Finding Better Treatments for Pelvic Floor Disorders
With age or as the result of injury, the muscles of the pelvic floor can weaken, causing pelvic organs to shift and often leading to a range of uncomfortable and even distressing symptoms. Estimates suggest that by the year 2050, 44 million women in the United States will be facing at least one of several related conditions characterized by such signs. Together, they are known as pelvic floor disorders (PFDs). For National Women's Health Week, the NICHD is raising awareness about these common but often hard to discuss conditions.
NICHD grantee Matthew D. Barber, M.D., M.H.S., sees patients every day who are looking for relief from one or more pelvic floor disorders. These disorders, which often include urinary incontinence and fecal incontinence, can curtail a normal life and isolate the women who have them.
As the director of the Pelvic Floor Disorders program at the NICHD, medical officer Susan F. Meikle, M.D., M.S.P.H., often receives emails from women seeking help and advice. She spends much of her time planning and overseeing studies that will lead to better ways to prevent and treat pelvic floor disorders.
In the interview below, Dr. Meikle, an obstetrician/gynecologist (OB/GYN) and the program director of the NICHD-funded Pelvic Floor Disorders Network (PFDN), and PFDN researcher Dr. Barber, a urogynecologist and professor of surgery at the Cleveland Clinic, discuss pelvic floor disorders—what they are, how they affect people who have them, and how they are treated. Drs. Meikle and Barber also talk about a PFDN study that is helping advance treatment for one type of pelvic floor disorder called pelvic organ prolapse.
Describing Pelvic Floor Disorders
In pelvic organ prolapse, muscles supporting the pelvic organs weaken. The organs often shift, fall, or protrude from the body.
Q: What is a pelvic floor disorder?
Dr. Meikle: It's really a group of conditions that affect the function and integrity of the pelvic floor, which is that hammock or sling of muscles and fibrous tissues that support the bladder, the uterus, and the rectum. So when this supportive sling weakens, the position of the organs can change and even protrude outside the vagina, leading to functional problems. This weakening of the sling can be due to multiple factors like genetics, body weight, and situations like chronic coughing or childbirth that put a strain on the pelvic floor.
Dr. Barber: To add to what Susie said, it's really a constellation of different conditions that overlap with one another. One of the most common pelvic floor disorders is pelvic organ prolapse, which as Susie mentioned is the protrusion of the pelvic organs through the vagina.
Another common pelvic floor disorder is urinary incontinence, the type of incontinence that women might develop when they leak urine when they cough and sneeze or do physical exercise, and the type of urinary leakage that can be associated with what's called an overactive bladder, where you're often having to rush to the bathroom, have a strong sense of urgency to urinate, and may not get to the bathroom in time.
Another common pelvic floor disorder would be bowel control problems; that is, fecal incontinence.
Other conditions that we see that are part of this group of disorders include emptying problems of the bowel and bladder, so not being able to empty the bladder well or not being able to empty the bowels without constipation, for instance. All of these things together make up the entire group that we call pelvic floor disorders.
Q: Can you describe the symptoms?
Dr. Barber: It really depends upon which of the conditions you have. And I guess the other important thing we would say is when one person has one of these pelvic floor disorders, it's not uncommon at all that they have symptoms of one of the other disorders as well.
So, for instance, in a woman who has pelvic organ prolapse, the most common symptom is that they see or feel a bulge coming from the vagina. But it would not be uncommon at all that they also complain of difficulty emptying their bladder, or urinary leakage, or difficulty emptying their bowels, or also having problems with bowel control.
Pain can occur, but it's generally uncommon with these conditions. It's more often that with, for instance, prolapse, you're feeling a bulge or pressure in the vagina or a heaviness in the pelvis, along with the other associated symptoms like leaking or difficulty emptying.
Q: How many women are affected?
Dr. Meikle: Well, we looked at a really well-done national survey, and it wasn't surprising to us, but almost a quarter of women between the ages of 20 to 80 have at least one pelvic floor disorder—and often more than one. That means the number of U.S. women currently affected is somewhere around 28 million. And these conditions increase with aging. When you project those numbers out over the next few decades, it means the number will rise to about 44 million women by 2050. (Read Roughly one quarter of U.S. women affected by pelvic floor disorders.)
So this is a public health issue, and a cost issue. The quality of life of women and mothers and how they deal with their pelvic floor disorder affects the family, too. It's a very multi-faceted problem.
Pelvic Floor Disorders in the Clinic
Q: How frequently do you see pelvic floor disorders in your practice?
Dr. Barber: Well, I'm a specialist, and my entire practice centers around treating and taking care of women with pelvic floor disorders. This is a condition that is common enough that general family practitioners and general primary care doctors will see patients with this condition. Often it's being taken care of by general OB/GYN doctors and general urologists, depending on the problem and depending on the nature of their practice.
