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Bacterial Vaginosis and Trichomoniasis: Screen, Treat, Prevent
Slide 1: Screen, Treat, Prevent - a proactive approach to patient management
In this presentation, Dr James McGregor will address the importance of taking a proactive approach to bacterial vaginosis (also known as “BV”) and trichomoniasis.
Too many women and their health care providers fail to appreciate the significance of these two conditions. The obvious signs and symptoms of BV and trichomoniasis are often played down as “nuisance” complaints. However, the evidence shows that BV and trichomoniasis must be taken seriously for as a health risk.
Recent advances in diagnostic technology allow clinicians to quickly and conveniently screen patients for bacterial vaginosis and trichomoniasis, make a prompt and accurate diagnosis, and initiate appropriate treatment without delay.
Throughout this presentation, and again at the conclusion, you will have the opportunity to request product samples, additional information and follow-up from your local Genzyme Diagnostics representative about the OSOM Trichomonas Rapid Test and OSOM BV Blue Test, by convienently clicking on the button at the bottom of the slide screens.
This webinar has been made possible by educational funding from Genzyme Diagnostics.
Slide 2: James A. McGregor, MDCM
Hi. My name is Dr. Jamie McGregor. I’m a professor of obstetrics and gynecology here at the Keck School of Medicine at USC here in Los Angeles; and we’re going to talk today about bacterial vaginosis and trichomoniasis.
We’ll be emphasizing an STP or Screen Treat Prevent approach. We’ll see that these are common causes of vaginal complaints. Indeed they are amongst the commonest causes why women see care providers. The symptoms are irritation, discomfort, pain, discharge and certainly odor.
We’ll see that some of the sequelae of these lower reproductive tract infections include upper genital tract infections involving the uterus, that’s pelvic inflammatory disease; infertility from salpingitis; complications of pregnancy and that includes pre term birth, pre term rupture of membranes, chorioamnioitis, and indeed infection of the baby.
We’ll see that these infections which also may be combined can increase the risk of both HIV transmission and reception.
So these are clearly important clinical conditions for which we must develop strategies for diagnosis and treatment.
Slide 3: BV and “Trich” important health issues
In over half of patients with bacterial vaginosis or trichomoniasis are actually asymptomatic and the diagnosis actually depends upon clinical acumen, use of the tools that we have including microscopes - if that’s available. But we’ll see that point of care diagnostic products are also of critical importance in making the diagnosis of bacterial vaginosis.
There are barriers, barriers to care for women with lower reproductive tract infections. These include us not understanding the urgency of the situation and the possible complications.
Another barrier is lack of an easy diagnostic process and products. Many of us don’t have working microscopes in our clinics or our offices; and so a point of care test is critically important for the care of these women.
I’ll be suggesting that a Screen Treat Prevent - STP Approach – is the way to go. And I’ll suggest that in fact it doesn’t apply just for bacterial vaginosis or trichomoniasis, but also for other lower reproductive tract infections which can spread into the upper tract of the uterus and the fallopian tubes.
Slide 4: Differential Diagnosis of Vaginitis
Here’s a list of common causes of vaginitis and sometimes vulvitus. It’s not a complete list, but at the top is bacterial vaginosis which is actually the commonest.
Bacterial vaginosis exists in 5 to 30 percent of most populations. And at the bottom is trichomoniasis. But trichomoniasis is actually quite common too in a variety of other populations.
Slide 5: Trichomoniasis
Here’s a picture of trichomoniasis. This is actually taken in culture, which is an excellent way to make the diagnosis, if it’s actually available. You can see the trichomoniasis is a single cell protozoa. Indeed, it’s the commonest sexually transmissible protozoa in the world. So in fact, this is a very common organism.
In the United States, or North America, or in Europe, it varies greatly in different populations. And so you have to know who you are caring for and how common it is in separate populations. But it’s certainly, when it’s symptomatic, it needs to be examined for in particular.
Slide 6: Bacterial Vaginosis
This is a picture of bacterial vaginosis taken through the microscope. You can actually see that under low power, it actually appears like there are squamous cells in the vaginus, so it’s a superficial infection.
