Thank you. Hi everyone who's joining, we're going to give it a few more minutes to let more participants, enter and then before we know it, we'll start our awesome webinar for the evening. 601 Central Time 701 Eastern Time so let's give it a couple more minutes. 602 Central Time 603 Eastern Time 604 Central Time 605 Eastern Time Okay, I think we can get started and people will sort of trickle in. Good evening, welcome to the AUG's urogynecology webinar series. I'm Christina Lewicki-Gaup and I'm the moderator for tonight's webinar. Today we have the pleasure to listen to a webinar entitled tis the season for good laxation, how to more effectively treat individuals with chronic constipation. Did you know that was kind of a rhyme Darren? That's amazing. Our speaker today is my friend and colleague Dr. Darren Brenner. He is a professor of medicine and surgery in the division of gastroenterology at Northwestern University, and serves as the director of the neuro gastro motility and interdisciplinary bowel dysfunction programs. He's also an active Irene de Pritzker Foundation and research scholar. And Dr. Brenner focuses on a whole lot of stuff. And long story short, he's my go to man when there are there are patients with pelvic floor disorders who have any kind of a functional bowel disorder he's a clinical, you know, whiz, but also acts as a reviewer and editor of multiple GI peer reviewed journals he's on the board of directors of numerous foundations for gastrointestinal disorders, the Rome Foundation for those of you should all know the Rome criteria for various functional bowel disorders. And what I love the most about this is the following in his free time he's an avid practitioner of shodokan karate which I also do as my three boys do as well. He holds a third degree black belt in this art, and he actually served as the head coach of the US Junior national karate team at the World Maccabiah Games in Israel in 2024 where his daughter was the only American karate athlete to win a gold medal. So without further ado, let's give a warm welcome to Dr. Brenner. If you guys have questions please type them into the q&a box and we'll focus on those at the end of the webinar. Believe I have a tail that just walked in here. Four year old. I'm handing it over to Dr. Darren Brenner. Thanks, Darren. Thanks for seeing and thanks for everybody for having me. I'm honored to give this lecture I appreciate anybody who's got time. This time of year a couple days before the holidays as I scatter around like a chicken with my head cut off trying to get last minute gifts and I want to thank Christina for that really nice introduction basically what she said was as a big nerd, so I needed to learn how to do the karate to protect myself. So tonight we're going to talk a little bit about constipation. I think most of you are familiar with this disorder I know many of you see patients that have overlapping constipation incontinence, whether it be urinary or fecal and my goal is to just try to simplify some of the concepts, show you some of the newer data the tricks of the trade, some things that we've added to our armamentarium over the last couple of years what's still confusing, and then some new toys that are coming down the pipeline early next year. As Christina said if you have questions I actually prefer answering questions and giving lectures so please fire away as we walk through the process. So these are my disclosures. So, I thought the best way to go at this was with a case and I think many of us see these patients and have a better understanding of the type of patient we're seeing compared to a lot of my colleagues in GI practice because you're going to see from this case that what the other young woman really was the wrong approach so this is a 27 year old woman who presented to me with a history of malignant melanoma Hashimoto's thyroiditis for further evaluation of her constipation that went back to college. She'd seen multiple gastro neurologists. She says you she was having a bowel movement every two weeks these were Bristol one so things that look like milk duds with straining sensations of incomplete evacuation and mechanical obstruction. She tried stimulant and osmotic laxatives probiotics and enemas and made a very salient point that when she injected the enema fluid into her rectum. It did not come back out. She had a colonoscopy which report was normal radio pick marker testing that was consistent with delayed transit, and she subsequently underwent total abdominal colectomy with iliorectal anastomosis. Months later she returned she says the symptoms are significantly worse than they were prior to the surgery. Now she has persistent pain, her belly looks like she's six to nine months pregnant at all times. And again, she presents to my clinic and says there is a demon in my belly, please help me. So we'll come back to a little bit later what went wrong in this process, but I always cringe when I hear about these surgical interventions before we look at other potential causes of constipation. And we think about constipation, the most important thing we have to do is define it as Christina alluded to, we use these Rome criteria these Rome criteria have not changed in the last 20 years and I doubt that they're going to change when we release Rome five in 2026. This comes down to how we define this disorder, because how doctors perceive constipation and how patients perceive constipation is completely different, but all are correct. So you can see here I present six criteria, three of which are objective frequency, normal being between three a day and three a week. Being Bristol three to five stools, and the need to perform manual maneuvers, the subjective sensors are highly subjective are straining incomplete evacuation, or a sensation of mechanical obstruction usually I'll ask my patients. Do you feel like you have a lot of stool down in the rectum that you just can't get it out, or do you feel like there's a door down there that just won't open and adequately allow this tool to come out. We have to have two of these criteria to meet the diagnosis. Where do we come up with some of these criteria. When we talk about that frequency of three plus three. It was originally based on old criteria from the United Kingdom that goes back 50 to 60 years ago. Finally, the United States in 2018 some of our friends at Harvard looked at what was considered normal and an average American population. And they looked at more than 4700 individuals, and they asked them, how often do you go to the bathroom and that three plus three metric health so again, normals anywhere between three a day and three a week, your patients do not have to have a ball movement a day, although many of my