An interview with Professor Steven D. Wexner who shares his insights on current trends on treatment of faecal incontinence in the USA.
Professor Steven D. Wexner, Director of the Ellen Leifer Shulman & Steven Shulman Digestive Disease Centre at Cleveland Clinic Florida and Chairman of the Department of Colorectal Surgery, a colorectal surgeon with vast experience, inventor of the Wexner Score1,2 for faecal incontinence and Principal Investigator of the study that secured FDA approval of sacral neuromodulation (SNM) for faecal incontinence in the USA3.
Watch the video or read the transcript below
Zoe Garoufalia (ZG): Dr Wexner thank you very much for agreeing to this interview. Is faecal incontinence a common problem in the USA? What are the commonest causes of faecal incontinence in your practice?
Steven D. Wexner (SDW): Faecal incontinence is much more prevalent than we may realise. Some years back, along with Emily Lucas and Heidi Brown from the Department of Urogynecology at the University of California, San Diego and Mark Siegel, our fellow colorectal surgeon in Los Gatos, California, we did a survey through the Nielsen Group. I think it was sponsored by Renew Medical. And the Nielsen Group is a household survey group in the US that used to look at things like television channels. Now they do everything. And they surveyed almost 7000 women, adult women, and found that 18.8% of women functioning, living normal lives, not talking about nursing home or hospital population, 18.8% had at least one episode of faecal incontinence during the prior year. And despite a high number of those people having fairly significant incontinence as judged by scores, quality of life, less than one third actually sought any medical care for it. And one can hypothesize: Is that because it's an embarrassing topic? Is that because they don't know care is available? Is that because they think care means a stoma? Hard to say, but 18.8% was the incidents we found. And the most common reason, would you ask me in my practice tends to be post epiphysiotomy.
ZG: Thank you Dr Wexner, indeed an underestimated issue. You are the creator of the most cited and internationally used scores for assessing faecal incontinence – the Wexner Score for faecal incontinence. The most impressive part is the fact that after all these years, the same score is used without any modifications. How did you come up with these parameters for the score?
SDW: Well, firstly, I am honoured that after 30 years and this is the 30th year since we published the score that we had used for a few years prior proposing it, to find out that it's been validated in dozens of languages around the world, that it's been shown to have statistically significant correlation with validated quality of life instruments, and that it is the most cited. I personally think so because we tried to make it simple. There are scores that go up to 120. There are scores that require you to sit down in front of a computer and fill out multiple, multiple fields. And I participated in the creation of two others: the faecal incontinence quality of life by the ASCRS (American Society and the Faecal incontinence severity index by ASCRS. And I was in their working group, along with one of your colleagues, Constantinos Mavrantonis, if memory serves correct in those two publications. But they're much more complex. This kind of score is very straightforward. I mean, basically solid- liquid- gas. How often? It's never, it's daily, it's weekly, it's monthly, and then we try to put in some quality of life elements. They are limited, but does it interfere? I mean, do you not do things you’d like to do because of the incontinence? If so, how often, do you have to take any protective action, wear pads or anything like that? So, five very easy to remember categories. All, zero through four. So anywhere from 0 to 20. I think the reason it's so popular around the world is because it is just simple, it's reproducible, it's reliable, and it's been validated, as I say, of numerous languages and validated relative to much more complicated, obviously, quality of life instruments. Simplicity is the key.
ZG: Indeed this makes sense. One of the mainstays of current treatment of faecal incontinence is SNM, although its exact mechanism of action is not yet entirely clear. There have been quite a few therapeutic options over the years (artificial bowel sphincter, SECCA, injectables etc). What techniques should the modern colorectal surgeons have in their armamentarium regarding treatment of faecal incontinence?
