July 27, 2011

This is adapted from an interview with Dr. Howard Glazer, who has developed a treatment for this condition using a form of biofeedback. This initial interview, covers the history of the disease, as well as Dr. Glazer's background.

This is adapted from an interview with Dr. Howard Glazer, who has developed a treatment for this condition using a form of biofeedback. This initial interview, covers the history of the disease, as well as Dr. Glazer's background. The subsequent sections will cover treatment, results, and follow-up information.

Dr. Mark Smith: "Dr. Glazer, why don't you give us a general history of vulvodynia, then kind of lead into how you got involved in it."

Dr. Howard Glazer: "The diagnosis of dyspareunia does not, in fact, appear in historical medical literature, which is very interesting. If you look at the pain literature and the definitions of all of the sources of pain, dyspareunia is absent and appears only in psychiatric literature. Therein lies the history of the ignorance of the disease because if doctors cannot identify growths - anatomical or physiological pathology, infectious diseases, dermatoses, neurological, or whatever - then these disorders are labeled as functional. 

When you're dealing with women's genitals and women who do not by appearance or diagnosis have anything wrong with them, of course, the conclusions are often psychological in origin, and I think the literature has shown that. One of the interesting quotes was from the 1950's essentially suggested that these women are all 'frigid.' Now, we're talking about pretty recent history - 40 or 50 years ago, not thousands of years ago. So I think the gynecology literature has basically ignored these conditions as psychologic in etiology. Of course, we now know that they are very much not, although there are psychological mediating factors that we can talk about.

It wasn't until the formation of the International Society for the Study of Vulvovaginal Diseases (ISSVD) - formed not that long ago, I guess, in the 1970s, by a specialty group of dermatologists, gynecologists, and pathologists who study vulvas - that people began taking this condition seriously and the medical community started studying it. So only in the past 20 to 25 years has it been seriously looked at from the dermatological, infectious diseases, pain kind of perspective. In the past ten years, we've been looking at the role played by pelvic floor muscle dysfunction and broadened out our perspective with respect to medications.

Dr. Mark Smith: "Interesting."

Dr. Howard Glazer: "Given the overlap in incidence of occurrence between these conditions and other inflammatory disorders, including irritable bowel syndrome, interstitial cystitis, fibromyalgia, and other mucous membrane inflammation disorders, I think this is a spectacularly important finding which should lead to something. It looks like inflammation is a tremendously important central element in these conditions. That kind of brings you up to date on the conditions, in a broad picture."

Dr. Mark Smith: "Could you tell us how you got involved in this?"

Dr. Howard Glazer: "Sure. I have a Ph.D. in neurophysiology and a Ph.D. in clinical psychology. My original doctoral work was done in neurophysiology and neurochemistry, and then I moved into behavioral medicine with an emphasis on sex therapy, so it kind of all comes together with respect to pelvic floor muscle dysfunction. About twenty years ago I started doing surface electromyography of the pelvic floor, mostly related to gastroenterological disorders and to urologic disorders of incontinence and retention, some interstitial cystitis, functional constipation, and things like that. This leads to some very interesting stuff, relating to how a psychologist comes into this field to begin with, which may seem strange. 

Pelvic floor muscle surface electromyography is a form of biofeedback. Biofeedback has its origins in learning theory and neurophysiology of learning theory. It was first used in the laboratory to try to determine whether or not different branches of the nervous system were subject to different kinds of learning, namely Pavlovian versus instrumental learning. This technology was seen as a way of studying whether animals could be trained to directly control visceral responses such as blood vessels and things like that, then to see whether they could also do so as a result of the administration of rewards and punishments. So learning how to increase or decrease blood flow, gut activity, or bladder activity so the muscles can be controlled as much as striate muscles can/would presumably prove that there was only one kind of learning process. It was what we call instrumental learning, and not Pavlovian conditioning, so that was the birth of biofeedback.

I have been in the field of biofeedback and electromyography since the late sixties and early seventies, and I started out with pelvic floor muscle dysfunctions and sphincteric related stuff. In 1980, I had started looking at the treatment of vulvovaginal pain conditions. Then the Columbia College of Physician and Surgeons asked if I would have a look at some women with respect to their pelvic floor muscles, since they had noticed on intravaginal palpation that they all seemed to have tight levators and that this might be related to it. They had asked around to see who in the area specialized in pelvic floor muscle dysfunction and were in turn referred to me, and that's kind of how I got into the field."