patients try to force that number out. What's interesting is that when we looked at stool texture, the Bristol three to five stools that we saw on this slide is what's considered normal by men, but women have a broader spectrum of what they consider normal ranging anywhere from Bristol two to Bristol six stools. So that tells us that with with respects to demographics, especially with respects to sex, there can be variations in these patterns, and we have to consider those as such. Now I talked about what went wrong in that case. And when somebody comes in and meets criteria for constipation the next most important thing we have to do is identify the sub type, or more importantly types of constipation that may be playing a role. And in so doing, I really break these down into four major categories, which can overlap as you see in the Venn diagram on the right. The first is secondary causes of constipation. These can usually be gleaned from a history and physical exam. Are you pregnant? What do you all see on a regular basis? Is there a mechanical obstruction? Are you taking medications? The most common ones being opioids or benzodiazepines, but there are more than 100 different medications that have been linked to constipation. Even more importantly, if you see a patient who walks in the door who's on six or more medications at any given time, the absolute number of six significantly increases the odds ratio of developing constipation. Are there neuromyopathic disorders, scleroderma, Parkinson's, MS, ALS, the list goes on. Endocrinopathies, diabetes, hypothyroidism, electrolyte deficiencies, all of these we can glean. And then there are the primary idiopathic causes. Normal transit constipation, which most patients meet criteria for irritable bowel syndrome with constipation. Slow transit constipation, which is what the patient was tested for and defined with. And then the evacuation disorders, most commonly dyssynergic defecation, but there's a new classification system that talks about the other types of pelvic floor dysfunction that can be present causing problems other than pelvic floor muscle spasm. And I'll come back to that later. The reason becomes we take these great histories. We're always told, start with history. And if you can't figure it out from the history, take more history. The exception to that rule may be constipation because when it comes down to history, what the clinical trials have shown us is there are no specific symptoms that are pathognomonic for the different subtypes of constipation I just showed you. Can we talk about symptoms suggesting slow transit? Infrequent bowel movements? No. You can't differentiate pelvic floor dysfunction from slow transit constipation with infrequent bowel movements, nor can you define bloating or a lack of urge to defecate. Yes, people who have hypermolar rectums who are hyposensitive, you have to put more stool in the rectum and distend the rectum before you get the urge to go to the bathroom. If you have a patient with slow transit constipation and things don't move through, the stool doesn't get to the rectum, you don't get the urge. And the Bristol stool form scale doesn't help much at all. There are symptoms I would suggest define evacuation disorders. They're not really here, but the key one I can present or provide you with is the first one on this list. The inability to evacuate soft stools or enemas. Soft stools are usually indicative of normal transit. And if you put an enema into the rectum and you can't pass that fluid, it has nothing to do with the transit through the GI tract because you are not putting the laxative through the mouth. It is right there in the bottom and the pelvic floor and somebody can't get that out. The other telltale sign, which I beg my colleagues to do, and anybody that presents with constipation. Ask about a history of trauma, PTSD, physical, sexual, or emotional abuse. A history of one of these particular disorders has a very high pretest probability for pelvic floor dysfunction in a level that ranges anywhere between 90 to 100%. And again, invariably, I don't see people asking these questions, but it allows us to kind of differentiate a particular disorder and what we want to focus on initially. We talk about our patients and getting these histories. At the end of the day, how accurate is patient recall? This comes from my friend Satish Rao's lab in Augusta. This was presented earlier this year at Digestive Disease Week. And at the end of the day, our ability to recall our symptoms is very, very poor. And we often underestimate or overestimate the symptoms based on a seven-day recall questionnaire as opposed to a prospective stool diary. So if you want to learn anything from your patients and you want to figure out what's going on with their bowel symptoms, a daily stool diary is much better. How do we go about evaluating patients with constipation? Well, this is a really nice algorithm. It was designed by Brian Lacey and Nadeel Bharuch at the Mayo Clinic. And you can see that if a patient comes in with chronic constipation, there aren't a lot of upfront tests that we recommend. We recommend using over-the-counter therapies like dietary fiber or laxatives, specifically osmotic laxatives, to treat these individuals. So the question becomes, are we actually doing what the guidelines recommend? And in the GI world, the answer is definitively yes. This is a very nice study that came out a few years ago that asked practicing gastroenterologists, what do you use first and second line to treat patients who present to your clinic with chronic constipation? And you can see it's almost ubiquitous. The first-line treatments were either over-the-counter fibers or osmotics dominated by PEG-3350, with only 3% of gastroenterologists recommending a prescription agent as a first-line therapy. And I think that's absolutely the most appropriate way to go. I think what's more interesting about this data is what happens after the first-line therapy fails. Because you see a precipitous drop in recommendations for fiber. More than half of gastroenterologists say, I will use fiber first. But for those who don't, they don't come back and say, I'll use fiber second. Whereas for those who use osmotics, you'll see that the numbers are all the same. So what this tells me basically is there are two schools of thought when it comes to treating with over-the-counter agents. The first school of gastroenterologists believe fiber is effective. The second one doesn't. The people that use fiber first line, when it fails, goes to the osmotic over-the-counters. The people that believe in the osmotics then move to prescription medications. Because the second lines, we now see that a third of practicing