And you can see lots of different kinds of bacteria that are involved. Some of these include mobiluncus, but now we understand that a great variety of different kinds of bacteria, especially anerobic bacteria are involved.
The new emphasis is being placed on different kinds of microplasmas or urea plasmas which wouldn’t show up on a gram stain at all. Overall, there’s different groupings of micro-organisms that are important in bacterial vaginosis.
Slide 7: Epidemiology: Trichomoniasis
In terms of the epidemiology of trichomoniasis, this is the commonest protozoal sexually transmissible infection. Millions of people have trichomoniasis. In some populations, it’s just 1% of the population. In other populations it goes to 20 to 30 plus percent. So a variety of different circumstances in each population or women who are at risk.
Trichomoniasis increases the risks of other infections, and that includes bacterial vaginosis. Importantly in the world, trichomoniasis and BV amplify the risks of giving or acquiring HIV infection. So this is certainly important in terms of public health in preventing reproductive tract origin infections of HIV.
Slide 8: Epidemiology: Bacterial Vaginosis
In terms of the commonest causes of vaginal discharge and discomforts that we, as practitioners would see is bacterial vaginosis. We use to think it was yeast, but now we know that candidiais, which is certainly important, has actually been replaced by bacterial vaginosis as the commonest cause of why women see practitioners for vaginal complaints. Bacterial vaginosis exists in 5 to 30 percent of most populations, when diagnosed on a gram stain or using other kinds of tests. This is actually quite common.
There are certainly susceptibility factors which are not completely understood – not only for acquiring bacterial vaginosis, but having complications from bacterial vaginosis. Some of these may be genetic; and some of these may be associated with other kinds of infections or micro-organisms which are also present in the reproductive tract of women with bacterial vaginosis.
In terms of trichomoniasis, this is also associated with other kinds of infections, as I said, and that includes bacterial vaginosis itself. Other factors, in terms of the lives of women certainly influence these conditions. IUDs – using an IUD is a common predisposition for bacterial vaginosis and this needs to be looked for.
Slide 9: Features Common to Trichomoniasis and BV
Features that are common to both trichomoniasis and bacterial vaginosis are that they’re lower reproductive tract infections; and in some populations, actually quite common. They’re mainly, or at least 50 percent of the time, asymptomatic. But in fact, only about half of women actually complain to their practitioner about the signs and symptoms of these conditions.
It may be that women are embarrassed or don’t recognize that their discharge or odor is associated with an abnormal condition. This is certainly evident to experienced practitioners. So over half of these conditions are asymptomatic. Critically, both of these conditions are infections; appear to act like sexually transmissible infections.
Slide 10: Trichomoniasis and BV Sequelae
Clearly trichomoniasis is a sexually transmissible infection – a classic sexually transmissible infection. It used to be called an STD, but it’s actually an infection – STI.
Bacterial vaginosis appears to be different. As I said before, it’s more of an ecological change within the reproductive tract where there are many more varieties of bacteria that replace normal lactobacillus which tend to be protective; and also much higher inoculums or population densities of these abnormal bacteria.
Both of these can be shared between male and female partners and also amongst women who have sex with women.
Both trichomoniasis and bacterial vaginosis increase the risk of transmission, and also reception of HIV infection. So in many studies, what’s been done is to actually screen and treat for both bacterial vaginosis and trichomoniasis; and, other common reproductive tract infections; and, treat them in an effort to actually reduce the risks of HIV transmission.
Both of these infections also increase the risk of post operative infections. If women have a procedure, such as a hysterectomy, or D&C or a termination, these conditions increase the risk of post operative infections; and the studies have been done showing that if you screen and treat for reproductive tract infections such as trichomoniasis and bacterial vaginosis, you can actually reduce the risks of post-operative infection or febrile morbidity.
Importantly, bacterial vaginosis and trichomoniasis, by themselves, and especially in combination with other conditions, increase the risk of ascending infections in pregnancy. This is associated with now what’s called late miscarriage, which is loss of the pregnancy before viability, or 24 weeks, as well especially, as early preterm birth.
