Fecal Incontinence: Beyond Conservative Therapy Presentation #1

Transcription

1 Presentation #1 The following is a transcript from a web-based CME-certified multi-media activity. Interactivity applies only when viewing the activity online. This activity is supported by an educational grant from Salix Pharmaceuticals, Inc. Slide 1 Dr. Mellgren: Hello, this is Dr. Anders Mellgren, Director of the Pelvic Floor Center in Minneapolis. Welcome to this educational activity on fecal incontinence This activity comprises two separate presentations. evaluation for CME credit: 1

2 Presentation #1 Slide 2 Dr. Mellgren: The slides, transcript, audio, Practice Aids and other activity features are available for download for easy access anytime, anywhere. To share your thoughts, ask questions or start a conversation with your peers, click the Discussion tab below. After completing the activity, access the post-test and the evaluation form by clicking the red Credit button to the right. This activity is also featured on OpenCME.org for use on a mobile device. Please search the itunes App Store for OpenCME to download the free app. evaluation for CME credit: 2

3 Presentation #1 Slide 3 evaluation for CME credit: 3

4 Presentation #1 Slide 4 Narrator: Due to the embarrassment and social stigma associated with fecal incontinence, presentation is often delayed for several years. In the first segment of this two-part activity, Dr. Anders Mellgren thoroughly examines the burden, etiology, and evaluation of fecal incontinence, providing practical strategies to make a definitive diagnosis. evaluation for CME credit: 4

5 Presentation #1 Slide 5 1. Rao SS; American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004;99: Dr. Mellgren: Fecal incontinence is usually defined as involuntary passage of fecal matter and/or accidental bowel leakage. We try to distinguish between passive and active incontinence. Passive incontinence is when patients involuntarily have an accident, but they don't have any forewarning. Active or urge incontinence is when patients have an accident despite active attempts to retain the bowel contents. Fecal seepage or soiling is leakage of stool following otherwise normal bowel evacuation. Severity of fecal incontinence can range widely. evaluation for CME credit: 5

6 Presentation #1 Slide 6 evaluation for CME credit: 6

7 Presentation #1 Slide 7 IBS: irritable bowel syndrome. 1. Landefeld CS et al. Ann Intern Med. 2008;148: Drossman DA et al. Dig Dis Sci. 1993;38: Brown HW et al. Int J Clin Pract. 2012;66: Dey AN. Adv Data. 1997;(289): Nelson R et al. Dis Colon Rectum. 1998;41: Drossman DA et al. Dig Dis Sci. 1986;31: Dr. Mellgren: There are some data indicating that women in the community have prevalence of fecal incontinence about 6%, but there are other numbers approaching 20%. The prevalence in men is usually said to be between 5[%] and 10%. Patients do not always bring up their fecal incontinence symptoms with the doctor. It also happens that patients do bring it up with their doctors, but they are told that there is not much to do about the symptoms. evaluation for CME credit: 7

8 Presentation #1 Slide 8 1. Bliss DZ, Norton C. Am J Nurs. 2010;110: Dr. Mellgren: Fecal incontinence has a significant impact on quality of life. Patients don't need to have a lot of accidents before they change their way of living in fear of having an accident. One accident a week, or even more infrequent, will impact their lifestyle. evaluation for CME credit: 8

9 Presentation #1 Slide 9 FIQOL: Fecal Incontinence Quality of Life. 1. Rockwood TH et al. Dis Colon Rectum. 2000;43: Alsheik EH et al. Gastroenterol Res Pract. 2012;2012: Dr. Mellgren: Fecal incontinence can be assessed with severity and quality of life instruments. The Fecal Incontinence Quality of Life scale consists of 29 questions in four different categories. FIQOL scores are significantly lower for all four domains when patients have problems with fecal incontinence when they're compared with the normal population. evaluation for CME credit: 9

10 Presentation #1 Slide Xu X et al. Dis Colon Rectum. 2012;55: Rao SS; American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004;99: Dr. Mellgren: Fecal incontinence is associated with significant costs. It has been estimated that the average annual cost is about $4,000 per person, with a direct medical cost averaging about $2,300. Nonmedical costs average $200, and indirect costs averaged about $1,500. Approximately $400 million per year is spent for adult diapers, and between $1.5 to $7 billion per year is spent on care for patients with fecal incontinence, especially in institutionalized elderly patients. evaluation for CME credit: 10