SDW: Well, it's interesting. When I was at your stage of my career, our options were pretty much sphincter repair, postanal repair, adynamic muscle transfers like gracilis and gluteus, biofeedback, stoma, medical therapy. Then we went through a phase between perhaps 25 years ago and 5 years ago or 10 years ago, when we had all kinds of things on the market. We had a sling, we had an artificial bowel sphincter, a magnetic anal sphincter. We had the radiofrequency procedure. We had a lot of things that came on the market stimulated or dynamic graciloplasty, which you researched with me compared to adynamic. And it all served a purpose. If the patient had significant muscle loss, a replacement therapy, like an artificial bowel sphincter, like a magnetic anal sphincter, like stimulated graciloplasty, are great options, but they're not options anymore. So now we're back to sphincter repair, postanal repair that nobody really does anymore, dynamic muscle transfers, which we happen to do. What's been added and stayed, the only one that stayed is sacral neuromodulation and this is a very robust therapy, but not in every case. Somebody with complete tissue loss may not benefit from sacral neuromodulation. We have posterior tibial nerve stimulation that's not labelled in the U.S., as far as I know, for faecal incontinence, only for overactive bladder. And we have some injectables. There's one on the market in the U.S. There are a couple others outside of the US. So, I think personally, the surgeon should be versed not only in sphincter repair and sacral neuromodulation, but adynamic muscle transfers whether gluteus or gracilis, I personally prefer the gracilis for multiple reasons.
ZG: Should faecal incontinence be treated by the colorectal surgeon alone? Is there a need for multidisciplinary approach in this condition as well?
SDW: Oh, absolutely. I think in this day and age, whether it's cancer, inflammatory bowel disease, pelvic floor disorders, a multidisciplinary team is absolutely the way to go, in part because the patient all often has problems throughout the pelvis. So you may have anterior compartment problems as well as posterior compartment. And I think patients should be evaluated by your gynecology or female urology. For men, it may be worthwhile to see a urologist. Maybe not for every individual case, but certainly for women, when there's an intussusception, there's often a rectocele. When there is perineal descent, there may be vaginal vault prolapse. So multidisciplinary approach is very important.
ZG: You were the lead principal investigator of the multicenter study that played central role for the FDA approval for SNM in patients suffering from faecal incontinence in the USA. Currently do you use SNM or percutaneous tibial nerve stimulation? Why?
SDW: Well, the PTNS, number one is not, to my knowledge, labelled in the U.S. for faecal incontinence. Only for overactive bladder, urinary incontinence. But number two, my friend Charles Knowles from Queen Mary University, London and Cleveland Clinic London, Department of Surgery, was nice enough to ask me to look at a trial that he and Horrocks, I believe, was the first authors at the time. They did a trial, randomized controlled trial, placebo-controlled trial of PTNS. And really were rather disappointing results and most disappointing in patients with pelvic outlet obstructive symptoms. So the patients who had associated intussuception type symptoms specifically did worse. And based on my in-depth analysis of all of his data, which he made available to me as I reviewed his randomized controlled trial, it was apparent to me that it's not really a panacea. Like a lot of therapies we see when they first come out, they're titled as the best thing since the round wheel and after other people use them and more patients are treated with whatever the therapy is, we find out that it's really not that impressive. And whether that's fibrin glue or anal fistula plug or PTNS. Even if it were available, I'm not sure I'd necessarily do it.
ZG: Do you perform anal physiology tests and endorectal ultrasound before treating patients with SNM? Do the results of these preoperative tests alter you plan for surgery?
SDW: I don't think any tests are really mandatory in this day and age. And the reason I say that is we've done studies, as have other people showing the results of sacral neuromodulation are the same with or without a sphincter defect of up to 120 degrees. They're the same with or without pudental neuropathy. They're the same with or without a prior sphincter repair. So I'm not sure we gain much other than to objectively track the progress of the patient and possibly in the US anyway if an insurance company authorization is required. But I don't think it's really going to alter the decision making at all. I think a good physical exam. Is the way to go. Now, if it's a patient who is reluctant to undergo implantation of a device and until recently, that used to be if somebody needed MRI compatibility, for example, then and you're thinking about, well, could I do a sphincter repair, then it probably is worthwhile to get either an anal ultrasound or an MRI and see if there is a sphincter defect regardless of physical exam. It's probably worthwhile in that scenario.