The preterm births that we are talking about are after 24 weeks and before 32 weeks. This is associated with the highest morbidities and mortalities in terms of the children who are born in these situations. The intermediate step appears to be chorioamnioitis – chorioamnioitis. And now we understand that chorioamnioitis can also be associated with fetal or perinatal infection. And one of the complications of that is not just the prematurity, but also specific infection, inflammation of many organs within the child.
All of this can be prevented by diagnosing and treating appropriately, bacterial vaginosis, trichomoniasis; and other abnormal microbial lower reproductive tract infections in pregnant women or women who are preparing for pregnancy.
In trichomoniasis, it’s often combined with bacterial vaginosis. Cervical neoplasia, cervical cancer, can be infected with both bacterial vaginosis and trichomoniasis. Indeed, there is some data that suggests that bacterial vaginosis and trich, as well as other infections may increase the risk of cervical neoplasia.
Slide 11: Trichomoniasis: Possible Sequelae
Trichomoniais increases the risk of upper reproductive tract infection that’s - endometritis, that’s PID, salpingitis– that’s associated with tubal infertility.
So pelvic inflammatory disease is associated with trichomoniasis with ascending infection in both the lining of the womb as well as the fallopian tubes.
Post operative infections are increased with trichomoniasis. It doubles the risk, doubles the risk of post operative infections – a variety of kinds. And you can actually get rid of the excess risks by screening and treating ahead of time.
Trichomoniasis, likely in combination with other infections, including bacterial vaginosis, chlamydia, other sexually transmissible infections can amplify risks of late miscarriage, infection linked late miscarriage – that’s before 23 weeks, before viability, especially early preterm birth and rupturing of membranes. And, it’s also associated with chorioamnionitis; and thus infection of the baby’s placenta and the baby him- or herself.
This increases risks of organ damage, including the central nervous system, as well as the lungs, in pregnancy. And now we have studies which show that you can systematically decrease the risk – decrease the risk of these complications by screening and treating for all of these infections – systematically screening and treating for trichomoniasis, as well as other infections.
Slide 12: BV: Possible Sequelae
Bacterial vaginosis is associated with some specific sequale, as well as specific problems. These include upper reproductive tract infection, again that’s endometritus and salpingitis that’s pelvic inflammatory disease. Bacterial vaginosis is associated not only with infertility, but with also atopic pregnancy – not only infertility, but atopic pregnancy.
In pregnancy, bacterial vaginosis is associated with increased risks of ascending infection often times with bacterial vaginosis associated micro flora actually up inside the bag of waters.
Amongst patients with infection already of amniotic fluid, when there’s a genetic amniocentesis done, many of those women go onto to have a preterm birth actually before the 30 week – 30 weeks of pregnancy. So this is a new area which in the last decade has been increasingly understood. Bacterial vaginosis also increases the risks of post operative infection. Studies have now shown that you can actually screen and treat for bacterial vaginosis right before an operation, like a hysterectomy and cut the rate of post operative infection in half…so post operative infections… …That is not shown to be the case for inserting an IUD or other kinds of simple operations, but for hysterectomy, that’s clearly the case.
Slide 13: Traditional Diagnostic Methods - BV
Diagnostic techniques for both bacterial vaginosis and trichomoniasis are not so simple when you really think about it. In terms of bacterial vaginosis, most of us would use the Amsel’s criteria; which is pH. Specifically, with Amsel’s criteria - Amsel was a clinician at the University of Washington, now over 20 years ago; and these are clinical criteria - and the most sensitive of these is actually pH.
A pH over 4.5 or 4.7 in some centers is a sensitive way to make the diagnosis of bacterial vaginosis, but it’s not specific.
An amine odor – we won’t use the word “fishy” but an amine odor which is most specific. The presence of clue cells, but you need a working microscope to see the clue cells; and a milky discharge – a milky discharge which you can see on the surface of the vagina, sometimes the vulva and certainly the cervix.
What you need is a working microscope to see the clue cells and that’s over 20% of the cells that you see in the vaginal wet prep and what you can actually see is gardnerella, mobiluncus, (and) other kinds of bacteria actually lining up on the edge or on the surface of desquamated vaginal cells.