gastroenterologists are providing prescription medications. So the question becomes, who's right? Should it be fiber? Should it be osmotic laxatives like PEG-3350? Or is either of them adequate? And I would argue that the data would show that first and foremost, the best thing to use in our patients is the osmotic laxative like PEG-3350. So this is data from a systematic review I published in the American Journal of Gastroenterology last year, looking at all the over-the-counter therapies to treat chronic idiopathic constipation. And at the top of the food chain, as it has been, as it will probably always will be, is PEG, which got a strong recommendation based on strong levels of evidence. Interestingly enough, look where psyllium, soluble fiber, falls. It's literally at the bottom of the list. And it's behind other things that we don't like to use all the time. I put in air quotes I don't like to use, like the stimulants SENA and bisacodyl, which are actually very safe and very effective in normal daily doses. Now you can ask me, Derek, I've been using psyllium for years. What gives? Why is it so much further down the list? And here's your answer. Because here are the head-to-head trials comparing PEG to other therapeutics on the market, including psyllium. So we've got that study compared to lactulose or procalipide, which is an FDA approved drug used to treat chronic constipation. Tegastrol was FDA approved for IBSC, but has been taken off the market. And I will tease out this data for you. At the end of the day, when these comparative analysis studies were done, PEG was shown to significantly improve stool frequency, texture, the number of complete spontaneous bowel movements compared to all of them, i.e. in these head-to-head trials, PEG dominates all of these other therapies. Now, what can we say about psyllium, soluble fiber? Well, it's been compared to prunes and mangoes and lactulose, and again, to PEG. And at the end of the day, we see the complete opposite. All of those other therapies dominate psyllium. So you can give somebody a psyllium supplement, or you can tell them to chew on a few slices of mango and the mango actually works better. And that's why the algorithm is constructed the way that it is. A nice new thing on the block, kiwis. Kiwis are full of soluble and insoluble fibers, as well as polyphenols that act as antioxidants. And this was a really nice study that compared the use of kiwis, prunes, and psyllium on constipation symptoms. And at the end of the day, you can see whether it was kiwis, prunes, or psyllium on the left, there were no significant differences with respect to outcomes, which was improvements in the number of complete spontaneous bowel movements over the course of a week. What you can see on the right, however, was a significantly higher level of satisfaction for the use of kiwi, compared to both the psyllium and the prunes. And when we looked at the adverse event profiles, we saw the least frequent numbers of adverse events with taking Kiwi, and most importantly, none of the patients in this trial endorsed experiencing abdominal pain or gas-related symptoms when eating Kiwi. So this has become a first-line agent for me and many of the primary care practitioners that I work with. Now, I've shown you what we do as practitioners in the GI world, what are patients using? And that is on the pie graph on the left. And this kind of hurts because as I've just shown you, the vast majority of patients are not gonna respond to fiber. Yet if you look at fiber, stool softeners, and pre and probiotics, more than 50% of patients are using this as first-line therapies. More importantly, more than a third of these are using the stool softeners and pre and probiotics, and there's no data to suggest these are effective at all. Now, we talked to practicing gastroenterologists as to what we think are the hardest issues with dealing with constipation. You can see what gastroenterologists confirm are their biggest issues. One out of every two and a half gastroenterologists argue there aren't enough treatment options. And I don't buy into that one. There are stimulants, there are osmotics, there are saline laxes, there are magnesium components, there are secreted gogs, there are retained gogs, there are fruits, and the list goes on. So I think there are more than enough therapeutics. The other thing gastroenterologists say, two out of every three, patients do not respond well to the treatments I give them. But then I talk to patients every day. Did you try PEG-3350? Of course I didn't, it didn't work. How long did you take it for? One to two doses. That isn't an effective trial. And I think a lot of times the reasons patients have inadequate responses to the treatments is not because the treatment doesn't work, but we're treating the wrong disorder with the wrong therapeutic. I tell my patients, you've been treated for your high blood pressure with a cholesterol drug, it's never gonna work. So what do I mean by that? Well, we follow the algorithm, we try the over-the-counters, and when they don't work, the question next becomes, what should we be doing? And the answer definitively is anorectal manometry and balloon expulsion testing to assess pelvic floor function. And remember in our nice young woman where we removed her colon, no tests of her pelvic floor function were performed before the colectomy occurred. Now, historically, we used to say you should do the anorectal manometry and pelvic floor testing, or you can do radiopaque marker testing to look for slow transit. And you can see on the newer algorithms that testing for slow transit occurs after we test the pelvic floor, and the question is, why? And here's a couple of answers, because we know that these are not ubiquitous processes, and you can see that I drew a one-way arrow from evacuation disorders to slow transit constipation. It turns out that 50 to 60% of people that have evidence of evacuation or functional defecation disorders will have comorbid slow transit. And if we fix the pelvic floor issue, 70 to 80% of the time, that delay in transit goes away de novo, as does upper GI symptoms like abdominal pain, nausea, vomiting, or reflux. And what we think is happening is if the pelvic floor isn't working, the pelvic floor is sending a negative feedback signal to the more proximal colon and upper GI tract saying, hey, I'm full at the end here, there's nowhere else to put the stool, so slow everything down from above. When we fix the pelvic floor dysfunction, that signal goes away and colonic and upper GI motility normalize. The other reason we know that this is an issue is because if you remember what we just talked about, first-line interventions are over the counters. We've already tried