11 Presentation #1 Slide National Digestive Diseases Information Clearinghouse. NIH Publication No December Accessed March 3, Dr. Mellgren: Fecal incontinence can be due to several reasons. One important reason is anal sphincter injury because of previous childbirth or other surgical traumas. Many patients with fecal incontinence also have loose stools or diarrhea, and it is therefore important to identify conditions that can cause this, for instance, irritable bowel syndrome, colitis, lactose or gluten intolerance, etc. Patients with decreased rectal compliance, for instance, after surgery or radiation treatment, are also more prone to have problems with fecal control. evaluation for CME credit: 11

12 Presentation #1 Rectal prolapse is found in a number of patients with fecal incontinence, especially in the elderly population. Many patients with external rectal prolapse have weak anal sphincters. Patients having an internal rectal prolapse or other types of genital prolapse tend to have weaker sphincter tone. In a few patients, constipation can also lead to fecal incontinence. evaluation for CME credit: 12

13 Presentation #1 Slide 12 evaluation for CME credit: 13

14 Presentation #1 Slide Rao SS; American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004;99: Dr. Mellgren: Evaluation of a patient with fecal incontinence involves a comprehensive history together with appropriate clinical examination. Important questions to ask the patient at the interview [include] onset and precipitating events, previous obstetric history, stool consistency, possible intolerance to certain foods, etc. evaluation for CME credit: 14

15 Presentation #1 Slide Rao SS; American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004;99: Dr. Mellgren: When examining patients with fecal incontinence, it's important to see if there's presence of fecal matter on the outside. If there are prolapsed hemorrhoids, or even rectal prolapse at pushing, we usually look at the perineal descent. It can be useful to also examine patients in the sitting position, especially if there is a suspicion of an external rectal prolapse. The anocutaneous reflex can be assessed by gently stroking the perianal skin with a cotton bud in each of the perineal quadrants. Normal response consists of a brisk contraction of the external anal sphincter. evaluation for CME credit: 15

16 Presentation #1 Slide Rao SS; American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004;99: Dr. Mellgren: Anorectal manometry with rectal sensory testing is the preferred method for defining functional weakness of the external and internal anal sphincters and for detecting abnormal rectal sensation. Imaging of the anal canal, usually performed with ultrasound, can be done with either 2D or 3D technique. A fairly simple and widely available test, it provides excellent imaging of the anal sphincters. At defecography, there is a contrast inserted into the rectum. Preferably, there should also be contrast, at least in the vagina. This test will demonstrate the rectal emptying and may diagnose anatomical abnormalities such as internal rectal introsusception, external rectal prolapse, enterocele, or rectocele. MRI defecography, a similar test, provides improved imaging of the pelvic structure during rectal emptying. A disadvantage with this technique is that it has to be performed in the lying position at most institutions. Pudendum nerve terminal latency tests the function of the pudendal nerve and can sometimes be useful in the assessment of patients prior to anal sphincter repair. evaluation for CME credit: 16

17 Presentation #1 Slide 16 Narrator: Fecal incontinence is a common problem that causes patients great anxiety and has a substantial impact on quality of life. As the burden of fecal incontinence is considerable and most patients do not willingly broach the subject or discuss symptoms, the healthcare professional should directly question patients to determine if further testing is necessary. For those who exhibit symptoms, a thorough history and physical examination, as well as specialized testing, will help confirm the diagnosis and guide patient management strategies. evaluation for CME credit: 17

18 Slide 1 Narrator: Though numerous treatments have been developed for fecal incontinence, not one traditional option has been shown to have consistent, long-term effectiveness with low rates of complications, making this disorder extremely difficult to manage. As the therapeutic armamentarium has recently expanded, Dr. Anders Mellgren discusses contemporary and appropriate treatment options for patients with fecal incontinence. evaluation for CME credit: 18

19 Slide 2 1. Rao SS; American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004;99: National Digestive Diseases Information Clearinghouse (NDDIC). Fecal Incontinence. Accessed March 13, Dr. Mellgren: We usually start with nonsurgical methods. One cornerstone in this treatment is dietary modification and firming up patients' stool habits. Avoiding foods and drinks that may cause loose or more frequent stools is important. Some patients benefit from eating smaller, more frequent meals instead of large meals. Increase of fiber in the diet can be helpful. For some patients, this may firm up the stools and make the stools more regular. For other patients, it will increase the amount of stool and fecal incontinence problems. evaluation for CME credit: 19

20 Slide 3 1. Norton C et al. In: Abrams P et al., eds. Incontinence. Paris, France: Health Publications Ltd; 2009: ; Accessed March 4, Dr. Mellgren: We also use some medications to try to firm up the stools. Loperamide or diphenoxylate/atropine are frequently used, especially in patients with a looser stool consistency. Other alternatives include cholestyramine, especially in patients who have had cholecystectomy or have shorter bowel. Amitriptyline is also used for the constipating side effect. Other medications can be aimed at treating patients' concomitant irritable bowel symptoms. evaluation for CME credit: 20

