Good evening. Welcome to tonight's webinar. My name is Dr. Christina Lewicki-Kaup, and I'll be moderating for today's webinar. Before we begin, I want to share with everyone that we'll take questions at the end of the webinar, but you can submit them at any time by typing them into the question box on the left-hand side of the event window. You can put that into the Q&A box or the chat, but we would prefer the Q&A box. So today's webinar is titled, Why Aren't My Laxatives Working? A Primer on the Role of the Pelvic Floor in the Development of Chronic Constipation. We're so lucky this evening to have my friend and colleague, Dr. Darren Brenner, here. Dr. Brenner is an Associate Professor of Medicine and Surgery in the Division of Gastroenterology at Northwestern University, and he serves as the Director of the Neurogastro-Motility and Functional Bowel Programs, as well as the Co-Director of the Integrated Bowel Dysfunction Program. He's also the Director of the Mott's Tonelli GI Physiology Laboratory. He's an active Irene D. Pritzker Research Scholar, and he focuses his clinical and research pursuits on a wide range of topics, including IBS, constipation, opioid-related constipation, fecal incontinence, gastroparesis, and scleroderma. He's published more than 100 articles, abstracts, and online materials, and has lectured both nationally and internationally in these areas. He acts as a reviewer and editor for multiple GI peer-reviewed journals and is a current Associate Editor of the American Journal of Gastroenterology. He was a charter board member of the American Gastroenterological Association Academy of GI and liver educators and serves on multiple ACG committees. He's also a fellow of the American Gastroenterological Association. Dr. Brunner has been named to the Helio 200 Top Innovators in GI and Hepatology and the Best Doctors in America lists. So without further ado, here is Dr. Darren Brunner. Thanks, Christine, and thanks all of you for having me. I know it's afternoon or evening, depending on where you live in the country and also depending on where you live, you're either in quarantine or maybe thanking the stars that you can go out and get a little bit of fresh air. I appreciate the introduction. At the end of the day, I'm just the guy that takes care of butts and guts. If you have problems with motility, that's predominantly what I see in my clinical practice. And I'm honored to talk to you all tonight a little bit about pelvic floor and how it relates to constipation. I just want to thank Flemming who's been working with me through AUGS the last month or so to put this together. She has been very nice about letting me modify my slides. Most recently, about an hour and a half to two hours ago, I changed the beginning and the end of my deck because I met, via telemedicine or video medicine, this morning a very nice young lady who unfortunately I think was inappropriately treated and brings home in a case-based scenario exactly what I'm going to try and get across in our discussion this evening. Hopefully this will be informative, rewarding, not put you to sleep if you need a nap after a long day, and I'll be happy to stay on and take any questions you have at the end. Again, I changed the slides a little bit, but I'm going to move on to the case. Again, this is somebody that I met just a few hours ago, 27-year-old young lady with a history of malignant melanoma and Hashimoto's thyroiditis who presented to me for further evaluation of her constipation dating back to college, so just a few years, not back to her childhood or infancy. She had been seen by multiple gastroenterologists. She was noting that she was having bowel movements every two weeks. These were Bristol 1 in texture. She endured sensations of straining, incomplete evacuation, and mechanical obstruction. She had stimulant and osmotic laxatives, probiotics, and enemas, and she told me that historically when she took the enemas, part of the problem was she couldn't get the liquid out, so then she'd present to the emergency room, and they'd give her even bigger enemas, and that wouldn't come out either. She had right here a colonoscopy, but realistically, ever since she presented, a colonoscopy every year since her early 20s, which were all normal, and then radiopaque marker testing that showed evidence of delayed colonic transit. Because of that radiopaque marker test, she underwent a total abdominal colectomy a few months ago with an iliorectal anastomosis, and when I talked to her this morning, she said, I am right back where I was before they took out my colon. Now she tells me unlike last time, she also looks six months pregnant all the time, and what can I do for her with regards to that issue? Obviously not the easiest case, a complicated case, but the history here and the timeline before we even begin to talk about what we should be doing for patients with constipation is completely wrong. I will circle back to this with probably one of my last few slides. The question becomes at the beginning, why do we even care about constipation? The honest answer is because this is a common, common disorder. It's something I know all of you see because we share that space of the pelvic floor. I just get to take care of the posterior portion of it. If you look at the prevalence rates, they're all over the place, and this really comes down to how you ask people. If you use stringent research or clinical criteria, the prevalence rates are always going to be lower than self-reporting, but at the end of the day, it usually averages out to about 14% of individuals having chronic constipation, and over the age of 60, this skyrockets. It's about 33.5%. Overall, the prevalence is about one out of seven individuals, and over the age of 60, one in three. I always think of this in terms of what would this look like if I was in a public place? Christine and I both trained at the University of Michigan, where I know both of us saw games in the Big House that can hold 116,000 people. If this is one in seven, you can imagine how many people in the Big House are sitting there with chronic constipation. We know it occurs more so in women and non-Caucasians. The last two bullet points here are what concern me the most. It's the seventh most commonly diagnosed GI disorder in the United States. Between 2006 and 2014, where we were defining and identifying better targeted therapies for constipation, we still saw the rates of ED visits skyrocket. We had to ask ourselves, if we're getting better at treating this disorder and we understand the underlying pathophysiology of constipation