Dr. Mark Smith: "It's interesting to me that this has turned out to be kind of an off-specialty phenomena, with dermatologists and gynecologists both seeing many of the patients. Can you give us a brief scenario of the usual patient? What they go through, how they arrive at this, and when it's time to do the other things?" 

Dr. Howard Glazer: "Sure. One of the key statistics is that about 85% of these women trace the origins of their discomfort back to what was either presumed to be a vaginal infection or, most frequently, a yeast infection. They may self-diagnose it, they may be diagnosed without examination by a physician, or they may be diagnosed with microscopic examination. It's kind of all over the place, but basically, they start to itch and they either run out and buy Monistat over the counter, or call a doctor. The doctor often doesn't see them but tells them to use it, or actually sees them and tells them to use it going mostly from symptoms, even though microscopic examinations are often negative. However, on a symptomatic basis, 85% of these patients are told or believe that they have yeast infections. They start to use topical antifungals, irritate their vulvas, and just never quite seem to get better again.

That's the most common scenario. The other 15% is comprised by a small portion of people who really can't tie it to anything, who say it appeared to be spontaneous, but most of the remaining group can tie it to something, varying from irritation all the way up to trauma. That may include accidents, prolonged rough sexual activity with inadequate lubrication, surgery, and things like that. Something irritates their vulva and it just never gets better, even though whatever had been identified as the initiating irritant is now no longer present. Everything is clean in these women, but what you'll see is some pervasive or limited erythematous patching, and even this is highly variable. You might see some inflammation, point tenderness, or general spontaneous burning, as well.

Basically, there are two categories of these conditions. There is the spontaneous pervasive burning type, which we call 'dysesthetic vulvodynia,' and there is the type that occurs only on provocation. It tends to be limited to very specific areas of point tenderness on palpation. That's what has been call 'vulvar vestibulitis syndrome,' or what we have most recently been calling 'vestibulodynia.'

There is also a subset of the population who have a primary form of the condition in the vestibulitis area. This means they will tell you from the first time they ever tried to put in a tampon or have intercourse that they have had this pain, and it's always been there. So there is that population, and then there is the secondary or acquired population of vestibulodynia or vestibulitis, and then all of the vulvodynia patients have more acute onsets, typically later in life. Again, there's also a subset of the vulvodynia that seems to be hormone-related. We see a lot of perimenopausal women who start to thin out of the vulva and get a lot of these irritations.

So the first thing to understand is that even though we try to diagnostically classify these things, I'm not at all sure that these are unitary disorders. Typically, these women have seen many, many doctors. Once again, they have been symptomatically treated for infections although they were often told 'we can't identify it,' so they'll treat them other things and they'll treat them orally, vaginally, intravaginally, or topically. Again, they will often presume HPV infections or herpetic viruses, and they'll treat them with powerful drugs like Famvir and things like that if they say they ever had any possibility of having had an outbreak. Doctors can often reach for what appears to be symptomatically accurate when they can't find any positive findings on evaluation.

I'm a tertiary guy, and most of these people have already gone through a series of regular gynecologists, then through a series of vulvar specialists, before they ever get to me. So the average patient I see has had this condition for about five or six years, and has probably seen at least ten or fifteen doctors. They have been treated anywhere from respectfully but not knowing what they have all the way up to a tendency for doctors to become very, very aggressive and inappropriate and tell these women that they're screwed up in the head or that they must be gay. In their own frustration in not being able to diagnose and treat these conditions, doctors can become hostile towards these patients, and so it makes it difficult because the patients feel that they're being inadequately treated. They don't fit into a model that doctors know how to treat.

Thus, chronic pain conditions can be frustrating for doctors who have been trained on the traditional model of chronic pelvic pain. They're trained to address physiologically or anatomically identifiable acute disorders that they can treat. That's how they're educated, so it's a source of tremendous frustration for doctors who are traditional physicians to have to act in a chronic pain mode with much more time and support and all kinds of things for patients. Basically, it just isn't the way they operate. So this is to the detriment of both the physicians and the patients. It's unfortunate because this condition, although it's a chronic pain condition that exists in the genitals, has been mostly dealt with by gynecologists instead of being dealt with by chronic pain people. So that's the typical history.

There is a growing awareness of these conditions, and I now see more and more women who have had some of the basic standard treatments, even by non-specialists. In the old days, perhaps ten years ago, unless they were specialists, none of the gynecologists I talked to had ever heard of this condition. Today, although I don't know if it's taught in medical school yet, it's something that's becoming much better recognized in the gynecology community as an entity that can effectively be diagnosed and treated. So I'm seeing people now who tend to get some level of standard treatment earlier on in the game, but most of them are not responsive to this stuff.