to treat slow transit constipation and we've failed. So when we think about constipation, here's how we should do it. We should simplify it into two separate but not potentially mutually exclusive components. The first is push through the GI tract. I eat food, it has to get down to my rectum and I have to get an urge to go to the bathroom before anything can come out. I call this the bulldozer effect. And if the patient has delayed transit, I have to give said patient something to move things through the GI tract faster and the bulldozers are the laxatives. The second stage is when the stool is down there and the patient gets the urge to go to the bathroom, they try to valsalva and relax their pelvic floor musculature and if the pubertalis and the external anal sphincter relax, they'll get that really nice sausage. But for some patients, the pelvic floor relaxes partially, doesn't relax at all or goes into spasm. And this is just the door that will not open and this is the rate limiting step. I explain to my patients, you have a tube of toothpaste down there and you cannot get the cap off. As much as you'd push the top of the tube, nothing's gonna go anywhere. Or I use another analogy, our GI tracts are a long tube, the rectum is a funnel with a narrowing and we have a cork at the bottom and that cork is in place so that we do not leak all over ourselves all the time. And when it gets time to go to the bathroom, we have to be able to remove the cork. If we can't remove the cork and we pour everything in from above, it's just gonna back up in the system and that's exactly what happens in our GI tracts. So the question becomes, why don't our laxatives work if our patients have pelvic floor dysfunction? And the answer is because the pelvic floor is not made up of smooth muscle, but skeletal muscles, the levator anti-complex, the external anal sphincter, we all know we're dealing with skeletal muscles and you can't fix a skeletal muscle with a laxative. And that's the point I'm trying to make on this slide. I'm a runner, if I had an Achilles tear or an Achilles strain, or I'm a baseball player, if I threw a baseball and I hurt my rotator cuff, there's not an orthopedic surgeon in the world that's gonna say to me, Darren, you've got a muscle tear, I want you to take a laxative and rub it on your rotator cuff or on your Achilles for the next three to four months and I guarantee you things are gonna work better. It's an obnoxious statement, right? But the muscles are the same, so the treatments must be the same. Throwing any sort of laxative at pelvic floor dysfunction is gonna be effective about 5% of the time and most of the time the patients are gonna come in endorsing diarrhea, which is the goal. I always say if you have a small hole to get something through, you will pass liquid through that space, but you will not pass a large mass, i.e. you cannot get a Vienna hot dog through the eye of a needle and thus we must look in a different area. Now, not trying to knock Augs, I love you guys, I depend on you, I need you, I appreciate everything you do, but I bring up this statement because this is concerning. This is the position statement from Augs back in 2018 and this is what was stated and I wanna focus on the right side first. This is the quote. If slow transit constipation is diagnosed, it is critical to evaluate the possible etiologies and to treat this before considering obstructive defecation syndrome. From my standpoint and everything I've shown you to this point, this is putting the cart before the horse. Remember, the pelvic floor is the rate limiting step. This is what was done to our patient and it didn't work. Other comments that were made. Patients with the following symptoms merit referral and evaluation by colonoscopy. Recent change in bowel habits, absolutely. Excessive straining, no. A sensation of incomplete evacuation, no. Abdominal pain and bloating, no. Rectal bleeding, depending on the type of bleeding, maybe unintentional weight loss, yes. So I want you to be aware of this. It should be the opposite. We test for obstructive defecation before we worry about slow transit. I know I beat a dead horse. Sorry to the horse on the bottom of the slide, but I just wanna make this very clear. So if your patient meets criteria for constipation, you want to look into functional defecation disorders if they fail a few evidence-based over-the-counter therapies. And you can see here the Rome criteria to be diagnosed with a functional defecation disorder, you have to satisfy a criteria for chronic constipation. And then you have to have two abnormal tests, an abnormal balloon expulsion test, anorectal manometry or surface electromyography or barium studies. So this is what we do here at Northwestern. This is what most GI facilities will do. This is anorectal manometry. There are three different flavors of catheters. The one on the left is outdated. It's a water-perfused catheter. It's nowhere near as accurate. The one on the right is newer, but it is high definition. It is too sensitive. We pick up abnormalities we should never pick up on this catheter all the time. And you could probably tell this is a very rigid catheter. So if somebody has a sharp angulation on their rectum, right above the anal verge, this is not gonna be comfortable. It's like mama bear, papa bear, baby bear. The one most of us use is right in the middle. This is a high resolution catheter. You can see the black markers at the top of the catheter go into the rectum. They assess rectal sensation. The copper portions go across the internal external anal sphincter and puberectalis muscles and give us a whole bunch of great information. I'll show you in a couple of slides like this one. So this is what it looks like when it's inside the body. We do a whole bunch of different maneuvers. The key one is we ask the patient to bear down like they're trying to have a bald moon. We do not say strain. Straining portends something completely different. We wanna say bear down or valsalva. And if the patient pushes correctly, here's what we'll see. An appropriate increase in interrectal pressure so that abdominal pressure is transmitted into the rectum, relaxation of the pelvic floor, a positive recto-anal pressure gradient, and the patient should be able to pass stool normally. But there are abnormal patterns. Type one disinertification. The patient pushes correctly. The muscles not only don't relax, but they go into further spasm. Type two or inadequate defecatory propulsion. The patient doesn't know how to push and the muscles still go into spasm. Type three. The patient pushes correctly. The muscles do not go into spasm, but they also don't relax. And type four, the patient doesn't push correctly and