better, why are we not doing a better job caring for these patients? I think there's a lot of ways to answer this question. The first one is to look at the sociodemographic and economic components of chronic constipation. As I mentioned in the previous slide, when we think about the risk factors, it's important to note that the number one risk factor for constipation is age. The baby boomers are getting older and they're hitting these age thresholds, so we're seeing higher rates of constipation. From a clinical perspective, the other one that's concerning that we potentially could do something about is the number of medications a patient takes. People are living longer, they're getting older, and as you get older, you get more comorbidities, and more comorbidities mean more medications. It's important to note that even if your patients aren't taking medications that cause constipation, and there's very few and far between because there's hundreds of them, if you have a patient that's taking six or more medications at any given time, that threshold of six medications significantly increases the odds ratio of developing this disorder. The last, I think, modifiable risk factor in this chart is what I like to call the Uber Eats Fortnite population. I think a lot of us are taking advantage of Uber Eats right now, but we don't at baseline. These are people who sit on their couches, eat a lot of McDonald's and play Fortnite all day and all night. Things we can absolutely modify. Other things that are within our purview to modify, as well as practitioners, is what we use to treat patients. What I'm showing on the left-hand side here are two pie charts that talk about what we're giving our patients to treat constipation. The results are a bit staggering. If you look at the upper pie chart, I want you to focus on the lavender portion of the pie and the green portion. This is stool softeners, pre and probiotics. One third of all patients in these surveys, and this survey was done by a good friend of mine, Lucy Harris, who practices at Mayo Scottsdale. She was able to show that a third of patients were taking one of these probiotics. She was able to show that a third of patients were taking one of these probiotics. She was able to show that a third of patients were taking one of these probiotics. If you remember the patient I started on with the case, she tried probiotics as well. The data is not yet there for probiotics. Stool softeners, they don't move the needle. They don't move the needle. They don't move the needle. They don't move the needle. 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And if it's opioids, we now have new therapeutics that are FDA-approved to specifically target the constipating effects of opioids in the GI tract without reducing the analgesic effects of these medications. Let's start with slow transit constipation, because this is what we recommend starting up front. And you can see what I'm showing you here are not the actual drugs within class, but the actual classes of medications. And there are at least eight classes of medications that you can use to try and treat constipation. So when 50% of my patients say there aren't enough therapeutics out there, but 97% of them are prescribing the over-the-counters, well, I don't think you're getting into the weeds at that point, and you need to. If we think about constipation and we want to simplify it for ourselves or for our patients, here's how I look at constipation overall in terms of a spectrum. There are two different processes. The first process I like to call the bulldozer effect. When you eat, you have to get food from your mouth to your rectum. And that entire process, once the food leaves the upper portion of your esophagus, is based on smooth muscle contraction, which we have no control over. And if somebody's smooth muscle fails, then what we do is we give those patients laxatives. And laxatives are used to treat with a little bit of variation, IBSC and chronic constipation, because they will push the food in the stool through the GI tract. That is what they do. But once the stool gets to the rectum, another completely different process takes over, which I think all of us are comfortable with, which is dyssynergic defecation. And to dumb down what that is, it is opening the door at the bottom of the pelvic floor to let the stool out. So that's why I ask my patients at times, do you feel like there's stool in your bottom and you can feel it there, but there's a door that you just can't get to open up? And that's important because at the end of the day, if you can't get that door to open, that is the rate limiting step for a multitude of reasons. Number one, think of your GI tract like a pipe, okay? Whether you put solid foods into a pipe or liquid foods into a pipe and they imbibe down towards the bottom, if you got a cork at the bottom of the pipe, nothing's coming out and everything backs up from there. So we are nothing more than fancy plumbing. It is the exact same process in our GI tract. So if your problem is in the pelvic floor, laxatives are not gonna stop or cure that problem. That is why when we design the algorithms for constipation, it does not take us long to start looking at the pelvic floor. So this is an algorithm that was designed by Adil Guruchi, he's a colleague of mine from Mayo Rochester. And you can walk through the upper part of the diagnostic evaluation. You have an interview and physical exam, which is what we all do every day. Consider metabolic or structural evaluations, i.e. maybe a TSH and a calcium level. Try fiber over-the-counter laxatives, but if they do not work, the first test we recommend is interrectal manometry and balloon expulsion testing to assess for disemergent defecation. Now, this is an older algorithm, it goes back to 2013. So here is an algorithm that was published in Gastroenterology a month ago. And you can see seven years later with a wealth of new data and new research, we have not changed that algorithm that looks identical. Why is this important? Because again, it's telling us we should be looking at our pelvic floors before we go anywhere else if people have tried about two over-the-counter therapies. Now, I don't wanna be negative or insulting in any way, but I wanted to bring up a couple of situations where the odds position statement on the evaluation of obstructive defecation differentiates from what we recommend from the gastroenterologic societies when we write our guidelines. And again, this is a guideline that came out in 2018, and this is very important because it wholeheartedly