ZG: And now some pearls of your wisdom: What are the pitfalls that a young colorectal surgeon treating patient with faecal incontinence should be aware of?
SDW: The main pitfall is we don't have a good replacement therapy. We have some augmentation. With sodium hyaluronic, which I think is commercially the U.S. and I don't have any relation with them. I did design the protocol way back then. There are other products in Argentina and Italy, Gatekeeper and Sphinkeeper and others. We don't have them. So, there's augmentation therapy. There are stimulation therapies with either SNM, as we've discussed, or PTNS, there's repair with either a sphincter repair or theoretically a postanal repair. But the only replacement therapies we have really now are either gracilis or gluteus. And gluteus is a tough operation for a lot of people that aren't familiar with the anatomy. And this applies for the gracilis for some people. And we have diversion. So we do need more replacement therapies. I think the other pitfall is to make sure you match not only the faecal incontinence score, but really the patient's quality of life and expectations with the operation. So, somebody who comes in with an of score of 4, I don't think it's generally worthwhile subjecting them to a lot of physiologic studies nor surgery. I mean, that's a patient which should be medically managed and treated with perhaps pelvic floor retraining, biofeedback therapy. And that's part of the beauty of the score. You can just document all scores if it is only 4 or 8. There's a break point at 10 associated with quality of life. So the patient comes in and their score is ten and they're young and active and they want to play sports, you might treat that patient differently than when they come in at 10 and they're in a nursing home. So I think match the patient to the potential risks and benefits of the therapy. And if you're not going to plan a major therapy, then don't bother getting all these physiology studies either.
ZG: Do you foresee any changes in treatment trends of faecal incontinence? What is the future of treating patients with this disabling condition?
SDW: I suspect there's going to be a medical treatment and I've participated in a few trials along the way that had some compounds that didn't work, but topical therapies, even oral therapies to try to enhance the sphincter muscle tone. That's one. Another one might be an even simpler, easier way to do sacral neuromodulation, that doesn't entail going to the operating room potentially. And another one might be figuring out some type of a replacement therapy again now that there's this big void in the market. Pun intended. There's a big void in the marketplace. And I hope somebody steps in with a device that we can implant or a way to, again, stimulate the muscles that we can use for replacement therapy.
ZG: There are some studies reporting better quality of life in patients with faecal incontinence that have been treated with an end stoma. What is the culture regarding stomas in the USA? Is it considered a taboo to have a stoma? Are patients comfortable with type of treatment?
SDW: I don't think that it's taboo, but there's not a lot of patients that come in and say, I really want a stoma. I mean, there are some end stage faecal incontinence and say: Listen, I don't want anything just give me a stoma. But it’s the small minority. Most people want you to do anything you possibly can to avoid a stoma. And part of this is self-perception. Part of it is what other people might perceive if they knew. Certainly, it's not a morbidity free procedure, even if it's laparoscopic or robotic to create a stoma. So, it's an option as is the Malone antegrade that Norman Williams used to do a lot of. And Norman is the person who taught me back in 1996 sacral neuromodulation during the Malone antegrate procedure. But again they're still major surgical procedures. So I think most people would prefer to try other therapies before having a stoma. But to your point, once people do have a stoma in general, they're pretty happy with no longer being incontinent.
ZG: Dr. Wexner once again you made us wiser. Thank you very much for your time and insights.
SDW: Thank you very much for allowing me here today and asking me those insightful questions. Glad there have been of some use.
References:
- Jorge JM, Wexner SD (1993) Etiology and management of faecal incontinence. Dis Colon Rectum 36:77–97
- van Koughnett JA, Boutros M, Wexner SD. Signs and symptoms in coloproctology: data collection and scores. Colon, Rectum and Anus: Anatomic, Physiologic and Diagnostic Bases for Disease Management. Switzerland: Springer, Cham, 2017:127-50.
- Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for faecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-9. doi: 10.1097/SLA.0b013e3181cf8ed0. PMID: 20160636.