Q: What do we know about why they occur?
Dr. Barber: We're getting more and more information about that, but there's a lot we don't know. A combination of many things causes it. The biggest ones being, though, the older you get the more common these conditions are. The more vaginal childbirths you've had, the more likely you are to have one of these conditions. And the heavier you are, the more likely you are to have one of these conditions.
We also have an increasing understanding that there is a genetic component, that it does run in families. And that there may be certain genes that are related to how the body responds to pregnancy and childbirth that may predispose some women to get it while others do not.
And then there's lifestyle factors like, do you have a job where you're doing heavy lifting versus a sedentary job, where the risk of the pressure on the pelvic floor may be less?
Q: How do you treat pelvic floor disorders?
Dr. Meikle: I think you can group the treatments into nonsurgical and surgical perspectives. And the mainstay of nonsurgical treatment for pelvic floor disorders has been pelvic floor exercises. Many women have heard of Kegel exercises, which are contractions to strengthen the pelvic floor.
But there's another level of pelvic floor exercise training where physical therapists, nurses, or other professionals who really have an extensive knowledge of the pelvic floor muscles—and there are many small muscles in the pelvic floor—can customize the training sessions.
NIH has funded research on other ways to strengthen the pelvic floor and other alternative therapies, like yoga and hypnosis, to treat symptoms from overactive bladder, for example.
There's a wide range of medications, mainly to treat urinary incontinence. And those can be oral or they can be in patches. A newer treatment is the injection of Botox into the bladder to relax that bladder muscle so the spasms go away and there's less incontinence.
Pessaries are another option. Those are generally plastic rings inserted into the vagina to provide support for the pelvic organ prolapse conditions and some of the types of incontinence conditions.
So there is a pretty big array of nonsurgical treatments that might provide relief from the symptoms. I hope women realize they can get help, maybe going to a generalist or some other type of health care provider. And if they can at least take that first step to discuss their symptoms, then there's some opportunity to explore these treatments.
Q: What are some of the surgical interventions?
Dr. Barber: So, surgery tends to be, for all of these conditions, the mainstay of therapy for severe disease. Surgery is also the main therapy for women who have gone through one or more of the nonsurgical options and didn't get adequate relief.
The surgeries that we offer will depend on the condition. So, if we're talking about what we call "stress incontinence"—urinary leakage with coughing, sneezing, laughing, exercising, and that type of thing—the mainstay of surgical treatment is something called a sling procedure, or a midurethral sling. The midurethral sling has been widely studied and shown to be a safe and effective procedure.
In patients who have overactive bladder, as Susie mentioned, we now have Botox as an option, which can be done as an office procedure.
There's also a neuromodulation device, much like a pacemaker for the bladder. In fact, one of the PFDN studies that we're participating in now is comparing Botox to the neuromodulation device for overactive bladder in people with severe urge urinary incontinence.
When we get to pelvic organ prolapse, pessary treatment is the only effective treatment other than surgery. In terms of the surgery, there are a number of different approaches that a surgeon might choose to treat the patient. And it will depend a bit upon how bad the prolapse is, what the extent of protrusion is, what parts of the vagina and pelvic organs are protruding, and what other symptoms the woman has.
Research to Advance Treatments for Pelvic Floor Disorders
Q: Can you give a brief description of the PFDN study findings that were recently published in the Journal of the American Medical Association (JAMA)1?
Dr. Barber: So this study was the result of the OPTIMAL trial. OPTIMAL is an acronym that stands for Operations in Pelvic Muscle Training in the Management of Apical Support Loss.
And this was a study that first started enrolling patients back in 2008, and over the next 4 years, enrolled 408 patients from nine different sites. We had eight sites in the network and an additional site that enrolled patients. These patients underwent surgery, and we followed them for 2 years after surgery.
Q: And you were comparing two surgical techniques to find out whether one was better than the other?
Dr. Barber: Yes. This trial actually was trying to answer two very important questions in women who were undergoing surgery for pelvic organ prolapse who also had stress urinary incontinence.
The first was to compare two very commonly performed operations to suspend the top of the vagina in women with uterine or apical prolapse. These two procedures are both done through the vagina, so they're transvaginal procedures. And they're probably the two most common operations for this type of prolapse that are performed worldwide. So we wanted to answer the question, what is the best transvaginal operation to suspend the top of the vagina when it's prolapsed, without the addition of mesh?
Even though the two procedures are so commonly performed, they had never been directly compared in a randomized clinical trial before. The answer will help lay the groundwork for other studies, as well as to provide crucial information to the practicing physician and surgeon.
In sacrospinous ligament fixation surgery, vaginal tissue is attached to ligaments in the back of the pelvis to keep the vagina from falling. This approach was one of two surgical treatments for pelvic organ prolapse compared in a recent study.