The other thing is that many of these women have surgery. In the old days, many of them would do laser surgery with the assumption that it's HPV. This is all totally contraindicated now in vulvodynia, but there is certainly a history of surgical intervention here. In fact, skinning vestibulectomy with perineoplasty and vaginal advancement is still a gold standard for women with vulvar vestibulitis. Reports in the literature claim about 70% efficacy, but I find some fault in these reports because they tend not to follow up very well, and a high proportion of these people have recurrences that are not reported. The surgery does produce very satisfactory outcomes, but they don't do any follow-ups, and when you do the follow-up six months and a year later, you find a pretty significant degree of reoccurrence.

So that's basically the history of the women I see. All of them have failed to respond to pharmacological agents, many of them have already had surgery, and they have certainly tried all of the topical treatments. They're clear of any dermatoses, they don't have any lichen, they don't have any HSV or HPV, and they don't have any active bacterial vaginosis or anything like that. They're all clean by the time I get to them, and they're still having either chronic unprovoked variable burning or point tenderness symptoms more related to vestibulitis."

Dr. Mark Smith: "Doing only gynecology, I was actually a referral source for a lot of these women, and we've seen the whole gamut of recommended therapies." 

Barbara Nesbitt: "Howard, how did you get into biofeedback?"

Dr. Howard Glazer: "I was working in neurochemistry when Neal Miller was doing the initial laboratory research that I made reference to earlier, involving direct control of visceral functions in animals. I happened to be in the lab at the time this research - which later became clinical biofeedback - was going on. It's kind of a political story, actually. I came out of that lab in the early 1970s, and NIH funding dried up about that time. I'm not quite sure why, but the money dried up and so those of us who had been trained as classical laboratory researchers were suddenly trying to find a way to make a living. That's why I recreated myself as a clinician, and having recreated myself as a clinician and coming out of the laboratory of Neal Miller, about the only thing I could do competently was biofeedback. Even though I have a license as a clinical psychologist and have done some psychotherapy in the past, in the old days one could reinvent one's specialty much easier than today. So I changed from a laboratory researcher into a clinician, and having come out of the laboratory from which biofeedback emerged, it was assumed by the clinical community that that was my field of expertise and, in fact, it became my field of expertise."

Dr. Mark Smith: "Can you give us a brief approach that you use with biofeedback?"

Dr. Howard Glazer: "Sure. When Alex Young first approached me and told me that the women he examined had pelvic floor muscle dysfunctions, at first I was very negative about it, and I told him so. It seemed to be common sense that if you take a patient with vaginal pain and do an examination, you're likely to get a reactive muscle spasm in the area in response to your examination. Frankly, my thinking was that what you're getting is, in fact, an induced phenomena of measurement and not at all what these muscles are really like. I don't know if there's any evidence that these muscles are chronically tense, and if they are, they are also probably reactive as a guiding or splinting against localized pain, rather than etiological.

So I saw some of these women. The women themselves insert a small probe with metallic sensors. When I talk to my patients I say them that it is essentially is an EKG reading of the pelvic floor. So we take those little strips of silver that are normally placed on your chest, and we embed them in a piece of plastic that is shaped in such a way so as to assure that the pieces of metal sit right on top of the pubococcygeal portion of your pelvic floor muscle. Then, basically, the women go into the bathroom, they self insert this sensor, come out fully clothed, and I plug them into a computer. They're lying back in a comfortable lounge chair, rather than in stirrups. They'll actually tell me that these people have tremendous hypertonicity, and the minute I turn on my machine, they're absolutely normal."

Barbara Nesbitt: "They're on the machine and they're normal?"

Dr. Howard Glazer: "Yes. This is a provocative situation where the doctors, by the examination, are provoking the muscle response. They are indeed feeling a hypertonic muscle, but they're also inducing what they are feeling. By definition, it's the old Heisenburg Principle - by virtually measuring something, you change it, so you're can't really measure it in its normal state. This is one of those phenomena."

Dr. Mark Smith: "This is the pubococcygeus muscle?"

Dr. Howard Glazer: "That's correct. We measure the medial portion of the pubococcygeal muscle. Much to my surprise, when I measured these women, the first thing I expected to find was that many of them were, in fact, not hypertonic. Hypertonicity, even chronic hypertonicity of pelvic floor muscle, does not induce vulvar tissue disturbance or vulvovaginal pain syndromes.