relates to the case that I showed you earlier. So statement number one within those guidelines was patients with the following symptoms merit referral and evaluation by colonoscopy. Anyone that has a recent change in bowel habits, excessive straining, sensations of incomplete evacuation, abdominal pain and bloating, rectal bleeding, or weight loss. What the GI position statements would say is this. Colonoscopies are only necessary for patients with alarm symptoms or as required for age-appropriate screening. So when we look at these indications, if you have a patient over the age of 45 or 50, and they've never had colon cancer screening, absolutely, we should be doing colonoscopies. But when we look at these specifically highlighted bullet points, which are in the odds position statement, the only ones that should trigger a referral to GI for a colonoscopy is a recent change in bowel habits, rectal bleeding, or weight loss. The straining, incomplete evacuation, abdominal pain, or bloating does not portend a negative consequence whatsoever. And these patients do not necessarily need colonoscopies. The other more important statement that I wanna focus on is this one. If slow transit constipation is diagnosed, it is critical to evaluate the possible etiologies and to treat this before considering obstructive defecation syndrome. This is exactly what my outside hospital colleagues did with a 27-year-old. And unfortunately, realistically, what this is doing is it's putting the cart in front of the horse. Let's go back to the algorithms again. In 2013, we see anorectal manometry. Look at the pelvic floor because it's the rate limiting step. Where do we start recommending radiopaque marker testing? After the patient has had a normal manometry or fixed their pelvic floor. It is further down the algorithm. So that is not where we should be starting. The evaluation in 2020 looks exactly the same. If the manometry is normal, we actually recommend the newer evidence-based therapeutics. And then if you don't get a response, looking at colonic transit. So again, farther down the algorithm, it not being the rate limiting step. Part of the reason that we recommend that is because of this. We know this is not a bi-directional arrow. 50% to two-thirds of all people who have dyssynergic defecation will develop slow transit constipation. And if we fix the dyssynergia with biofeedback, two-thirds of those people will see their slow transit go away de novo. I.e., what we think is happening is if the stool is getting stuck in the pelvic floor, it sends a negative feedback loop to the ascending colon. We actually store our stool in our ascending colon. And that loop says, I got a bunch of stool at the bottom. I can't get it out. Don't send anything over. So when we fix the bottom, that negative signal goes away and things start to move again. So the pelvic floor dysfunction in more than half of cases will cause slow transit constipation. If you try to target the slow transit, you're going in the wrong direction. And I know I've beat this to death, but this is important because this is the major take-home message. We do not start with the transit issue. We start with the pelvic floor. And even more importantly, remember the beginning of the algorithm. Based on the AGA guidelines, we've already tried to treat slow transit constipation with fibrin over-the-counter therapies, and they have failed. So let's assume our patient has dyssynergic defecation. Let's assume our 27-year-old has dyssynergic defecation. This is what those patients look like. They push and push and push, and the stool doesn't go anywhere. To understand how this happens, we have to understand normal bowel parameters. So as I mentioned, how does the GI tract work with respects to constipation or to normal function? Well, we know that one of the most important components of having normal bowel function is eating. The body is primed, more specifically, the colon is primed to contract most vigorously, what we call CAPCs, or high-amplitude propagative contractions, four times during the day. The first time is in the morning when you wake up, which is why a cup of coffee helps, and then after meals. So if your patients come to you and say, I'm constipated and I'm not eating, they are hurting themselves. Try to get them to eat something, because what happens when they eat is that they activate the gastrocolic reflex. The stomach sends a signal to the colon that says they got stuff on here, and it's on its way down, so whatever's stored on that ascending colon, try to get it over. The stool gets to the rectum. The rectum stretches. That stretch leads to the urge for defecation, and if the person's in the right place at the right time, they've all solved up. If they transmit that pressure appropriately from their abdomen to their pelvic floor, the puberectalis and external anal sphincters will relax, and that is voluntary. As all of you are well aware, those are skeletal muscles, so we control them. The pelvic floor will descend, and the person will have a normal bowel movement. If you perturb any portion of that process, it can lead to dyssynergic defecation. And this is how we define functional defecation disorders, or dyssynergic defecation. These are people who meet criteria for chronic constipation or irritable bowel syndrome with constipation, and when we test their pelvic floors, two out of three studies are abnormal. They either fail the balloon expulsion test, they have abnormal parameters on surface EMG or anorectal manometry, and I'll share what those look like in a few slides, or they have some sort of anatomical or functional complication on barium or MRI defecography. Now, let's look at these tests in a bit more detail. This is the balloon expulsion test, okay? You can do it in one of three ways, depending on how much money you want to spend. On the right side is a specific catheter. This costs about $50 to $70 per balloon. This balloon is asserted into the distal rectum. It is blown up with 50 cc's of water, and the patient is asked to pass it on a commode by themselves. There is debate whether normal balloon expulsion testing is one minute or two minutes, but the vast majority of us in clinical practice and the new guidelines recommend a one minute balloon expulsion time. If you want to spend a little bit less money, you can use this party balloon, or you can use a latex-free condom at Northwestern. We attach latex-free condoms to our catheters. We blow them up with 50 cc's of water. We give the patient three minutes to try and pass the balloon, but we consider that normal if