The other criteria is actually the presence of a gram stain. This is Nugent’s criteria or Spiegel’s criteria. And I don’t think this is actually going to be available in the future from the many labs which are moving more towards point of care tests, as well as not doing direct smears in a hospital or clinic laboratory.
Slide 14: Clue Cell
Here’s a picture of a positive clue cell. This was done with a gram stain in the lab or the office. You don’t get to see the positive gram stain, but here are the micro-organisms and they are all stacked up on the surface of this desquamated cell from the vagina, as well as on the edge. And this is one of the criteria for Amsel’s clinical criteria and you need three of these four. So basically, this is the critical one in terms of clue cells and you need a working microscope for this.
Slide 15: Nugent’s Criteria: Gram Stain Assessment
The Nugent’s criteria, which is derived from other kinds of scoring systems, involves looking for large lactobacillus, looking for small gram negative rods which are commonly gardnerella or anerobic bacteria, such as bacteroides; and small curved gram variable rods that look like sea gulls and this is mobiluncus. Now we know that it is much more complex.
Slide 16: Traditional Diagnostic Methods: Trichomonas
Diagnostic techniques for trichomoniasis – there are multiple. The culture is the Gold standard. It’s not completely sensitive, but it’s certainly completely specific, since it’s the Gold standard. But it’s not really available in many centers.
Nucleic acid probes are also helpful. And the detection of trichomoniasis on a wet mount actually requires a working microscope and some skill. The diagnosis in terms of wet mount has been as low as 40%. So the microscope has to be available; and, you have to know how to use it to get better results.
And then of course, both bacterial vaginosis and trichomoniasis can be noted on PAP smears or cytological smears; and, this is an area of contention with some analysis of the data suggesting that PAP smear diagnosis of both trich and BV are quite good - and others really dismissing it. So we need a point of care test for both bacterial vaginosis and trichomoniasis.
As we get into the next age, in terms of the laboratory, that will be less and less available and in many clinicians’ offices. So what we really need is a point of care test that works in terms of biomarkers, a product of the micro-organisms such as sialidases. In fact, this is available.
Slide 17: Symptoms of Vaginal Infections
This is a slide which puts everything together. We’re not going to go thru this in terms of each individual parameter. But it’s critical to note that the clinical criteria for bacterial vaginosis or trichomoniasis aren’t so easy to fulfill; and, what we need is a biomarker test or point of care test, that can easily and rapidly make the diagnosis with sensitivity and specificity for both of these conditions.
Odor in the normal situation – there is actually an odor but it’s a normal odor. It’s not unpleasant – it’s not amine odor or musty. Yeast sometimes can smell like yeast; and trichomoniasis can sometimes be associated with a positive amine odor – maybe that’s because of bacterial vaginosis also being present.
In terms of discharge, the normal discharge is clear or milky and is not associated with irritation. In bacterial vaginosis, it’s thin, milky or grey and usually increased and runny. In terms of yeast, of course that classically looks like cottage cheese and is thick and curdy.
Trichomoniasis by itself is different. It looks inflammatory. There are bubbles and often times, it’s highly irritating with a strawberry cervix, reddened cervix with yellow pearly discharge.
In terms of discomfort, bacterial vaginosis, again maybe asymptomatic, but is associated with itching, burning and sometimes greater discomfort. Yeast, when it’s symptomatic, is certainly associated with puritis or real itching. Same thing is true of trichomoniasis with its irritation.
There are treatments for all of this which the CDC and other organizations recommend. And these are well known, and we’re not going to go into each of these but normal patients don’t need any treatment. Certainly metronidazole and clindamyacin are useful in terms of bacterial vaginosis; and for trichomoniasis, metronidazole,and now tinadazole is certainly also important. Tinadazole has been used normally in Europe for trichomoniasis.
So the partner needs to be treated in the occurrence of trichomoniasis. This can be done – you can see the partner yourself and prescribe the metronidazole or the tinadazole or he can be referred to a clinic or another clinician. But it has to be done, or your patients will get the trichomoniasis back.