On the other hand, when I started to measure these women, 98% of them indeed had hypertonus, unstable, and outright spastic pelvic floor muscles, and that was quite unusual. So I began to think that maybe there really was something to this, and it may somehow have actually been involved in the pain cycle.

Several pieces of data immerged from my tests, and this becomes quite important. Even though the term biofeedback seems to be the catch word that's applied to what I do, I prefer to describe what I do as surface electromyography because what I am doing with my signals is similar to what a cardiologist does with an EKG signal. I have extremely sophisticated EMG technology that allows me to see events in the muscle as fast as one one-thousandth of a second. That allows me to look at recruitment times, recovery times, amplitude, variability, power density, and spectral frequency analysis. What I'm trying to say here is we use really sophisticated ways of looking at muscles. We're not looking at how strong muscles are, and these are not things you can palpate with your hands. I'm not relieving trigger points, and I'm not doing physical therapy. Rather, I am electromyographically normalizing the muscle.

I use a standardized, medically accepted of measuring and normalizing these muscles based on an enormous database and producing repeatable and satisfactory clinical outcomes that I've replicated in different centers around the world. So it is a critical part of what I do to understand that I am not simply exercising these muscles, but I am electromyographically normalizing these muscles. I know exactly what I need to do and what is statistically correlated with pain reduction. And when I accomplish an electrophysiological normalization of a muscle, 50% of the folks I treat become totally asymptomatic."

Barbara Nesbitt: "That's pretty darn good."

Dr. Howard Glazer: "The follow-up is 3-5 years, and they remain asymptomatic."

Barbara Nesbitt: "For up to five years?"

Dr. Howard Glazer: "Yes, it's a three- to five-year follow-up.

Dr. Howard Glazer: "Actually, Raymond Kaufman out of Baylor and I wrote a paper showing about 85% effectiveness in this treatment down at Baylor, where I trained his people how to do it. So we're developing more and more substantiating data on this stuff. Again, my statistics suggest about 50% of the people I treat become totally asymptomatic. There's zero pain and follow-up is now 3 to 5 years on some subset of that population.

Furthermore, every time I see a patient, I ask them to put their recent several days' pain on a scale of 0 to 10, with 0 being none at all and 10 being the worst they've ever had. Based on that and over the treatment sessions I see the patient, at the termination of treatment, the self-reported average reduction of pain is 83%. If 50% of the patients are 100% better and the average is 83% that means if you're not in the 50% of the patients that are 100% better, then the average of the remaining population is only about 63%.

Now 63% for some people may be functionally meaningful, as the difference between being disabled and not having sex versus having sex and functioning may not be functionally meaningful. By no means do I produce a satisfactory outcome in every patient I treat. It's rare that I don't have some contributory benefit for the patient, but I don't want to overstate that I'm able to satisfactorily treat everybody, because that's just not true. I would probably say that maybe 20% of the people I treat do not have a satisfactory outcome - they can not experientially or functionally return to where they want to be. But given that it's a non-invasive treatment, it's not bad.

The average duration of my treatment is nine months. During that nine months and after an initial evaluation by me, patients acquire an intravaginal sensor of their own and an EMG device that they use to monitor their muscles during their exercise. The initial prescribed exercise is twenty minutes, twice a day. As you can see, it is an extraordinarily demanding protocol. Thus, 25% of the people who see me for an initial evaluation and are candidates for this treatment, by EMG readings, and they never come back to me. So there is a significant dropout because of the demands made on the patients. Twenty minutes, twice a day is a really demanding."

Barbara Nesbitt: "That helps you on your end, too, because if you had a bunch of people that weren't doing what you wanted them to do, then…"

Dr. Howard Glazer: "Right. I'm very strict about that, too, and I say exactly that to patients. I say, 'listen, I don't want you going out there and being non-compliant with my prescription and not doing it and saying it doesn't work. If you don't feel you're able to truly commit to twenty minutes, twice a day for an average of nine months, you're better off not doing this.' I don't want people starting this and being non-compliant, and then not getting results. It's not good for me, and it's not good for them."

Barbara Nesbitt: "Would insurance pay for this equipment, Howard? If so, then in all cases, or many, or none?"

Dr. Howard Glazer: "That's an interesting question. Since I have chosen a particular route for myself, I have dropped out of all managed care networks. In fact, I've gone so far as to drop out of Medicare. What that means is that in order for me personally to be covered, these people need to be able to go out-of-network, and they need to have a point-of-service plan. They also need to have referrals from their primary care doctors, and in these cases, it is covered. All the codes I bill are standardized, too. I have my state license and everything else. So the bottom line is that, yes, I do get reimbursed from most insurance companies."