they pass more than one minute. And if you ever see a test on the boards, you think somebody has dyssynergic defecation, what is the one test that you can use to try and define that? The answer is the balloon expulsion test. Anorectal manometry. We have two different catheters that most of us are using. We have both of these at Northwestern. On the left is the one I use most regularly. This is the high-resolution anorectal manometry catheter. On the right, the high-definition catheter. You can see there is a difference in the number of sensors between the catheters. The high-resolution has 12. The high-def has 256. Why do I not like the high-definition? Because it gives me much nicer topographic color maps. I don't like it, number one, because you can see it's rigid. The catheter on the left is a floppy noodle. People tolerate that one much better. The second reason is actually those sensors are too sensitive. We get too many false positive results because of those sensors. So we use the catheter on the left, and this is what it looks like. The catheter goes into the rectum about eight to 10 centimeters. There are pressure sensors in the rectum and across the anal sphincters and the puberectalis with a balloon at the top. During part of the analysis, we ask the patient to push like they're trying to have a ball moment or to try and pass the catheter. And this is what we wanna see. An increase in interrectal pressure, which means that they bear down appropriately. And by the way, we do not ask them to strain. We do not want them to strain. We ask them just to push normally. And if they get that increase in interrectal pressure, we wanna see the anal sphincters relax. What we see most commonly in our pelvic floor dysfunction program is one of four abnormal patterns. What is defined as type one dyssynergic defecation. The patient valsalvas appropriately, but instead of the puberectalis and external anal sphincter relaxing, they go into paradoxical spasm or contraction. Type two, known as inadequate defecatory propulsion. The patient does not breathe or push appropriately, so the pressure is not sensed in the rectum, yet the anal sphincters and or puberectalis paradoxically contract. Type three, an appropriate increase in interrectal pressure, but the anal sphincter puberectalis does not relax. And type four, no increase or not an appropriate increase in interrectal pressures. This should increase to 45 millimeters of mercury. And like type three, we do not get relaxation in the puberectalis or anal sphincters. Now, people ask me, is this academic? To a point, because there's not a lot of clinical data that shows that type one versus type four is gonna respond any differently to biofeedback, but the pelvic floor physical therapists like to know because they do tailor the therapy a bit differently for each of these different subtypes. What we see at Northwestern are our catheters are, like I said earlier, these color topographic maps. I'll walk you through them. Normal pattern, patient balsalvas. These are the interrectal sensors. You see an increase in pressure and relaxation of the puberectalis, which is up here in the anal sphincters. Type one, dyssynergic defecation. After we ask the patient to bear down, you see an increase in interrectal pressure, which is appropriate, but you see paradoxical contraction of the puberectalis and the external anal sphincter. Type two, inadequate defecatory propulsion. We tell the patient to bear down. This is at about 18 to 20 millimeters of mercury. Again, normal is more than 45 millimeters of mercury. And here again, we see a paradoxical contraction of the external anal sphincter in this case. And type three, they get an appropriate increase in interrectal pressures, but no change in the puberectalis or intersphincteric pressures. So not a hard test to use, not a hard test to define. If we look at how we treat dyssynergic defecation, the societies are steadfast. We start with pelvic floor retraining, biofeedback, and or the use of a dietician and or a behavioral psychologist. Now you may ask, why do we use the behavioral psychologists? Because if the patient has a history of abuse, and you just try to treat the pelvic floor dysfunction associated with it, this is anecdotal data coming from Northwestern, although we're doing some clinical trials, our success rate of pelvic floor physical therapy falls in the range of zero to 1%. So in our integrated bowel dysfunction program, we have a behavioral psychologist that sees all these patients as well. So you can think of an evacuation disorder, less of as a, in many cases, as discoordination of the pelvic floor, but as a biopsychosocial abnormality. Looking at the updated guidelines, you'll see exactly the same thing. They recommend, if you have evidence of dyssynergic defecation, pelvic floor biofeedback therapy. So again, no matter what society we look at, the recommendations are kind of steadfast and finite. What are we doing in pelvic floor physical therapy and biofeedback? Well, it depends on the therapist you use, and you do want to vet your pelvic floor physical therapist. Because I have lots of patients who see local therapists, they do eight to 10 sessions, and they call me and they say, Darren, this is not working for me. And I ask them, what is happening? And they're saying, well, I see the therapist for about 45 minutes, and that therapist rubs my belly, and they stick their fingers in my rectum and they rub those as well. That is not going to cure the problem. Data shows that that is not effective. So you want these patients to have biofeedback. If you have a therapist you trust, they're probably doing one of the three maneuvers you see here. On the left is EMG or pro-guided visual biofeedback. The therapist will show the patient how to relax their pelvic floor, how to diaphragmatically breathe, and then on the screen, they'll show them when they're doing it right, and they'll have them practice this over and over and over again until this voluntary process, again, these are skeletal muscles we control, becomes involuntary, so they don't have to think about it anymore, and the pelvic floor relaxes when they push. For people who fail the balloon expulsion test, we actually put catheters into the rectum with a balloon. We blow the balloon up, usually not with water, with air, to about 30 or 50 cc's. We do this with the patient in the left lateral decubitus position or seating, and we ask the patient to try and pass the balloon. If they cannot do that, a good pelvic floor physical therapist will actually sit there next to the commode