21 Slide 4 1. Rao SS; American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004;99: Borrie MJ, Davidson HA. Can Med Assoc J. 1992;147: Mellgren A et al. Dis Colon Rectum. 1999;42: Dr. Mellgren: Frequently used with other nonsurgical treatment, biofeedback does require a motivated patient and must be customized to address the underlying cause of symptoms. In a review of 35 prospective studies using biofeedback to treat fecal incontinence, it was determined that most of the studies reported positive results. However, sometimes it is more difficult to predict the long-term results of this treatment. evaluation for CME credit: 21

22 Slide 5 evaluation for CME credit: 22

23 Slide 6 1. National Digestive Diseases Information Clearinghouse. Fecal incontinence. NIH Publication No Updated January Accessed March 5, Dr. Mellgren: Traditionally, surgical therapy for fecal incontinence included sphincteroplasty, postanal repair, and colostomy. Sphincteroplasty is repair of a defined anatomic injury in the anal sphincters, usually sustained at childbirth or surgery. Usually this treatment is performed with an overlapping repair. Traditionally, we thought that sphincteroplasty was a very effective treatment for fecal incontinence, with a success rate of 70[%] to 80%. In the last 10 years, these numbers have been downgraded, and [it] has been noted that the effect of sphincteroplasty deteriorates with time. Postanal repair is not performed much any longer. The long-term results are disappointing. Colostomy can be a surgical alternative, but it has poor acceptance among patients. evaluation for CME credit: 23

24 Slide 7 evaluation for CME credit: 24

25 Slide 8 Dr. Mellgren: There are new treatment options. In 2011, there was an injectable approved by the FDA to treat patients with fecal incontinence. The same year, sacral nerve stimulation was approved, and this is an excellent treatment for patients with significant fecal incontinence. Other procedures include radiofrequency treatment of the anal canal and the artificial bowel sphincter. evaluation for CME credit: 25

26 Slide 9 1. Solesta [package insert]. Raleigh, NC: Solesta Pharmaceuticals, Inc.; Stenberg A et al. J Urol. 2003;169: Dr. Mellgren: NASHA/Dx, a stabilized non-animal hyaluronic acid with a dextranomer gel, is administered with four injections into the submucosal layer of the anal canal. This treatment is approved for treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy. evaluation for CME credit: 26

27 Slide Salix Pharmaceuticals, Inc. Accessed March 4, Dr. Mellgren: A quick outpatient procedure, administration takes approximately 10 minutes, and there is no anesthesia required. The needle should be inserted approximately 3 to 5 mm inside the mucosa, and the injection is carried out just above the dentate line. A small bulge is usually seen after the injection, but not always. Patients are able to resume a normal lifestyle and engage in more strenuous physical activities after approximately 1 week. evaluation for CME credit: 27

28 Slide Graf W et al; NASHA Dx Study Group. Lancet. 377(9770): Mellgren A et al. The American Society of Colon & Rectal Surgeons Annual Scientific Meeting 2012 (ASCRS 2012). Abstract S Dodi G et al. Gastroenterol Res Pract. 2010;2010: La Torre F, de la Portilla F. Colorectal Dis Feb 1. [Epub ahead of print]. 5. Danielson J et al. Dis Colon Rectum. 2009;52: Danielson J et al. Tech Coloproctol Dec 7. [Epub ahead of print]. Dr. Mellgren: The largest study on NASHA/Dx was a randomized study that compared a sham arm with patients treated with NASHA/Dx. This study included eight centers in the United States and five centers in Europe, and in total 206 patients. NASHA/Dx had a higher proportion of responders compared with sham, and there was a durability of response after 12 months. There has also been an open-label study and a proof-of-concept study published in the literature. evaluation for CME credit: 28

29 Slide Graf W et al.; NASHA Dx Study Group. Lancet. 2011;377(9770): Mellgren A et al. ASCRS Abstract S46. Dr. Mellgren: After NASHA/Dx treatment, there was an increase of incontinence-free days from approximately 4 days to 8 days. The decrease of fecal incontinence episodes was sustained up to 3 years. evaluation for CME credit: 29

30 Slide 13 CCFIS: Cleveland Clinic Florida Incontinence Score. 1. Graf W et al.; NASHA Dx Study Group. Lancet. 2011;377(9770): Dr. Mellgren: NASHA/Dx demonstrated an improvement in quality of life parameters when compared with sham. Most adverse events after treatment with NASHA/Dx were minor and included rectal bleeding, mild rectal discomfort, loose stools or diarrhea, injection-site pain, mild fever, and rectal discharge. evaluation for CME credit: 30