the muscles don't relax. These are important from our perspective to define disinertification, but there's no real clinical literature out there that says that the patient's gonna respond to therapy better if they have one subtype versus the other. I do think, however, this helps the therapist target the types of things that they wanna do. The most important test is the balloon expulsion test. You can do this in many different ways. You can use party balloons. You can pay $75 for the one-time use device on the right, which we don't use at Northwestern. We use latex-free condoms. We connect these to the end of the catheter. We blow them up with 50 cc's of water. We ask the patient to sit on a toilet and they should be able to pass this balloon in 60 seconds or less. So I don't know what kind of questions you get if you get any of these types of questions on your boards, but if you get a test about pelvic floor and constipation and you can choose one test to do, it's the balloon expulsion test. Now, I referenced earlier that we have newer classification. These are the London classification that were published back in 2020 and the way we think about the pelvic floor. And we break pelvic floor abnormalities related to constipation into four specific categories. In the upper left is disorder of rectoanal inhibitory reflex. This falls along the Hirschsprung spectrum. We distend the rectum. The internal anal sphincter does not relax because the neural innervation to the internal anal sphincter has been lost. Disorders of rectal sensation. For patients with constipation, this is gonna be hyposensitive hypercompliance. People who had constipation for years and years and decades and decades, their rectum becomes boggy and flaccid. So for the average person, it takes this amount of stool. If your rectum is this big to begin with, it's gonna take three, four, five times the normal amount of stool to distend the rectum further to get that urge. And at that point, the stuff that's at the bottom is harder and potentially impacted. Disorders of rectoanal coordination is just what we talked about. The synonyms are dissonance, defecation, pelvic floor dysfunction, abnismus, and the list goes on. And then finally disorders of anal tone and contractility. These are the patients that have very tense muscles that baseline. I tell my patients as a joke, but not really. I'm sorry to tell you that you're just a tight ass and things are blocked. But I will also say that anecdotally, historically, I have found that people that have really tight baseline sphincters have a history of some sort of abuse or trauma. And I'll delve into that a little bit further as well. At the end of the day, how do we treat these disorders? Pelvic floor physical therapy and biofeedback. I'm showing you the guidelines from the ACG and the AGA. We never agree. This is the one place where we actually agree. And what are you gonna do is gonna be dependent on what the underlying problem is. So if you had one of those four atypical dyssynergic patterns I showed you earlier, hopefully the therapist is gonna do catheter EMG associated biofeedback, which you see under block one. The EMG stickers go around the anal verge or the catheter is placed. The patient is taught how to breathe and how to push. They can see on the computer screen what they're doing wrong. They can correct this process and make it an involuntary process. Again, in a lot of labs, we don't like to do this laying on your back because you don't poop on your back. We will do this test with you sitting on the commode. For those patients who can't pass the 50 cc water filled balloon in less than a minute, we'll blow up the balloon to lower volume. We'll start with 10, 20, 25, 30, 35 and have you work on relaxing the muscles to pass the balloon. The most dedicated physical therapists will have their patients sitting on the commodes actually put external traction on the catheter with the balloon so the muscles can feel like what they need to do to get the balloon out. And in panel three, those who have rectal hyposensitivity, we use those balloons or baris threats and we blow them up and down to various volumes and levels of distention. And that can retrain the brain to know what a normal volume of distention is for the rectum to signal the urge to go to the bathroom. Does this stuff work? Well, the goal at the end of the day is to take this spasm and get it to relax. How good is it? The best study comes from my friend Giuseppe Ciarroni's lab in Italy. This is a study where we randomized patients who had constipation and evidence of pelvic floor dysfunction. So they had an abnormal anorectal manometry and balloon expulsion testing. And he said, let me either give you biofeedback, it was six sessions every other week for three months, or you can take the over the counter winner of all things PEG 3350. And he asked, how are you doing at the end of six and 12 months? And the numbers are astonishing. 80% of individuals who did the biofeedback said that they had major improvements compared to 22% of placebo. This is a delta of about 58% and a number needed to treat of less than two. And he showed a significant physiologic correlate because what the improvement correlated to was normalization of the pelvic floor spasm and the ability to get out the balloon. Now there are numerous other trials that look at this, but I wanna give you the take home simple messages. In randomized control trials and people with pelvic floor dysfunction who undergo biofeedback, 60 to 80% will experience significant improvements. Now, there's a caveat here. These trials were all done at centers of excellence with superb pelvic floor physical therapists. So if you're working with physical therapists, whether they're in your division or in the community, you wanna make sure you have that good team set up to be able to do this. Because a lot of times my patients come back after a few sessions and they say, I'm no better. And I say, what has the therapist done? Rubbed my belly, rubbed my rectum and taught me Kegel exercises. And then I cringe and I shrug and they say, what's wrong? And I say, I did a test on you that shows that your muscles when you try to push go into spasm and they don't relax. And the therapist is telling you to spasm even more. I'm like, that's having a door and adding three double bolts and an automatic lock that you can turn on and off with your phone. Completely counterintuitive and wrong. So you wanna make sure you have the right therapists. In clinical trials, biofeedback has been shown to be better than oral placebos, Miralax, Diazepam, which is a calcium channel blocker, muscle relaxant and pelvic floor exercises alone. As I said, the physiologic correlate is