Slide 18: Diagnosis of Trichomoniasis: Practical Challenges
Practical challenges in the diagnosis of trichomoniasis are that we don’t really have microscopy skills. I quoted an article, that I helped with, where we found a sensitivity of using a microscope, of making the correct diagnosis of trichomoniasis as low as 40%. So clearly, we need other kinds of mechanisms, other kinds of technologies.
In terms of the diagnosis of trichomoniasis, there are also important clinical and practical challenges. It takes several days to get the culture back and patients want to know right away what’s going on. DNA probes are certainly useful, but we’re talking about first generation DNA probes. A better test which includes PCR, which have been developed in the lab, are not commercially available.
Slide 19: Diagnosis of BV: Practical Challenges
In terms of the diagnosis of bacterial vaginosis, there are some important clinical challenges. The Amsel’s criteria, although they’re certainly robust, they require use of a microscope which is no longer available in many offices and clinics; and it has to be workable. So this is a critical problem.
Another critical problem is that microbiological labs are now going away from making microscopic diagnosis in gram stains. They are moving more towards molecular approaches; so the Nugent’s criteria, the Speigel criteria will no longer actually be available in many centers that used these.
Slide 20: Diagnosis: Other Issues
There are other issues relating to diagnosis which are also important. Remember that most of these infections - many of these infections - go undiagnosed. Patients have these clinical conditions, but don’t complain. So we need something that maybe is an easy, point of care test which will have rapid, accurate diagnostic abilities.
Many health care providers, we know this- many health care providers do not appreciate the health risks that women, especially have from reproductive tract infections. This is both in the non pregnant state and certainly during pregnancy. We certainly don’t fully recognize what’s at risk by having ascending infections – by having abnormal micro-organisms in the lower reproductive tract and ascending infections into the endometrium, the lining of the womb, as well as the fallopian tubes, in non-pregnant women.
And we don’t appreciate the adverse effects in terms of ascending infections in pregnancy – which we just talked about. So we reproductive tract care providers, patient care providers - need to understand what’s at risk in terms of the patient’s life potential – in terms of the reproduction – in terms of pregnancy and the family formation.
Slide 21: Tone, Terms, and Attitude Adjustments
We don’t recognize that for many patients, this is an embarrassing moment. We don’t recognize that it actually takes patient gumption as well as resources and time to call up and make an appointment and get to be seen in an appropriate manner.
I think actually the tone and the terms we use, the language we use, are important in how we care for women and men with reproductive tract infections.
We know about the consequences; we know about actually potential liabilities. I think that actually what we need to do is to pay attention in terms of the clinical setting so as to facilitate the best of care in terms of diagnosis, treatment, and indeed prevention.
Some of the words we use are not helpful. I would suggest one of those is STD – or sexually transmissible disease. I think that it’s actually now sort of trite and in wide spread use. But what we’re really talking about is STIs - or sexually transmissible infections where you get this condition from one person to the next. That’s of course not the case for bacterial vaginosis, which appears to be a micro ecological disorder.
Don’t use the words foul or fishy which are certainly negative because who would want to have a fishy odor – who would want to have a foul odor?
Use words like amine odor because actually the kind of odor we are talking about is actually an amine odor from triethylamine mainly. So use an amine odor as the best descriptor.
Don’t use words like atrophic vaginitis. Atrophic means certainly we’re wasting away. And that’s certainly not the case. So again do say sexually transmissible infection or STI.
Do say low estrogen changes for BV micro ecology. And use the term that is accurate which is lower reproductive tract infection or reproductive tract infections in general.
I think that actually this advances how we care for patients and how we cast a diagnostic therapeutic spell which is part of the STP – Screen, Treat, Prevent approach.
Slide 22: Proactive Practice Policies
Our staff are important as well. It’s not just the care providers, it’s the staff and everyone who is caring for the patients. How we use language and how we are accepting; and how we answer the phone; and how we get a rapid appointment instead of an appointment for vaginal discharge with irritation for two weeks, but actually to see the patient that day. Those are certainly important.
Questions for staff to ask are: Do you have a reproductive tract infection or symptoms? Are you having any reproductive tract symptoms such as itching, burning or discharge? Those are negative and accurate.
Have them use the terms: Do you need to come in because you are having a reproductive tract discomfort? Most likely, they’ll say yes, and would like to be seen that day – that day.
