Once our patients understand this, they're much more likely to be adherent and receive those benefits.
Rubin: Absolutely, and again, what I love is that it's all about education, which is really what we're great at. The guideline teaches you that there are no data to show that local low-dose vaginal estrogen causes breast cancer. There is no fear or risk of endometrial cancer with these very low-dose products. We must have these shared discussions, even with our patients with breast cancer, because the quality-of-life issues of GSM are so drastic that, for many of our patients, the benefits of therapy far outweigh the risks.
This is where we give that toolbox. There are tables within the guidelines that outline doses and how to prescribe these products. In addition to vaginal estrogen, there are strong data on vaginal DHEA and a SERM — ospemifene — that can be used as well and has been shown to help with GSM symptoms.
Now, a lot of people get all these ads on TV for lasers, right? They're being told to get vaginal rejuvenation laser therapy. Dr Kaufman, what was the guideline consensus on these fancy and expensive lasers? Are we there yet?
Kaufman: Well, we're not quite there yet, although there are some data that would be supportive. There are certainly some randomized trials that would suggest it's useful. But when we looked at the data in their entirety, there really wasn't evidence to support the use of any lasers in the treatment of the GSM-related vaginal symptoms, like dryness, discomfort, dysuria, quality of life, or dyspareunia.
Although you may consider these for certain patient populations that absolutely are not candidates for vaginal estrogen or prefer this as an alternative, the data are not compelling, and these were relatively high-level data that we use to make those opinions.
Rubin: How do you follow up these patients with GSM? Are these treatments something they use for a weekend? Is it short-term? How do we talk to these patients about these therapies, Dr Lee?
Lee: I smile because that is a common thing that happens. Patients come back and they say, "Well, I used the prescription and then it ran out, so I stopped." We need to counsel them on the ongoing use for the continued benefit. It sometimes takes a few weeks to a few months to get the full benefit, so we should set that expectation. Patients need to use it continuously. We do a lot of things for maintenance. I think about all the face creams I use on my face, and I'm okay with using that for the rest of my life. I'm also okay with counseling my patients on the use of vaginal estrogen to maintain vaginal health, bladder health, urinary health, and prevention of UTIs in patients with that treatment indication. I think we need to counsel them on the continued use, the risk benefit — high on the benefit, low on the risk — and the need for follow-up. They need follow-up because it's a prescription that could be refilled by all the amazing PCPs out there who see their patients for maintenance and medication refills.
Rubin: I absolutely love that, and I think the guideline's very clear about how we would love for you to do exams. And we do go into full detail on how to do exams: how to look at the labia, how to look at the urethra, how to look at the pelvic floor — we go into full detail. But this is something you can prescribe through telemedicine after speaking with your patients. You will not cause harm. Using these vaginal hormone therapies will ultimately help the microbiome and acidify the vagina to make good, healthy, lactobacilli grow so that you fight infection, prevent UTI, and make sex not painful. It can help with lubrication and orgasm. I always joke, "Vaginal hormones are better than Viagra because they're like Viagra but they prevent UTIs."
These products are usually inexpensive. There should be a product covered by insurance, but if not, some of these cash price options of coupon cards or online pharmacies offer a tube of estrogen cream for about $13. Get comfortable with the costs, because those should not be barriers anymore.
Dr Kaufman, what would you say to a clinician who says, "Oh my gosh, my patient had bleeding after I gave her vaginal hormones. Did I cause harm? I'm a primary care doctor; what should I do?"
Kaufman: Those are very common issues that may arise in some instances, and the guidelines certainly encourage clinicians to send their patient to an appropriate provider that can help if there are any questions. That is part of the collaborative nature.
Some of it may be trauma from the way that the estrogen was applied, so there may be issues with application. Sometimes if patients experience bleeding, they do need to undergo an evaluation by a gynecologist or someone who can help, depending on their other status. It would be quite rare that some of these things may happen, but this is another aspect of that multidisciplinary care you spoke about earlier.
Rubin: The guidelines are very clear that you don't need to routinely do endometrial surveillance, so if a patient is not bleeding, you don't need to follow it. If any postmenopausal patient does bleed, they should get a workup by a gynecologist, right? That's normal care that we're all used to anyway.
Dr Kaufman and Dr Lee — as co-chairs of this project, this was your baby. You wrote this incredible, collaborative, beautiful document. What are the major takeaways you want people to know? Because it's not just about writing this document; it's also about getting it into the hands of all of the clinicians and all of the patients who truly need to see this beautiful work that you've all done.
Kaufman: It's this increased knowledge and the awareness that it's going to manifestly transform women's health. This has remained a glaring deficiency for all the time we've been practicing medicine, and likely for thousands of years before this. These types of issues have been pushed off to the side. Conditions that are very easily treated have been marginalized.
So, I really want to get across that these guidelines are operational. The solutions for GSM are simple, effective, safe, and generally very inexpensive. They are very easy for clinicians to implement. You are going to take care of several comorbid conditions like UTIs, overactive bladder — you may even take care of conditions that we don't recognize today, such as changing a patient's entire microbiome, which may in turn change their bowel symptoms. We don't know all the implications, but we do know that these guidelines are going to transform the way that you interact with your patients. These guidelines will not only improve quality of life, but they will also improve patients' overall medical morbidity and mortality.
Rubin: I couldn't agree more. Dr Lee, as the co-chair for this incredible collaborative document, what do you really want people to take away?
Lee: These guidelines are evidence-based, patient-centered, and are going to give clinicians around the world the confidence to put this into practice. One of the most rewarding things I do in my daily clinical practice is meeting women, diagnosing them with GSM, treating them, and then seeing how their quality of life and symptoms dramatically improve. When you incorporate the tools in this guideline, you'll be that partner for patients in this journey and help them along the way.
The awareness of GSM is growing exponentially. It's in the media. It's in the news. Women are so grateful for this knowledge to be out there. Like Dr Kaufman said, I think this is going to be transformative and impactful, and this is just the beginning.
Rubin: It's been so incredible to witness this whole process get carried out, and I'm so grateful to the AUA for investing in these guidelines — for caring about women's health in this very big way. It is so transformational and important.
Spreading awareness about this guideline is going to spark even more research and even more knowledge, which we so desperately need in women's health. I'm so grateful to these incredible mentors of mine for joining me today. We hope you all read the AUA/SUFU/AUGS Guideline on Genitourinary Syndrome of Menopause and let us know what you think.
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