31 Slide Medtronic, Inc. Accessed Match 7, Dr. Mellgren: Sacral nerve stimulation modulates the sacral nerves. A lead placed in the S3 foramen provides continuous electric stimulation. This treatment is performed in two stages. A temporary or a permanent lead is inserted under sedation and local anesthesia. For patients with good effect of the test stimulation, [a] permanent internal stimulator is implanted after 1 to 2 weeks. Usually, patients need to have at least 50% of decrease in incontinence episodes to undergo the next step of the treatment, and a majority of patients achieve this. evaluation for CME credit: 31

32 Slide 15 FIQOL: Fecal Incontinence Quality of Life Scale; FISI: Fecal Incontinence Severity Index; NR: not reported. 1. Wexner SD et al. Ann Surg. 2010;251: Mellgren A et al. Dis Colon Rectum. 2011;54: Devroede G et al. Female Pelvic Med Reconstr Surg. 2012;18: Hull T et al. Dis Colon Rectum. 2013;56: Dr. Mellgren: In 2010, Wexner and colleagues published a North American multicenter trial evaluating sacral nerve stimulation. One hundred and thirty-three patients underwent test stimulation, and 90% qualified to be implanted with a stimulator. At 12 months, 83% had achieved therapeutic success, and about 40% reported complete continence. At 24 months, the therapeutic success was 85%. Mellgren and colleagues followed up the same population in a paper in At 3 years, 86 patients had a significant decrease of incontinence episodes, and perfect continence was maintained in 40%. Sacral nerve stimulation had a positive impact on quality of life. The most common device- or therapy-related adverse events were usually minor, and included paresthesia, change in the sensation of the stimulation, and about a 10% risk for infection. evaluation for CME credit: 32

33 Half of the infections could be managed with medical therapy. In total, 5% of the patients had the device explanted because of infection. It is noteworthy, however, that these patients can usually be reimplanted at a later day. There is also a more recent publication in 2012 where Dr. Devroede and colleagues studied the same population; they reported similar results. evaluation for CME credit: 33

34 Slide Mederi Therapeutics Inc. Accessed March 7, Dr. Mellgren: Radiofrequency treatment induces collagen denaturation, the tissue contracts, and the muscle tone is possibly improved. It's indicated for the treatment of fecal incontinence patients with incontinence to solid or liquid stools at least once per week. Patients are usually treated with 20 sets of energy delivered to the anal canal with four needle insertions. evaluation for CME credit: 34

35 Slide 17 CCFIS: Cleveland Clinic Florida Incontinence Score. 1. Ruiz D et al. Dis Colon Rectum. 2010;53: Lefebure B et al. Int J Colorectal Dis. 2008;23: Takahashi-Monroy T et al. Dis Colon Rectum. 2008;51: Dr. Mellgren: It has been demonstrated that the Cleveland Clinic Fecal Incontinence Score decreased from approximately 14 to 12 at 1 year, and this effect was sustained at subsequent follow-up after 5 years. There were a few adverse events, mainly ulcerations and minor bleeding reported in a few patients. evaluation for CME credit: 35

36 Slide 18 Dr. Mellgren: Treatment decisions for fecal incontinence should be based on both cause and severity. Most patients start treatment with conservative nonsurgical therapies. They're usually safe; however, success is not guaranteed. Many patients get a bit better, and it is therefore recommended to start with dietary modification, possible use of medications that firm up the stool consistency, and biofeedback. Patients who don't respond favorably to these treatments are usually candidates for further treatment options. NASHA/Dx provides a minimally invasive alternative for treatment of fecal incontinence. It is well tolerated, and it is performed usually in an outpatient setting. Sacral nerve stimulation is also a minimally invasive treatment. It is highly effective in many patients. It does require a trip to an outpatient surgery center, and patients need to limit their physical activity for a few weeks' time. It is provided under sedation and local anesthesia. Other treatment options include radiofrequency treatment. For patients with a recent sphincter injury, we recommend surgical sphincter repair. Patients with end-stage fecal incontinence are counseled regarding artificial bowel sphincter. Patients are also offered colostomy, which however, is not an acceptable option for many patients. evaluation for CME credit: 36

37 Slide 19 Narrator: This activity has been jointly sponsored by Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education. To share your thoughts, ask questions, or start a conversation with your peers, please visit the Discussion Forum by clicking on the "Discussion" tab. evaluation for CME credit: 37