correction of the pelvic floor dysfunction. And this is something that has been recommended by every major society for treating dyssynergic defecation and the other new classifications that I showed you based on London Consensus. Other things that we can tell our patients in clinic very easily, stool positioning. You don't necessarily have to have a squatty potty. You don't have to pay $30 for that. If you have an old stepstool for your kids or a phone book, as long as the legs are spread, that's good. You want your patients leaning forward. The knees should be higher than the hips and the elbows can be on the knees. That is the correct posture for defecation. Does that posture help? Well, here's a study that's being published, I think this month or next in clinical gastroenterology and hepatology. This is a study that took a whole bunch of people who came in for anorectal manometry, balloon expulsion testing. And one out of every six individuals could not pass that balloon in the first two minutes. Put them on a squatty potty, they were all able to pass the balloon within a minute. They normalized just by putting on the squatty potty. Were there ways to prognosticate who was going to respond? Yes. On their anorectal manometry, if they were able to relax their sphincter complex, they were significantly more likely to respond to the squatty potty than if their sphincter complex did not relax or go into spasm. If you want to do time voiding first thing in the morning or after meals, that's when the colon most vigorously contracts to help go to the bathroom. And your patient should not spend a long amount of time on the toilet. It should be no more than five to 10 minutes when they do it. So we've gone through these. Let's say that we do anorectal manometry, balloon expulsion testing, and everything looks fine. Then the next step in the algorithm is to go to assessments for slow transit constipation. And the best way to do that is with radiopaque marker testing. The simplest way to do that is with SITS marks. There's a capsule that comes, it has 24 to 25 markers in it. Your patient swallows it, the markers are released, you get an x-ray 120 hours later, and you'll see one of three particular patterns. The one on the left is normal. There's less than or equal to five markers in the colon. The second one is consistent with but not pathognomonic for slow transit constipation. The markers are everywhere. And if you get an x-ray and everything's sitting in the pelvic floor, again, consistent with but not specifically pathognomonic for functional defecation disorders, but a very easy tool that anybody can use to look for slow transit. And if you have slow transit and you failed the over the counters, then there are some very good therapeutics that you can try by prescription. And these are the secretagogues. You're probably familiar with some of these, lupiprostone, lenacletide, plecanetide, and the prokinetics like prukalipride. All evidence-based, all FDA approved for the treatment of chronic constipation. Which one do you choose? I don't know. And I don't know that the guidelines help. These are old guidelines. These will be updated first quarter of next year. But you can see I've listed all of these and with exceptions of plecanetide, and this drug was approved after these guidelines, but I can tell you if you re-rank these, all of these get strong recommendations based on moderate to high levels of evidence, and there are no head-to-head trials to compare them. So one way that I work on this is with what I like to call the four Cs, cost and compliance. We all know in this day and age, sometimes the only thing we can prescribe is what the insurance company will give us. What the likelihood of compliance is on the therapeutic and how comfortable you are with prescribing it and the patient is with taking it. That's where we usually start. The problem is this, since the experts can't help design an algorithm, do our patients give us any information? And the answer is yes. So this again is a nice study that was just presented this year, had almost 25,000 people that they assessed, 2,000 met criteria for chronic constipation. And at that time, about a third were taking a prescription laxative plus or minus an over-the-counter, 45% was taking an over-the-counter only, and a quarter weren't taking anything. And when we ask these patients, what drives medication use? Interestingly enough, they said it was abdominal symptoms like abdominal pain or discomfort. And that's important because there are no clinical trials that show that over-the-counter laxatives can improve abdominal symptoms. In many cases, the over-the-counters make them worse. When we asked what was associated with prescription use, patients told us basically, again, the ability to control all of their symptoms. And for those taking over-the-counter laxatives, more than half endorsed that they were working well, but they weren't also aware of the fact that prescription meds could be effective. So about 50% of people not doing well and didn't know that they could take the prescription therapies. Now, why is this important? Because I just mentioned that abdominal symptoms are important and you can see here the symptoms that are most experienced by patients with both IBS and chronic constipation. And across the spectrum, you can see that while pain and bloating occur at a much higher prevalence compared to chronic constipation, the percentage of individuals experiencing constipation is not insignificant or infinitesimal. It's almost half of the patients. This is my way of saying when a patient presents to you, if you treat their constipation, ask about the abdominal symptoms because that may drive you to a prescription laxative a little bit more quickly. So then the question becomes, well, should we be differentiating constipation or slow transit constipation from irritable bowel syndrome with constipation? And my argument is no, I do not feel that these are two separate entities. They are two similar disorders along a spectrum with the severity of the pain being a mediator. We define patients IVSC more times than not when the pain is more severe, but that does not mean that people with constipation can't have pain. And when we use artificial intelligence, the study I'm showing you on the right, and we ask computers to take symptoms and differentiate between chronic constipation and irritable bowel syndrome with constipation, the computer can't. The only way that the computer can differentiate between these two disorders is to tell the computer that irritable bowel syndrome is defined by pain, and then it will differentiate the two. So even AI shows us that without building in these inconsistencies or these specificities, without