The two surgical procedures that we compared were the sacrospinous ligament fixation and the uterosacral ligament suspension. These are both operations done to suspend the top of the vagina after prolapse of the uterus or prolapse of the top of the vagina in someone who has had a previous hysterectomy. These are two common operations we would do for women who we've chosen to treat though the vagina, but not using mesh.
In the sacrospinous ligament fixation, the top of the vagina is sutured to one of two sacrospinous ligaments that are in the back of a woman's pelvis. So it's a unilateral suspension. And then in the uterosacral ligament suspension, the top of the vagina is sutured to ligaments that are more in the middle of the pelvis, and it's attached bilaterally on both sides.
In this particular study, with this particular type of prolapse, we compared the two procedures through a randomized clinical trial to see which worked better and what the relative risks and safety concerns might be. (Read Two surgeries for pelvic prolapse found similarly effective, safe.)
Q: And what was the outcome?
Dr. Barber: What we found was that, overall, the efficacy for these two procedures were similar in that 2 years after surgery, the risk of a patient developing symptoms again, or having the vagina protrude outside the vaginal opening, or needing another operation or other treatment like a pessary for prolapse, was not significantly different between the two procedures.
Overall, the risk of complications or adverse events was also similar between the two procedures, although the types of adverse events did differ depending on the procedure.
Researchers also investigated the effectiveness of uterosacral ligament suspension, in which the vagina is sutured to ligaments located more in the middle of the pelvis.
For instance, in women who received the uterosacral ligament suspension, because of where it's suspended, it is close to the tube that connects the kidney to the bladder called the ureter. So the risk of having kinking of the ureter was higher in that group than in the sacrospinous ligament fixation group.
On the other hand, in women who had sacrospinous suspension, they were more likely to develop buttock pain after surgery because of the relationship between some of the nerves to the ligament where things are suspended.
So what we found was that overall these two procedures have similar efficacy and adverse events. And this, I think, helps the clinician in that if you are comfortable with one of these two operations, it gives you confidence that you can tailor the operation to the patient, depending on which of the two suspensions you think makes the most sense for her anatomy.
(The JAMA video interview with Dr. Barber, "Two surgeries that may help correct a common female condition have similar outcomes," provides further information.)
Q: What did you learn about the importance of pelvic floor exercises?
Dr. Meikle: So, this was a coached set of exercises, one-on-one, individualized pelvic floor muscle therapy. And what we mean by individualized is that the coaches, the physical therapists who carried out this study, would be able to customize the program so that they would maximize the chance of improvement. So, in other words, they wouldn't overtire someone who had muscles that were weaker to begin with.
Half of the women received exercise therapy and half did not. The ones in the therapy group received about five or six sessions. There were one or two sessions before the surgery, so they could really isolate and identify those small pelvic muscles that we were trying to strengthen, and then about four sessions after the surgery.
It turns out that, really, there was no additional benefit for the women who had the pelvic muscle therapy compared to those that didn't when they underwent this surgery. So, in this group of women for these surgeries, it didn't seem to be worth the cost and effort to include this type of recovery program with surgery.
Q: Why do you think the exercises were not effective?
Dr. Barber: Well, I think it is a couple of reasons. All of the women got surgery that we know to be effective, and also got a sling for their urinary incontinence, and they got significant benefit from those. So to show an additional benefit on top of that was hard to do, I think. I think it's when you're already getting relatively good results, to get an incremental benefit requires a pretty good treatment effect, which these just didn't have.
And while the women reported that they were doing their exercises, what we don't know is, were they doing them the same way that they were supposed to be doing them, and were they doing them as often?
But we shouldn't take away from the study that the exercises are not effective. They are effective for primary treatment for pelvic floor disorders.
Reducing Pelvic Floor Disorder Risk
Q: Are there things that women can do to reduce the risk of pelvic floor disorders?
Dr. Meikle: There are a lot of different contributing factors that add up a little bit here, a little bit there to the condition. And that's not unusual for a lot of medical problems. Prevention of undesired medical conditions often revolves around the basics: keeping a healthy weight, exercising, eating healthfully, and seeking help when the conditions are on the more mild side.
I don't think that we have enough information yet to say specifically, if you did Kegels every day that you're going to prevent these conditions. We're going to work on the prevention, but we don't have that information yet.
Dr. Barber: And the other important point is that there's a lot more than obstetrical factors that contribute to this. Women who've never had babies can get these problems. Many women have multiple babies and never get these problems. So it's the whole multifactorial nature and trying to understand how they all play together that we need to figure out.
- Barber, M. D., Brubaker, L., Burgio, K. L., Richter, H. E., Nygaard, I., … Meikle, S. F.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (2014). Comparison of two transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA, 311(10), 1023–1034. PMID: 24618964 [top]