and hold traction on the catheter outside the anal rectum and help that balloon come out so the muscles start to learn what they're supposed to be doing. The third part of the biofeedback is for people who have a hyper-compliant or hyposensitive rectum. You can blow that balloon up to 250 or 300 cc's, which is a huge balloon, and the patient never gets the urge to go to the bathroom. And this is important because if you don't get the urge, how do you know you need to go? So we can use the balloon or a barostat and do all kinds of sequential inflations and deflations to retrain the rectum to know when to give that person the urge. This is what you wanna see from your pelvic floor physical therapist when they're treating your patients with dyssynergic defecation. I do not mind the massage of the puberectalis or the external anal sphincter. I actually do think that that adds some additive benefit to it, but if that's all they're doing, the likelihood of success is gonna be very, very low. So what's the goal of biofeedback overall? To take that dyssynergic pattern and normalize it. It's as simple as that. How do we know that's what you wanna do? Because we have clinical studies that prove that. This is a nice study that goes back almost about 15 years from Giuseppe Ciarroni's lab in Italy. While it's a small study of 52 patients, it was a well-designed and rigorous study. These were people who failed multiple lapses. They met criteria for chronic constipation, and they had evidence of dyssynergic defecation both by EMG. So he placed EMG stickers along their pelvic floor and he asked them to bear down. They showed paradoxical contraction or spasm of the external anal sphincter, and they could not pass the balloon in one minute. He randomized these patients to one of two different therapies. Biofeedback, only five sessions lasting 30 minutes at a time. So less than two and a half, or actually two and a half hours total of biofeedback, where he gave them PEG-3350, a standard dose, once a day for five weeks. Now, why do I like this trial design? Because PEG-3350, while over-the-counter, is at the top of the food chain. There has been no drug head-to-head that showed that it's more effective than this. So we went after basically the cheapest, safest, most effective drug we have out there. And he wanted to see whether or not patients had symptoms improvements. And if they had improvements, he defined this as biotherapy or major improvements. And even though these patients who got biofeedback only received five 30-minute sessions, he monitored these patients for six and 12 months. And what he was able to show was that the results were the same, both at six months and one year, i.e. there was no decay in response after those five sessions. And the results are staggering. 80% of patients who received those biofeedback treatments noticed a major improvement in their symptoms versus 22% who received the over-the-counter laxative. This is a delta of almost 60% with a number needed to treat less than two. But he also wanted to determine what was going on if these people were getting better. And what he was able to show is that almost 82 to 84% of these patients who received biofeedback therapy corrected the pelvic floor dysfunction, the dyssyneurotic strain pattern, and the inability to pass the balloon. And this occurred in less than 4% of individuals who got the laxative. And that's what we see in clinical practice. If you have a patient with pelvic floor dysfunction and you give them laxatives, no matter what kind, no matter how many, the success rate is about five to 10%. The problem is that many of us practice in areas or non-academic centers where there aren't good pelvic floor physical therapists or your patients can't commute. So I see people from the upper regions of Wisconsin where a visit takes them four hours to get to the university and four hours to get back. They're not going to come for these sessions at Northwestern and in reality these sessions in most practices take longer than about five sessions because there you're working with expert physical therapists. So my friend Satish Rao down in Augusta, Georgia said well, I wonder if we train these individuals when we have them practice at home if home biofeedback can be just as effective as office biofeedback. So this is a study that he published just a few years ago, a very similar trial design. He had 100 individuals, 96% of these were women. He took people who met criteria for disinertification and again, all of them had abnormal spasm of the pelvic floor on interrectal manometry and they failed the bullet explosion test. And they were randomized to see a pelvic floor physical therapist in his practice for one hour over six sessions. So it was every other week for six sessions and the whole base biofeedback group got an initial training session with the pelvic floor physical therapist and they were asked to practice at home with a home biofeedback device 20 minutes twice a day. Now overall the patients who did the home biofeedback practiced a lot more over time than the patients who had the office biofeedback. And the home biofeedback device is very simple to use. It has a little interrectal manometry catheter. The patient inserts that into their rectum and then they work on practicing breathing and relaxing. And if they're doing it right there are either sounds or little lights that light up that show them they're doing it correctly. And what Dr. Rao was able to show was at the end of 12 weeks the overall responder rates were still about 70% whether you were at home or office biofeedback. And again, this correlated very highly with correction of the pelvic floor dysfunction, the disemergent strain pattern, and the ability to pass the balloon. Importantly from a subjective clinical standpoint perspective, what he showed was that both home biofeedback and office biofeedback normalize the average number of complete spontaneous bowel movements that patients were experiencing per week. Going from that less than three spontaneous bowel movements on average in this trial, one, to three to four and a half complete spontaneous bowel movements a week. So you're seeing people that are responding, they're correcting the pelvic floor dysfunction, and they're normalizing their constipation. And again, these are all patients who have failed laxative therapy. The take-home points I could show you at trials all day and all night, here's what you need to know. In randomized clinical trials, 60 to 80% of patients who undergo pelvic floor biofeedback for disemergent defecation have improvement