giving guardrails, there's no way to differentiate between the two. So what can I tell you when it comes to treating patients with constipation if they have abdominal symptoms? Across the board, you will get improvements in bowel symptoms, but you have to look to fiber or the prescription medications before you'll get improvements in abdominal symptoms. So keep that in mind when you're interviewing these patients, thinking about what treatments you want to use. What's coming on the pipeline? This is not going to be available in most places. There are about five or six centers that will roll this out in the United States on January 15th. This is a vibrating capsule. It was approved by the FDA. It modifies circadian rhythms, and in large clinical trials, patients were shown to have significantly higher numbers of complete spontaneous bowel movements compared to placebo, swallowing five capsules a week. It was one capsule, five out of seven days a week. And this is something that, when we look at the side effect profile, is very good for our patients. No real significant side effects compared to placebo. The most common side effect endorsed is that patients noticed that maybe they felt a little bit of vibrating, but none of the patients in the trial actually stopped using it because of that vibration. It's going to be a capsule about the size of a Robitussin. It comes with an activating pod. You stick the capsule in the pod. It takes about two seconds to activate. You take it before bed. You swallow the capsule. And again, significant increases in frequency of complete spontaneous bowel movements, more to come from this process. So, we talked about constipation diagnostics. The question is, are we doing this correctly as practitioners? When it comes to prescribing medications from a gastroenterologist perspective, we are doing it right. Fiber over-the-counter osmotic should be the right thing. Patients are using probiotics and stool softeners. They should not be doing that. What about anorectal manometry? What percentage of patients who come in with constipation are getting anorectal manometry because it should be the first test? 3.5%. Rate-of-pick marker testing? 2.8%. Shocking, less than 10% are getting the recommended diagnostics. And I say shocking because this algorithm has not changed with exception of the placement of the tests over the last 20 years. What are people getting? 85% of patients are getting colonoscopy. There is nowhere on this algorithm where you will find the word colonoscopy. Colonoscopy should be done if there are alarm signs or symptoms or the patients over the age of 45 for age-appropriate screening. 20% get a barium enema. 15% get a flex sig. There's the 15% we were missing with the colonoscopy and 4.5% get wireless motility testing or a smart pill. We are doing this the wrong way in gastroenterology. In terms of updated treatment algorithms, here's what I would recommend. Fiber is fine. Food-based fibers, kiwis, prunes, mangoes, absolutely are over-the-counter osmotics like PEG-3350 or magnesium-containing therapies. Exercise should never be rejected. If your patient comes in and says, should I exercise for anything GI-related? As long as they don't have an orthopedic surgeon or cardiologist that says no, absolutely. Fluid intake, not so much. My patients turn themselves into what they like to call bloated whales. They drink more water than they ever should. There is not a single shred of evidence that says or shows that consuming more water improves constipation. I tell my patients drink to satiety. If the over-the-counter medications fail, then you can go, if you look at the CIC side, to the secretagogues or the prokinetics that we talked about. Notice that there are two arrows if the over-the-counters fail. One is to the prescription medications, but also to rule out pelvic floor dysfunction. What happens after that, quite honestly, refer to me. I will take it from there. You can refer to me anytime you want, but that's where I think, bow out and let us deal with it at that point. So let's go back to that patient. Patient comes to my office. I know hindsight is 20-20, but I asked some other questions. And she says, yes, she has a history of physical and sexual abuse and the constipation developed almost immediately after the sexual trauma occurs. She tells me after I defined the studies that she never underwent a pelvic floor evaluation. I performed a flexible sigmoidoscopy and there was a healthy appearing anastomosis just to make sure there wasn't a post-operative mechanical obstruction. I performed her inter-rectal manometry. Her sphincters were as tight as they can be. She had evidence of type one dis-synergistic defecation, which means the muscles went even further in the spasm. She couldn't pass the balloon and she had no sensation in her rectum. This is where multidisciplinary care is important. I refer to my behavioral psychology program for trauma care and to my pelvic floor physical therapist. This is very important. If your patient presents with trauma and pelvic floor dysfunction, and you try to treat the pelvic floor dysfunction without dealing with the trauma, 90 plus percent of the time that pelvic floor will not improve. I also sent her to my dietician to talk about things like kiwis, mangoes, to deal with some of the bloating symptoms that she was experiencing. She has now since followed up in our clinic. There is some moderate improvement, but she is still suffering from these symptoms. So this is a young lady where pelvic floor testing should have been done initially. We probably never would have taken her to surgery and she wouldn't be where she is today. Because as I like to say, if you ignore the pelvic floor and you just look at transit and you undergo or you perform surgeries, you're going to release the demons that are there. So at the end, in summary, chronic constipation is a heterogeneous collection of disorders for many patients is going to be more than one. Thus defining the underlying conditions is key to improving treatment outcomes. If you have three problems and you have three different treatments, you have to engage all three. If you see these patients and you're giving them laxative after laxative after laxative and they still have constipation, don't give them more laxatives. Invert the pyramid, check their pelvic floor, send them for biofeedback. And as Olaf likes to say, make them happy snowmen. At the end of the day, like I've mentioned multiple times, it might be multimodal therapy. And if you do the colectomy without an assessment of the pelvic floor, remember the demons are just waiting to come out and pounce. So with that, I'm going to say thank you very much with your attention and