Sacral Nerve Stimulation for Fecal Incontinence

1. Sacral Nerve Stimulation for Fecal Incontinence Jorge A. Lagares-Garcia, MD, FACS, FASCRS Chief, Division Colon and Rectal Surgery Director, Colorectal Robotic Epicenter Roper Hospital Charleston Colorectal Surgery Charleston, SC

2. I hear ya, sistah! I was doing my mile walk and my undewear soiled ! Crackcalacking! I have that problem too, but you know what happens when you get old Try to pick up a 10 lbs bowling ball during our bowling night! That was fun! I had the most terrible accident at the grocery store yesterday!!! I had a blast!

4. Background • Socially crippling disorder • Dependent of complex series of learned and reflex responses • Prevalence • 60-84 y.o. 4.2% • >85 y.o. 16.9% Kok et al.1992 • Geriatric 26% and psychiatric 31% Clarke et al.1979

5. Epidemiology • It is estimated that more than 18 million adults in the United States – 1 in 12 – suffer from fecal incontinence (FI)5 • FI is nearly as prevalent as many other chronic diseases and more prevalent than other illnesses well-known to impact many Americans.1-4,6-7 OAB1,2 Asthma3 Diabetes4 Osteoporosis6 Alzheimer’s7 FI 5 1. Stewart, W.F et al. World Jrnl of Urol2003 2. Serels S. CurrMed Res Opin.2004 3. Centers for Disease Control and Prevention Website. http://www.cdc.gov/asthma/brfss/03/lifetime/tableL1.htm. Accessed October 18, 2010. 4. National Diabetes Information Clearinghouse Website. http://www.diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people. Accessed October 18, 2010. 5. Whitehead W.E. et al. Gastroenterology. 2009 6. National Osteoporosis Foundation Website. http://www.nof.org/node/40. Accessed October 18, 2010. 7. Alzheimer’s Association Website. http://www.alz.org/alzheimers_disease_facts_figures.asp. Accessed October 18, 2010.

6. Note: Higher scores translate to higher quality of life FI Impacts Quality of Life Fecal Incontinence Quality of Life Scale (FIQOL) Scores Medtronic data on file. InterStim Therapy for Bowel Control Prospective Clinical Study. PMA#P080025.

8. Patient Education Needed Studies suggest that only 15%– 45% of FI patients seek treatment1. 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 disorder2 • 54% of patients with FI had not discussed the problem with a professional3 • 64% of patients with severe or major FI which had an impact on the quality of life wanted help with their symptoms4 1. PMA #P080025. Damon H, Guye O, Seigneurin A, et al. Prevalence of anal incontinence in adults and impact on quality-of-life. GastroenterolClin Biol. 2006;30(1):37-43.Bano F, Barrington JW. Prevalence of anorectal dysfunction in women attending health care services. IntUrogynecol J Pelvic Floor Dysfunct. 2007;18(1):57-60. 2. PMA #P080025. Damon 2006. 3. PMA #P080025. Edwards NI, Jones D. The Prevalence of Faecal Incontinence in Older People Living at Home. Age Ageing. 2001;30(6):503-7.  4. PMA #P080025. 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):480-484. 

9. Surgical Trauma Fistulectomy Fistulotomy Hemorrhoidectomy Sphincterotomy Pull through operation Low anastomosis Obstetric (3rd or 4th degree 17%) Accidental Penetration/avulsion injury Social injury Colorectal Diseases Hemorrhoids Rectal Prolapse Inflammatory Bowel Disease Malignant tumors Radiation Congenital Anomaly Spina bifida Myelomeningocele Imperforate anus Hirschprung’s disease Etiology

10. Birth-Related Anal Sphincter Trauma After forceps delivery • 81% defects • 38% symptomatic After vacuum extractor • 21% defects • 12% symptomatic Normal delivery • 36% defects • 4% symptomatic Sultan et al., IJGO 1993

11. Neurologic Disease Cerebral Tumor CVA Dementia Trauma Spinal Peripheral Diabetes Multiple Sclerosis Pudendal nerve injury Miscellaneous Laxative abuse Diarrheal conditions Fecal Impaction Encopresis Etiology

12. Physical Examination

13. External Anal Sphincter Defects • Usually Anterior • Usually at mid anal canal level • May be associated with internal sphincter defect • May be multiple

14. EAS Defects

15. External Anal Sphincter Defects 139o EAS Defect Multiple EAS Defects

16. Medical Management Dietary manipulations • Avoid diarrhea causing stools Caffeine Alcohol Fruit juices Prunes Figs Licorice Spicy foods Beans Broccoli Cauliflower • Stool bulkness and firmness • Fiber supplements (Konsyl®, Metamucil®, Citrucel®) • Addition of constipating foods Cheese Yogurt Boiled rice Pasta Bananas Applesauce

17. Non Surgical Treatment • Medications • Antidiarrheals: kaolin, pectin, Al silicate, bismuth, opium derivatives, diphenoxylate hydrochloride, loperamide • Bile salt binders: cholestyramine, colestipol • Sphicter Agonists: loperamide and phenylephrine • Bowel Regime Management • Indicated in patients with neuro deficits, poor rectal compliance, incomplete rectal evacuation, decreased rectal sensation and overflow incontinence • Low-fiber diet, stool softener and judicious use of antidiarrheals • Schedule defecation

18. Surgical Therapy Overlapping Sphincteroplasty

19. Long Term Results • 10 year results , Cleveland Clinic Ohio Zhutsi et al. DC&R.2009

20. Long Term Results Systematic Review Glasgow and Lowry. DC&R. 2012

21. Sacral Neuromodulation (SNS) • Focuses mild electrical pulses on the nerves that control the pelvic floor muscles, anal sphincters, and colon.1 • Offers control of symptoms through direct modulation of the nerve activity.1* 1. KenefickNJ et al. British Journal of Surgery. 2003

22. Sacral Neuromodulation for Bowel Control An established therapy that expands your treatment options for patients with chronic fecal incontinence who have failed or are not candidates for more conservative treatments.

23. SNS Therapy Benefits • Minimally invasive option that does not preclude use of alternative treatments • Proven clinical safety and efficacy • Trial assessment provides informed choice for patient and doctor prior to implant

24. Neuromodulation Therapies OCD1 Parkinson’s Disease Essential Tremor Dystonia1 Chronic Fecal Incontinence, Overactive Bladder and Urinary Retention Chronic Pain Severe Spasticity Gastroparesis1

25. SNS Long Term Data • N=133 test stimulation • 90% success rate • 120 (110 females) mean age of 60.5 years • Mean duration of fecal incontinence of 7 years received chronic implantation • Mean length of follow-up was 3.1 (range, 0.2– 6.1) years • 83 patients completing 3-year follow-up assessment • 86% of patients (P .0001) reported 50% reduction in FI • Decreased from a mean of 9.4 episodes/week at baseline to 1.7. • Perfect continence was achieved in 40% of subjects. Mellgren A, Wexner SD et al. DC&R. 2011

26. SNS Long Term Data • The most common device- or therapy-related adverse events through the mean 36 months of follow-up • Implant site pain (28%) • paresthesia (15%) • change in the sensation of stimulation (12%) • infection (10%). Mellgren A, Wexner SD et al. DC&R. 2011

27. SNS Long Term Data Mellgren A, Wexner SD et al. DC&R. 2011

28. SNS Long Term Data Mellgren A, Wexner SD et al. DC&R. 2011

29. SNS Long Term Data Mellgren A, Wexner SD et al. DC&R. 2011