in their symptoms. And pelvic floor biofeedback is compared to placebo, the PEG-3350 we talked about, muscle relaxants, and pelvic floor exercises alone or even sham biofeedback. So we compared it to just pelvic floor exercises, the biofeedback works better. The mechanism of improvement appears to be secondary to correction of the dysinertia. There are some ways to prognosticate who's going to respond. With people performing manual maneuvers and patients having lower baseline bowel satisfaction scores, having a higher pre-test probability of responding to the therapy, and it is the number one therapy or the gold standard recommended by all of our GI societies. If that doesn't work, what else can you do? Well, the problem is that if that doesn't work, what else can you do? Well, the patient has pelvic floor spasm. Maybe some people, I know many of you probably do this if there's tension within your genital cavity, but we'll use muscle relaxants. Interrectal diet can go a long way to helping with pelvic floor physical therapy. But when all else fails, and before we want to consider surgery, there's some data that's come out of Europe looking at the sacral nerve stimulators. And I won't bore you with the details because I know most of you use these for urinary incontinence or fecal incontinence a lot more than I do. We know how these things are placed. The question is, do they work? And some initial data showed that yes, they can. So this is a study in predominantly women who met Rome 3 criteria for chronic constipation, who got medical and or behavioral therapy, and they could receive sacral nerve stimulation. So it wasn't implanted initially like a lot of the fecal incontinence studies. Patients had the leads placed between S2 through S4. And then after two weeks they were asked if they had more than three bowel movements a week, and either a 50% reduction in sensations of straining and or incomplete evacuation. And if they met this endpoint, which 73% of the population did, then they could proceed to chronic stimulation, which means that the battery pack was implanted. We followed these patients as long as we could. The median time was about two years and four months. And what you can see in the table is after the long-term chronic stimulation implantation, significant improvements in bowel movement frequency, an increase by about a factor of three, significant reductions in sensations of straining or incomplete evacuation, and overall treatment success was defined as people had normalization of their bowel parameters, and 63% of people who underwent chronic stimulation met that endpoint, or two-thirds of the patient population. How is it working? Well, I think a lot of times for fecal incontinence, we say we don't know, but in this patient population with constipation, we have some physiologic correlates. Significant reductions in delayed transit. Now, whether this is the chicken or egg, i.e. the transit got better because the pelvic floor got better, we don't know, but maybe it improves colonic motility. We also saw decreased thresholds and perceptions for defecation, i.e. remember that third portion of biofeedback I was talking about, that balloon distension. People were sensing the need to go to the bathroom earlier than they did before. So the improvements in sacral nerve stimulation could be due to transit and or increased rectal sensory perception. And people are still doing clinical trial with this product in Europe. It is not FDA approved for the indication of constipation in the United States as of yet. So let's go back to that really nice 27-year-old to wrap things up. And I say, this is why the pelvic floor matters, what should have been done. So in her visit today, I asked some other questions that had not been asked by any of the other practitioners. And I asked her, have you had any history of abuse? And she told me I had physical abuse when I was younger, I experienced sexual abuse while I was in college, and the constipation developed almost immediately after the sexual trauma. She told me as I worked through the different studies we used to assess the pelvic floor, that it was never evaluated and it was never even mentioned prior to the colectomy. What are we going to be doing for this young lady now? Well, we're going to do a flex sig because she has no idea what portion was taken out. I'm assuming it was a total abdominal colectomy with iliorectal anastomosis. But I'm going to do the flex sig to make sure that this has a residual portion of her rectum, because that's going to play a role in what I'm going to see when I descend the blood in her rectum to see how the nerves in her pelvic floor function, most specifically the pedendal nerve, and whether or not she has a recto-anal inhibitory reflex intact as well from the skeletal arcs. I'm going to refer her to Dr. Sarah Quinton, who's the head of my behavioral psychology program, to address the physical and psychological traumas that are related to the development of pelvic floor dysfunction. She's going to see my dietician. She had before surgery and is now developing after surgery, cytophobia or a fear of eating due to severe bloating and the fact that she looks six months pregnant, and she's now developing concerns about restrictive eating, but she's smart enough to realize that that is a concern. I told her today the reason she looks six months pregnant is one of two things. Number one, she's either fermenting more with the bacteria that's down there, or number two, she's lost that four to five foot reservoir known as the colon, which can descend to about, or sorry, extend to about nine centimeters before you feel discomfort. Now she has a small bowel that's trying to play colon, and it can't do that, and it's going to be distended. She'll follow up my integrated bowel dysfunction clinical. We're going to try and reverse this process, but needless to say, I think we all realize the colectomy probably never should have been done. So I've gone through a lot of details in a very short period of time. I'm going to finish with a few key summary points. Number one, chronic constipation represents a heterogeneous collection of disorders, and determination of the underlying pathogenic mechanism or mechanisms will facilitate improved treatment outcomes. If constipation plus laxatives equals constipation, do not try, try again. Do not remove the colon. Invert this algorithm or this pyramid, and assess the pelvic floor, because at the end of the day, if constipation plus an abnormal interrected manometry and blood expulsion study equals dyssynergic defecation, and