FECAL INCONTINENCE. John H. Winston, III, M.D., M.B.A.

Transcription

1 FECAL INCONTINENCE John H. Winston, III, M.D., M.B.A. Diplomate, American Board of Colon & Rectal Surgery Diplomate, American Board of Surgery

2 Fecal Incontinence (FI) Is Defined as Either the Involuntary Passage or the Inability to Control the Discharge of Stool 1 There are 3 subtypes of FI 1 : Passive incontinence: The involuntary discharge of stool or gas without awareness Urge incontinence: The discharge of fecal matter in spite of active attempts to retain bowel contents Fecal seepage: The leakage of stool following otherwise normal evacuation Inability to defer the urge to pass gas or stool to a socially acceptable time and place Leakage Staining or soilage of under garment Irritation Accidental loss of gas or bowel contents 1. Rao SS; ACOG Practice Parameters Committee. Am J Gastroenterol. 2004;99(8): Jorge JM, Wexner SD. Dis Colon Rectum. 1993;36:

3 The Prevalence of FI Is Increased in the Elderly It is one of the most common reasons for entering a nursing home 1 45% of nursing home residents have FI 2 10% to 15% in the more independent residents up to 70% among the most dependent residents FI affects 16% of non-institutionalized adults aged 70 years and older 1 1. Ditah I, et al. Clin Gastroenterol Hepatol. 2013;Jul 29. doi: /j.cgh [Epub ahead of print]. 2. Landefeld CS, et al. Ann Intern Med. 2008;148(6):

4 Millions of People (US) FI Affects Up to 19 Million People in the United States (US) According to the US National Health and Nutrition Examination Survey (NHANES): 1 Prevalence is 8.4% among non-institutionalized adults in 10 women 2 0 Prevalence Diagnosed Mean age of 49 years 1. Ditah I, et al. Clin Gastroenterol Hepatol. 2013;Jul 29. doi: /j.cgh [Epub ahead of print]. 2. International Foundation for Functional Gastrointestinal Disorders. Managing Incontinence: A survey of those who live with it. Milwaukee, WI,

5 Patient Education Needed Studies suggest that only 15% 45% of FI patients seek treatment 1,2. Consider the following statistics that support the claim that fecal incontinence is a hidden condition: For 84% of patients with FI, the physician was unaware of the patient s disorder 1 54% of patients with FI had not discussed the problem with a professional 2 65% of patients with severe or major FI which had an impact on the quality of life wanted help with their symptoms 3 1. Damon H, Guye O, Seigneurin A, et al. Prevalence of anal incontinence in adults and impact on quality-of-life. Gastroenterol Clin Biol. 2006;30(1): Edwards NI, Jones D. The Prevalence of Faecal Incontinence in Older People Living at Home. Age Ageing. 2001;30(6): Perry S, Shaw C, McGrother C, et al. Prevalence of faecal incontinence in adults aged 40 years or more living in the community. Gut. 2002;50(4):

6 Don t Be Embarrassed Bowel control problems can be upsetting and embarrassing. Don t be ashamed to discuss with your doctor. It is often due to a medical problem. There are treatment options! National Institute of Diabetes and Digestive and Kidney Diseases. Fecal Incontinence, WH AA. Slide 20 of 44. August 2013

7 FI Impacts Quality of Life Fecal Incontinence Quality of Life Scale (FIQOL) Scores Note: Higher scores translate to higher quality of life Medtronic data on file. InterStim Therapy for Bowel Control Prospective Clinical Study. PMA#P

8 UROGENITAL ANATOMY Levator ani Pubrectalis Iliococcygeus Pubococcygeus External sphincter Internal sphincter Urethral support system Levator ani (puborectalis) Arcus tendineus fasciae pelvis Endopelvic fascia Paravaginal fascia ANTERIOR COMPARTMENT POSTERIOR COMPARTMENT

9 UROGENITAL ANATOMY

10 Colonic factors Stool volume Stool consistency Anorectal factors MECHANISMS OF FECAL CONTINENCE Capacity/compliance of rectum Anal seal of vascular cushions Muscular factors Sphincteric/pelvic floor function Intact anal sphincter Neurological factors Rectal sensation Normal mentation Intact innervation/reflexes Problems likely due to several causes Treatment must be directed at multiple causes

11 Fecal Incontinence Has Many Causes 1,2 Traumatic Injury Pelvic Floor Disturbances Inflammatory Conditions Neurological Conditions Diarrhea/ Constipation Obstetric, post-surgical, sexual, accidental Rectal prolapse, descending perineum syndrome, weakening or dropping of pelvic floor due to age Ulcerative colitis, Crohn s disease, infectious colitis, radiation proctitis, ischemic colitis Dementia, stroke injury, multiple sclerosis, diabetes mellitus, mental retardation, polyneuropathy, cauda equina lesions, pudendal neuropathy Irritable bowel syndrome, lactose intolerance, laxative, bile malabsorption, secretory diarrhea, impaction/overflow 1. Bharucha AE. Gastroenterol Hepatol. 2008;4(11): Rao SS; ACOG Practice Parameters Committee. Am J Gastroenterol. 2004;99(8):