This is not a phone call diagnosis. This is itching, burning, discharge, odor and it needs to be seen promptly to begin with – especially in the setting of pregnancy, or where there is other reproductive tract sequelae which may occur.
Certainly we here in Los Angeles are worried about liability issues. And seeing the patient promptly; making accurate diagnosis; and, giving a specific treatment recommended by the CDC are certainly ways to go to reduce liability.
Slide 23: Diagnosis: Ideal Screening Methods for Trichomoniasis and BV should include
So overall, the STP or Screen, Treat, Prevent approach means to understand what’s going on – what’s at risk; and, understand the personal and public health aspects of each of these kinds of infections.
You’ve seen that these are complex, but in fact, we need to make the diagnosis right the first time. But women want to have the diagnosis of vaginitis done correctly the first time and the treatment be given correctly the first time.
We want to use tests with good sensitivity and good specificity. No test is completely accurate – we’ve already discussed that in some comparative detail. We want to have it easy to use, easy to read in clinical practice. A point of care test that actually comes back when the patient is still there.
It has to be affordable and given the costs of the complications of these infections – has to be affordable in terms of both everyday clinical practice, as well as public health practice.
And the prevention part of this needs to be a message that we need to talk about at another time.
But clearly patients, as well as practitioners, need to know the facts of life in terms of how these infections and conditions are caused; and what we can do about to mitigate or reduce sequelae and reduce the damage that they do.
Slide 24: “Intellectuals solve problems, geniuses prevent them.” - Albert Einstein
So to sum up, here’s a picture of Einstein reminding us of the importance of prevention. And what we’re getting to is primary, as well as secondary prevention of these common reproductive tract infections – bacterial vaginosis and trichomoniasis.
We need to emphasize new diagnostic tests. Tests that are specific, sensitive, thus accurate; easily available, affordable, time sensitive – that means 10 minutes or less- CLIA waived which means anyone in your office or clinic can do these tests, so that’s pretty important; and highly useful for women who can come in and be seen rapidly and efficiently, get the diagnosis right the first time, get the treatment right the first time and prevent the sequelae. When we prevent the sequelae, we reduce not only the patient’s suffering but liabilities, patient costs and costs to society. So, thank you very much.
Slide 25: OSOM® Trichomonas Rapid Test
OSOM® Trichomonas is the only CLIA-waived rapid test to diagnose this sexually transmitted infection. More sensitive than wet mount, this test provides easy to read results in 10 minutes or less, without the need for a microscope. And it is included in the ACOG and CDC Guidelines as an alternative to wet mount.
Slide 26: Table 4.
Diagnostic methods for trichomoniasis in women Since the OSOM® Trichomonas test detects the antigen, it does not require the organisms to be motile, as does the wet mount. As a result it is more sensitive and easier to read than wet mount. Since is it CLIA-waived, anyone in the office can perform the test improving the workflow in your practice.
Slide 27: OSOM® BVBLUE® TEST
OSOM® BVBLUE® is the only CLIA-waived rapid diagnostic test for Bacterial Vaginosis. It is more sensitive and specific than wet mount. With a vaginal swab, and less that 1 minute hands-on time, this test detects elevated sialidase enzyme produced by the 4 most common bacterial pathogens associated with BV. Results are easy to read – solution turns blue or green indicates a positive…yellow indicates a negative.
Slide 28: Competitive Methods
OSOM® BVBLUE® is more sensitive than these 3 competitive methods. It does not require a microscope to search for CLUE Cells. And it is CLIA-waived, freeing up your valuable time.
Slide 29: Next Steps
For more detailed information, or to view videos of the OSOM® rapid tests being performed in real time, please click on the links in this slide.
Slide 30: Thank you for your participation!
Thank you for your participation in this presentation of “Bacterial Vaginosis and Trichomoniasis: Screen, Treat, Prevent a proactive approach to patient management” Please click on the gold button at the bottom of this slide to request samples or to be contacted by a Genzyme Diagnostics representative about how you can implement the benefits of OSOM® Trichomonas Rapid Test, or OSOM® BVBLUE®, into your practice.