I'll take any questions you have at this point. Thanks so much, Darren. Excuse me. That was awesome. It's always so good to see like what's down the pike. I'm fascinated by that vibrating capsule. Would you know what centers are going to have that? Yeah. So our stake is one of them. So if you have patients who are interested, refer. We are going to be doing it. Michigan will be doing it. Augusta will be doing it. I believe that the UCLA systems are involved in the Harvard programs. Awesome. I have one question here and that is, you know, how it's, it's difficult for us as urogynecologists sometimes to explain to patients that their quote unquote rectocele is not causing their constipation. Instead, the constipation is likely what caused that laxity to happen because they had dysinertion. They were pushing against that closed door. How do we get like more GI folks to, to think like you know, you know, to think like you and understand how important the pelvic floor is in creating the problem and that fixing the anatomy isn't always the answer. Yeah. You know, it's just a matter of, I think, education on the gastrointestinal side. We don't go to a meeting where we talk about pelvic floor and talk about the chicken or egg phenomenon, but mentioned the excellent trials that you and other people have done showing that repairing these rectoceles in many cases, not only don't solve the problem, but can potentially make things worse. And so we try to avoid that. I always tell patients surgery is the last resort. I scan with adhesions, adhesive disease, those sorts of things. But I also talk about, you know, sometimes I hate to go back to it. I don't call it this because this would make me a huge nerd, but you know, Bernoulli's principle pressures, right? I talk about stool, still having two roads. Okay. And so think of stool like your car. And in Chicago, we have the expressway, right? You have two ways to get downtown. You got the regular lanes and the express lanes and the express lanes are open and they're not bad. Which lane you're going to take to get downtown, right? It's the path of least resistance. It's the express lane. Well, in your GI tract, in your pelvic floor, the muscles don't open and the muscles don't work. You're pushing against the closed valve. Those stools are banging into the door and they're saying, let me out, give me another pathway. And what happens is the rectocele forms. Now the stool will see less pressure there. So they invariably go that direction, but unfortunately there's no door there. There's no way to get out of it. So I tell people it's the fact that the door won't open leading that pressure to form these rectoceles and the stools will go that direction when you test that way. But at the end of the day, if you can get the door open at the bottom, and you can do that with a few sessions of going to see a therapist and physical therapy, as opposed to a surgery, at the end, you're probably going to be, you know, much better off. Um, next question is patients frequently complain of bloating or gas with fiber initiation. Do you have a recommendation on how to initiate fiber and ensure compliance in the long-term? Yeah. Start low and go slow. I start people at a tablespoon a day. I stay away from insoluble, highly fermentable fibers. Dietary fiber is not good. Bran is insoluble and highly fermentable. You want to go in most cases with either the foods I mentioned, more so Kiwi than anything else or soluble viscous fibers, which can gel, which are minimally fermentable, which is psyllium, which we find in Metamucil or in console. Now I will say this. I do tell my patients up front, if you have bloating and distention at baseline, be very, very careful with this. I can never say never that the fiber won't make your symptoms worse, but if it does stop it and move on, I will be honest with all of you. I talked about the two camps, the fiber camp and the PEG camp. I am wholeheartedly the PEG camp. It doesn't mean I won't use fiber, but if I have two options, I will use Miralax as my first therapeutic every time, knowing full well that unfortunately the Achilles heel of Miralax is gas, bloating and distention too. And in these cases where I can't use those, then I will move on to the Secretagox, things like the Linzessas and the Trulances, because it's the complete opposite. In those cases, every clinical study has shown that these drugs can actually improve the abdominal symptoms and not worsen them. Okay. How about your thoughts on Vaginal Valium for dyssynergia? I think it's great. You know, I usually, I'll defer to my physical therapist. I'll ask the patient to ask the therapist, do you think this is effective? For some of my patients with really tight sphincters or anal trauma, as you know, they won't even let the therapist engage internally for X number of sessions. And I've actually had patients who bring their behavioral psychologist with them to initiate that therapy. I think in that case, if they're comfortable with Intravaginal Valium, it will probably work as well. I'd love to see a head-to-head study of these two, but I don't think we'll ever recruit enough patients. The other one I also use is Baclofen, and I think it's fine to use that interrectly or intravaginally. How about Botox for the really tight sphincters? Don't love it. Hasn't been shown to be really effective as induced fecal incontinence. After a few sessions, my colleagues who do my endoanal ultrasounds have identified scarring. I think it's effective if you try it once, maybe twice, under the auspices of doing pelvic floor. Give chemical relaxation while you try to rework the muscles of the pelvic floor. I don't see it as a long-term solution. So it's like a means to an end. I will tell you that I prefer that you try the enemas, or sorry, the suppositories, the Valium or the Baclofen before Botox. Okay. Awesome. Well, Darren, thank you so much. My pleasure. On behalf of the Augs Education Committee, we want to thank you for joining us today. For the audience, if you have any other questions, please feel free to email me. I can get that on to Dr. Brenner. And be sure to register for our upcoming webinar, which is on January 18th, Simulation and FPMRS Education by a Team of Faculty from Emory. Thanks again, and happy holidays. Thanks, Darren. As usual, you've closed out the year in a pleasure way. I always get to, I always get to bring up the rear. It doesn't matter where it's held. I have you every time. Happy holidays, everyone. Thank you. Good night. Good night, everyone.

chronic constipation

pelvic floor dysfunction

Dr. Darren Brenner

over-the-counter therapies

anorectal manometry

biofeedback therapy

dietary changes

vibrating capsule

multidisciplinary approach