12 COMPONENTS OF WORKUP History & physical Labs/stool studies Radiology Anal ultrasound Anal MRI Defecography Barium enema Peritoneography Endoscopy Total colonoscopy Rigid sigmoidoscopy Flexible sigmoidoscopy Physiologic test EMG Needle probe Surface Manometry P.N.T.M.L. testing Peritoneometry

13 ANORECTAL LABORATORY

14 ANAL MANOMETRY: Normal resting & contracture RECTAL BALLOON POSTERIOR RIGHT ANTERIOR LEFT

15 Figure 3. Resting Tone Profile Vector Plot Ant Right Left owell,joan MANOMETRY Resting Tone vs. ULTRASOUND: Birth injury & sphincterotomy 3.0 cm igure 4. Maximum Voluntary Contraction Profile Vector Plot 6.0 cm mmhg Maximum Voluntary Contraction mmhg Right Post Ant Post Left MANOMETRY ULTRASOUND.0 cm 3.0 cm mhg 5.0 cm mmhg PROXIMAL ANUS mmhg 2.0 cm mmhg INTERNAL SPHINCTER.0 cm 2.0 cm mhg 4.0 cm mmhg 1.0 cm mmhg DISTAL ANUS mmhg EXTERNAL SPHINCTER 1.0 cm mmhg

16 Non-surgical Treatments Medicines: Soften stool (laxatives). Help form stool (antidiarrheal medicines). Treat systemic disease. Avoid causative medicines. Physical therapy (PT): Improves the pelvic muscle strength, tone, endurance and coordination. May include biofeedback. National Institute of Diabetes and Digestive and Kidney Diseases. Fecal Incontinence, Satish SCR. Practice Guidelines: Diagnosis and Management of Fecal Incontinence. American Journal of Gastroenterology, 2004.

17 Treatments Medicines Diet / fiber 1 Often helpful. Makes stools firmer. Promote more complete passage of bowel movements. Eat more whole grains, fruits, vegetables, or high fiber cereals. Ask your doctor about fiber supplements. Stool softeners 2 Example: Colace Mechansism: Emulsify fat in GI tract and decrease reabsorption of water Mechanism: Increase water content of stool 1. Rao S. Am J Gastroenterol Aug;99(8): Halverson AL. Clin Colon Rectal Surg Feb;18(1): National Institute of Diabetes and Digestive and Kidney Diseases. Fecal Incontinence, Colace is a registered trademark of Roberts Laboratories Inc., Mead Johnson & Company.

18 ARE THERE OTHER OPTIONS? There are now successful surgical options. There is no need to suffer any longer. Be open with your doctor about symptoms. Ask about seeing a specialist. 18

19 Goals of Surgical Treatment The goal of surgery is to: Improve bowel emptying. Improve bowel control. Improve bowel sensation. Help bowel emptying at appropriate times. Past procedures have had poor results Newer, more successful therapies are here! National Institute of Diabetes and Digestive and Kidney Diseases. Fecal Incontinence, Satish SCR. Practice Guidelines: Diagnosis and Management of Fecal Incontinence. American Journal of Gastroenterology, 2004.

20 Surgical Procedures- Sphincter Repair Traditional procedure Can fix multiple problems at same time Requires general anesthesia High complication rate Wound infection Worsening of incontinence Probably treats only one cause Results poor after 5 years Poor results have lead to search for better treatments 20

21 Surgical Procedures Anal sphincter repair 1 Sacral nerve stimulation 2 First a test phase procedure Surgically implanted device if successful Anal bulking agent injection In office No anesthesia and quick Less frequently performed procedures Antegrade colonic enema Graciloplasty SECCA Artificial sphincter Colostomy or diversion 1. Halverson AL, Hull TL. Dis Colon Rectum : InterStim prescribing information. Medtronic, Inc. Secca is a registered trademark of Mederi Therapeutics Inc.