Barbara Nesbitt: "Or the patient does?"

Dr. Howard Glazer: "Right, the patient does. I don't accept third-party payments from patients. I will try to get them letters of medical necessity from the referring physician, and I will get for them citations in the literature proving efficacy. But basically, they're on their own to deal with their insurance providers."

Barbara Nesbitt: "But it's a lot cheaper ultimately then to pay for surgery."

Dr. Howard Glazer: "Right. I see people on average about six times over the course of the treatment. I'll see them initially, maybe two weeks after they've started their exercise then basically once a month, or every four to six weeks. They have to buy their own equipment, but the equipment is federally licensed. It's a prescription device and I only use federally licensed durable medical equipment (DME) distributors. So again, in terms of coverage, if the patient has a DME clause that covers durable medical equipment, they have a bill from a federally licensed DME company who bills them for the equipment and the total cost is $250 per session with me. With an average of six sessions, which is $1500, the equipment is about $425 inclusive of the feedback device and the vaginal sensor from the DME company."

Barbara Nesbitt: "So you're talking around $2,000."

Dr. Howard Glazer: "Right, you're looking at a cost of under $2,000 for a treatment with a pretty satisfactory outcome and likely reimbursement."

Dr. Mark Smith: "Dr. Glazer, are there any other areas around the country that are approaching this similar to the way you are?"

Dr. Howard Glazer: "Yes, even though I have not really promoted this to other doctors. I think I mentioned Raymond Kaufman, out of Baylor, who has had an anesthesiologist pain doctor who is trained to do this. Well, he is getting better results than me, which is wonderful. I trained a guy named Rodney Anderson, too, who is a urogynecologist at Stanford. He also does this work quite well. I have a number of people trained in Australia who do spectacular work and get as good of results as I do. I also have some people trained down in Brazil who do good work. I have a group in Toronto trained at the Pain Center, as well, and I just trained a group of people in Israel who just started to do this.

One of the things that concerns me greatly is that you really need to follow the protocol that includes specifications of the different types of equipment that are satisfactory to be able to do this work. This includes protocols of specific muscle assessment and measurements that must be taken from time to time based on which one assigns the prescriptive homework, if you're going to do this properly. And unfortunately, although about a half a dozen people who have trained with me get the same results as I do or better, there are thousands of people out there who pretend they're doing the same thing but really aren't."

Dr. Mark Smith: "Is there anyone that is doing something similar to what you're doing, with this precise of an approach to it?"

Dr. Howard Glazer: "No, and you know I've been not only not threatened by that, but I've been enormously open to it. I've begged some of these people to please develop their own protocols, to demonstrate efficacy. I have suggested that all of these people who claim that they can do this demonstrate it in a satisfactory manner with clinical research. All you need to do is conduct your clinical work, collect your data on your patients, and show efficacy by subjective measures or by neuromuscular objective measures of change."

Dr. Mark Smith: "What would you advise for the woman who is having problems, say, at the first stage of this, early on? Would you go immediately to this?"

Dr. Howard Glazer: "No."

Dr. Mark Smith: "Could you just give us a very brief approach and offer some advice you would have for women with this condition?"

Dr. Howard Glazer: "My sense is that you need to see your primary care type gynecologist initially for any vulvovaginal pain. If the treatments have not yielded significant resolution within three months, then I think you need to see a vulvar expert. You need to undergo standardized evaluation from a vulvar expert in order to make the diagnosis appropriately because you need to rule out by identification and treatment any dermatologic, infectious, etc. Again, the diagnosis and definition of these conditions is that they are by nature functional only after there are no acute medical conditions.

At that point, I would recommend my treatment as one of the initial ones only because it is one of the more benign ones. It doesn't have to be a 'stand-alone,' one versus the other situation, either. Many of my patients go on tricyclic, start the biofeedback, and use topical palliatives all at the same time, so this is not a 'one or the other' kind of deal.

Also, many of the surgeons I work with tell me that when they identify hypertonicity, they send the patient to me before the surgery to get a much better surgical outcome. When they do surgery on these women with lumpy pelvic floor muscles, they tend to have a higher rate of recurrence. When I've relaxed the muscle, they either get enough symptomatic relief so they don't need the surgery, or they have the surgery and the result is much better."

Dr. Mark Smith: "I think that's a very good approach. We certainly appreciate your input today, Dr. Glazer. I know that this has been a terribly chronic and debilitating problem for a lot of women, which you have very obviously described. We appreciate your time here today."

Dr. Howard Glazer: "Thank you."