in the hands of a good pelvic floor physical therapist, the patient receives biofeedback, you're going to have a healthy and happy patient. At the end of the day, however, you might need multimodal therapy to achieve your best outcomes. With that, I'm going to thank you for my time. What you see here on my right is my Northwestern Integrated Bowel Dysfunction team. Vanna Karolainen is the head of my pelvic floor physical therapy program. Unfortunately, Dr. Bowler, who I love, who was a colleague of ours, has been replaced by Dr. Amy Halverson, who runs our pelvic floor colorectal section. This is Beth Dorpler, my dietician in the pelvic floor, and Dr. Sarah Quinton, who runs our behavioral psychology program. So again, thank you very much for your time and attention. I hope I've left you with a full, a few clinical pearls, and I'll take any questions you may have. Thank you, Dr. Brenner. That was really, really great. We do have some questions. The first one is, can you explain how you fill the condom for the balloon test? Sure. So what we basically do is there's a space between the rectal sensors and the anal sphincter pubertalis sensors on the catheter. It has a groove. We actually use suture, and we just try the cat, we tie the catheter, sorry, the balloon to the catheter. Before the patient comes in, we test the balloon. So we fill it full of air and water to make sure there aren't any leaks, and then we deflate the balloon. The balloon is deflated when it initially goes into the rectum of the patient, and then we blow it up during the test. Now, do we know that the balloon is still working and intact? Yes, because if you remember those color topography maps I showed you with this synergic defecation, as we blow up the balloon and it puts pressure along the walls of the rectum, we see those pressure levels increase. So they go from the light blues, which is nothing, up to the reds, which shows that we're getting increased pressure and distension of the rectal walls. Our next question is, do you think that there is utility of anal rectal manometry or balloon evacuation testing in a patient who has a normal rectal exam, including the ability to voluntary relax their sphincter with bearing down when assessed digitally? It's a great question. Can you still see my slides? Yep. Okay, so I skipped this one. This is why we still recommend doing testing. This is two different clinical studies that assess the benefits of digital rectal examination compared to the balloon expulsion test and anorectal manometry being considered the gold standards. And you can see there's about a false negative rate of about 70 to 80 percent, and a false positive rate that ranges anywhere from about 44 to, in the sense of the anorectal manometry, 13 percent. Overall, when you look at the clinical data that's out there, the balloon expulsion test is the best test, but none of these tests is ultimately that definitive for defining overall pelvic floor dysfunction, which is why we go back to these diagnostic criteria and it says you have to meet two out of three. So yes, we do see people, I know for sure that I've done exams on people and found completely different results on the anorectal manometry balloon expulsion study. And the reason we see some false positives is because, think about it, if I have a young lady, and I actually don't do the test on young women, if I have a young woman who comes in, she has a history of sexual abuse, the last thing that patient wants, especially if they don't tell me, is for me to do a digital rectal exam at our first meeting. And we have patients where there's such PTSD related to that abuse where we will not even start with the anorectal manometry. We'll start with behavioral therapy and sometimes behavioral psychologists will come with the patient to the manometry test when we do it. It is another reason why we never do anorectal manometry balloon expulsion testing in women with male techs or doctors. We always make sure that we have a young female tech in the room to be able to do that study. So while some of us are very good with our fingers, our fingers aren't always right. Remember before we do the finger test, we try latches that fail. And the last thing I ever want to see happen again is what happened to this 27 year old woman. We thought that our finger was the best. It wasn't. We didn't assess pelvic floor dysfunction and the outcome was a colectomy. Another question, Darren, which is near and dear to many urogynecologists, is how do you manage patient expectations after a false positive deficography for a quote-unquote rectocele when our clinical exam doesn't identify a structural defect? Sure, it's hard for us as well because many people will cling to the notion of a rectocele repair is going to equal a cure. And I leave it to your expertise more than ours. On the GI side, we still short our shoulders and say we're not exactly what to do with the deficography results. We don't know what is a good threshold potentially for performing rectocele repairs. And I'll tell you that my personal bias is held with Dee Fetter, who trained me a bit at University of Michigan, and Dr. Bull, who I mentioned, and Dr. Halverson. And we're all sort of in agreement that in many cases, even if it's a rectocele that you see on deficography that doesn't empty all the way, it may not be the cause of the symptoms. So we tell patients, let us put you through the physical therapy and the biofeedback and let's see what that does to your symptoms. It is very similar to what I tell my gastroparetics. They come in and they have horrible gastric emptying studies, but they have minimal symptoms and I say I do not treat diagnostic studies. I treat symptoms. So in the vast majority of the cases, my recommendations to all of you, unless you have a different clinical experience, is if you have a patient where it shows that that rectocele is not preferentially emptying, try pelvic floor physical therapy first. Because again, in many cases, the secondary consequence, our personal bias is the reason that many of these rectoceles formed in the first place is because the stool can't get out of the anus. The internal external sphincters, the pre-rectals are not relaxing. So that stool is looking for a position of least resistance and it forms the rectocele because of it. I hope that answers the question. I think it does. Another question. I think we have time for a couple more. If deficography shows poor muscle coordination or paradoxic contraction, do you need to do anal rectal manometry? We've standardized the anorectal manometry results a