22 Solesta for the Treatment of Fecal Incontinence 22

23 Solesta Injectable Gel Is the Only FDA-approved Injectable Bulking Agent Solesta is a biocompatible, injectable gel consisting of dextranomer microspheres in stabilized hyaluronic acid Expands the top layer in the upper anal canal to improve bowel control Helps seal off anus Helps sense when stool enters rectum (my opinion) A simple procedure Recently arrived in USA Solesta [package insert]. Raleigh, NC: Salix Pharmaceuticals, Inc.;

24 Administration of Solesta Administered as four small injections through an anoscope Should only be administered by physicians experienced in performing anorectal procedures Special training and certification needed. Non-surgical Outpatient procedure No anesthesia required Quick Solesta [package insert]. Raleigh, NC: Salix Pharmaceuticals, Inc.;

25 Solesta Reduces FI Episodes With Significant Results in as Little as 6 Months 1 Mean Number of FI-free days / 14 days Median Number of FI episode / 14 days Continued improvements were maintained over 36 months 2,a Almost a 2-fold increase (4.4 to 8.1 days) in incontinence-free days Baseline FI-free days FI episodes a P<0.001 for mean and median at each time point. 1. Graf W, et al. Lancet. 2011;377: Solesta [package insert]. Raleigh, NC: Salix Pharmaceuticals, Inc.; Mellgren A, et al. Neurogastroenterol Motil. March

26 Solesta Demonstrated Superior Efficacy Compared to Sham Responder 50 (%) 53.2% of patients in the Solesta group achieved a 50% or greater reduction in the number of incontinence episodes compared to baseline at 6 months 80% 60% P= % 53.2% 20% 30.7% 0% Solesta Sham N=206 Solesta [package insert]. Raleigh, NC: Salix Pharmaceuticals, Inc.;

27 Demonstrated Safety With Solesta Over 24 Months Most Commonly Reported Problems after the Procedure Preferred term % Proctalgia (rectal pain) 13.3 Pyrexia (fever) 9.6 Constipation 4.8 Injection site pain 4.8 The majority of problems were mild to moderate, self-limited and resolved within 1 month of the initial injection La Torre, de la Portilla F. Colorectal Dis. 2013;15:

28 SURGICAL TREATMENT: Sacral Neuromodulation for Bowel Control

29 Sacral Nerve Stimulator Recently approved in USA. Like a pacemaker for your anus. A simple two-stage procedure. Done in operating room. Requires postoperative adjustment. Low risk. Very effective 30

30 InterStim Therapy for Urinary Control and Bowel Control An established therapy that expands treatment options for patients with: urge incontinence, urgency-frequency, non-obstructive urinary retention, chronic fecal incontinence who do not benefit from more conservative treatments. More than 100,000 patients worldwide have received InterStim Therapy

31 Mean Number of Weekly Incontinent Episodes InterStim Therapy for Bowel Control Clinical Efficacy: Reduction in Episodes InterStim Therapy Bowel Control Study Modified Worst Case (MWC) (n=120) 1.9 Per-protocol (completers) (n=106) 1. Wexner SD, Coller JA, et al. Ann Surg Mar;251(3): Medtronic-sponsored research. InterStim Therapy Clinical Summary

32 Percent of Patients with a 100% Reduction in Accidents at 12 Months InterStim Therapy for Bowel Control Clinical Efficacy: Complete Continence InterStim Therapy Bowel Control Study 1,2 36% 41% Tjandra RCT 3 47% MWC (n=120) Per-protocol (n=106) SNS group (n=53) 1. Wexner SD, Coller JA, et al. Ann Surg Mar;251(3): Medtronic-sponsored research : InterStim Therapy - Clinical Summary, Tjandra JJ et al. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. May 2008;51(5):

33 Adverse Events The most common problems after the procedure: Pain at implant sites New pain Lead migration Infection Technical or device problems Adverse change in bowel or voiding function Undesirable stimulation or sensations Any of these may require additional surgery or cause return of symptoms.

34 Test for Potential Success Basic Evaluation A temporary lead is placed during a simple in-office procedure and connected to an external stimulator You and your patient assess therapy effects in as few as 3-7 days If successful, patient may proceed directly to long-term lead and device implant through an outpatient procedure If test is inconclusive or unsuccessful, the advance evaluation via the staged test is recommended

35 Test for Potential Success Advanced Evaluation Utilizes a tined lead that anchors in place Placed in the OR during an outpatient procedure Patient assessed for up to 14 days With successful test results, the lead remains in place and the device & lead extension (if applicable) are implanted Complications can occur with the test procedure, including movement of the wire, technical problems with the device, and some temporary pain.

36 Complete InterStim System 3 1. Small wire is placed near the sacral nerves. 2. Implantable neurostimulator generates mild electrical pulses that are delivered through the lead electrodes Clinician and patient programmers are used to set the parameters of the electrical pulses. 1

37 Evaluating for InterStim: Treatment Algorithm Initial Evaluation for Fecal Incontinence Conservative Treatment Diet Modification & Fiber Medication /Physical Therapy/biofeedback + - InterStim Therapy Test Evaluation nd Test Evaluation Continue as Appropriate InterStim Implant Other Surgical Treatment

38 Support from Others Patients respond differently to treatments work with your doctor to find the best treatments for you. Patient story PFD Alliance. WH AA. Slide 26 of 44. August 2013

39 Take Home Points Fecal incontinence is common People do not talk about it Testing can be done There are treatments Treatments are simple Treatments are successful Talk to your doctor

40 THANKS!