little bit better than we have deficography. My personal bias is no. Now, if you look at the algorithms, we always do the anorectal manometries first because we're gastroenterologists. You may glean this data from the deficography because you're looking at the whole pelvic floor. Again, my bias is no. As long as you have a good pelvic floor physical therapist, that therapist will probably detect other problems in the anorectal and work on those. Along the same lines of deficography, do you believe that enterocele seen on deficography can cause tenesmus and a sensation of incomplete bowel emptying? Not unless it's associated with intussusception obstructing the distal rectum and or we see things like solitary rectal ulcer syndrome or sterker ulcers. Then we worry that maybe there's an overlap. But I will tell you, Christina, they're not clinical practice and maybe I'm biased because I don't see these patients. They don't make it to my clinical practice. The patients where we find enteroceles don't usually need some sort of surgical fix and they're not usually part of the problem. But again, that is a biased answer from my patient population. I am not well-versed on people who respond to surgical repairs to enteroceles. There's a question here that I thought is interesting because it's not normally in our wheelhouse. But what is your advice for children with chronic constipation who are too young to understand biofeedback? It's a great question. Usually we want children to have that comprehension. Usually we'll say, you know, late single digits, eight, nine, ten. They probably can perform the maneuvers and those sorts of things. Kids are subjected, I'll use the term subjected, to anorectal manometry at times. And they do try to pass the balloon. But in the vast majority of cases, when people have been referred to me, they have not undergone pelvic floor physical therapy. So unfortunately in children, it is a little bit more of backwards interventions, which is using laxatives to try and improve as much as we can. Gotcha. Last but not least, how do you counsel patients about the importance of behavioral therapy? I know we're fortunate at Northwestern with all your resources and partnering with therapists to avoid the quote, the doctor told me it was all in my head scenario that patients often, you know, that's their gut response when you suggest counseling. Great question. Answer number one, I always tell people when I suggest behavioral therapy, I'm not referring because I think this is all in your head. I obliterate that stereotype immediately. And remember, I see mostly irritable bowel syndrome where the vast majority of patients that I see have been told that. So number one, I try to eliminate the stereotype associated with that. Number two, I make it very clear. I'm not sending them to psychiatry for antidepressants, antihypertensives or, you know, bipolar medication. I'm sending them to a behavioral psychologist within the GI division that does nothing but treat these symptoms all day. Number three, I quote the data. We have data for this and I tell them that there's good data to show that behavioral psychology, especially in the setting of abuse or anxiety can improve these symptoms. And I quote the numbers, like I said during the discussion, zero to one percent versus sixty to eighty percent. In many cases during that visit, if one of my behavioral psychologists is available, I will bring them into the visit to introduce them or in many cases I bring them to that integrated program and that is the first introduction to kind of that biopsychosocial model. And so I try to work through all of that. When all else fails, I talk about the fact that the muscles in the pelvic floor are skeletal muscles. So, you know, people have overlapping headaches. I'm like, you ever have a tension headache? Well, all that is is the tightening of the muscles in your neck. You just tighten different skeletal muscles in your body and they're in the bottom. And lots of people have difficulty treating headaches because, you know, there's a stress component or just won't relax. And there are different ways through behavioral therapy, relaxation techniques, catastrophization learning, and hypnotherapy to improve those symptoms. And a lot of the time using all those specific conversations will get people to buy in. I appreciate that in clinical practice that takes a lot of time. Like you said, Christine, I'm fortunate enough that I work at Northwestern where I have the time to go through those different components of my discussion, but I really, really work that scenario. Unfortunately, there are a lot of times where patients don't buy in. In that case, we do as much as we can with physical therapy and biofeedback and laxatives, but they're not going to get ultimate success. The last point I will make there is the same point I made to the patient this morning. When they are nice enough and honest enough to open up about the abuse history, I ask them if there's a time correlation between that abuse and the onset of their symptoms. I'd say 50% to 60% of the time they are. And another point, do not ask them to extrapolate on the type of abuse. I will usually ask, as a secondary question, do you mind if I was asked if it's physical, sexual, or emotional? For some people that opens the floodgate. The rest of the visit's useless. I don't even get to the pelvic floor. It's just a therapeutic session. And that's great because most of the patients feel better afterwards. But I also tell them that the reason I'm asking is because I can help treat that. If they don't want to open up to me, especially as a male practitioner, I will send them to one of my therapists and they will start to work through that process as well. Well, Darren, I can't thank you enough. And just by what you said right now, I mean, that's the reason why I refer all of my functional GI disorders from my Urogyne All Women's Clinic to you. But on behalf of the AUGS committee, educational committee, I would like to thank Dr. Brenner and everyone for joining us today. Our next webinar is titled, Troubleshooting Sacral Neuromodulation. And that's going to be presented by Dr. Steve Siegel on June 10th. So we hope to see everyone there. And again, this was really a pleasure, Darren. And thanks again. Thanks, Christina. Thanks for having me. I really appreciate the opportunity.

pelvic floor

chronic constipation

assessing pelvic floor function

pelvic floor dysfunction

biofeedback therapy

dysenergetic defecation

muscle relaxants

dietary modifications

multimodal therapy

psychological issues