Experiences in Sacral Neuromodulation for the Treatment of Fecal Incontinence Stephen Cohen, MD, FACS, FASCRS Associate Clinical Professor Emory University School of Medicine

Agenda Prevalence and Impact of Chronic Fecal Incontinence Clinical Outcomes of Sacral Neuromodulation (SNM) Patient Selection and Workup Incorporating InterStim® System into Your Practice Q&A Discussion

Prevalence and Impact of Chronic Fecal Incontinence

OAB 1,2 Asthma 3 Diabetes 4 Osteoporosis 6 Alzheimer’s 7 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, Stewart, W.F et al. Prevalence and Burden of Overactive Bladder in the United States.World Jrnl of Urol 2003:20: Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20(6): Centers for Disease Control and Prevention Website. Accessed October 18, National Diabetes Information Clearinghouse Website. Accessed October 18, Whitehead W.E. et al. Fecal Incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009; 137: National Osteoporosis Foundation Website. Accessed October 18, Alzheimer’s Association Website. Accessed October 18, FI 5 Fecal Incontinence (FI) More Common Than You Might Think

Prevalence of: Urinary Retention, OAB, FI, and Dual Incontinence (DI) Urinary Retention ?? OAB 33 million 1 FI 18 Million 2 DI ~ 9.5 Million 3 1. Stewart, W.F et al. Prevalence and Burden of Overactive Bladder in the United States. World Jrnl of Urol 2003:20: Whitehead W.E. et al. Fecal Incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009; 137: Coyne KS, et al. The prevalence of chronic constipation and faecal incontinence among men and women with symptoms of overactive bladder. BJU Int Jan;107(2):

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 –65% of patients with severe or major FI which had an impact on the quality of life wanted help with their symptoms 2 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): 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):

Fecal Incontinence Quality of Life Scale (FIQOL) Scores Note: Higher scores translate to higher quality of life Rockwood, T. et al. Fecal Incontinence Quality of Life Scale, Dis Colon Rectum, January 2000: 43: 9 – 17. FI Impacts Quality of Life

Clinical Outcomes of Sacral Neuromodulation for the Treatment of Chronic Fecal Incontinence

InterStim Therapy Bowel Control Study 1,2 1. Wexner SD, Coller JA, et al. Ann Surg Mar;251(3): Medtronic-sponsored research. InterStim Therapy Clinical Summary Mean Number of Weekly Incontinent Episodes Per-protocol (completers) (n=106) Baseline Modified Worst Case (MWC) (n=120) Baseline12 Months Clinical Efficacy: Reduction in Weekly Incontinent Episodes, 12 month results

Clinical Efficacy: Complete Continence 12 Month results Percent of Patients with a 100% Reduction in Accidents at 12 Months InterStim Therapy Bowel Control Study 1,2 Per-protocol (n=106 ) MWC (n=120) 41% 36% 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): % Tjandra RCT 3 SNM group (n=53 )

Clinical Efficacy: Quality of Life 1. Wexner SD, Coller JA, Devroede G, et al. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. Mar 2010;251(3): InterStim Therapy Bowel Control Study 1

Adverse Events Pain at implant sites New pain Lead migration Infection Technical or device problems Adverse change in bowel or voiding function Undesirable stimulation or sensations The most common adverse events experienced during clinical studies included: Any of these may require additional surgery or cause return of symptoms. For additional safety information, please refer to the Important Safety Information on the last slide of this presentation.

Patient Selection and Workup for the InterStim System

Patient Selection Sacral neuromodulation can benefit those patients who have: –Chronic fecal incontinence –Patients who may not be able to undergo a more invasive surgical procedure One advantage of InterStim is the ability to evaluate the therapy before implant of the device –Note: tined lead test period is up to 14 days Sacral neuromodulation is not appropriate for patients who: –Have not demonstrated an appropriate response to the evaluation –May require an MRI Now FDA approved for MRI head scans under specific conditions* –Are unable to operate the neuromodulation device (patient programmer) –Are not appropriate candidates for surgery *For InterStim II and specific InterStim I systems. Refer to the labeling prior to an MRI head scan.

Patient Workup When assessing a patient with fecal incontinence for sacral neuromodulation, there are four areas to consider: –Patient history –Bowel diary –Validated QOL questionnaires –Physical exam and diagnostic testing

Initial Assessment and Patient History A detailed history of symptoms, related conditions, and lifestyle factors are essential to understanding a patient's fecal incontinence condition. A detailed history includes: 1 –Current bowel care and management including diet, fluid intake, medications affecting bowel functions –Severity of fecal incontinence –Previous and present lower gastrointestinal function and disorders –Co-morbidity/complication (e.g., urinary incontinence, autonomic dysreflexia, pressure sores, sexual dysfunction) –Previous obstetric and surgical history –Neurological diagnosis and functional level –Patient’s satisfaction, needs, restrictions and quality of life –Environmental factors and barriers and facilitators to independent bowel 1. Abrams P, Andersson KE, et. al. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and Treatment of Urinary Incontinence, Pelvic Organ Prolapse, and Fecal Incontinence. Neurology and Urodynamics. 29: (2010).

Bowel Diary Prior to the first visit, it may be useful to have the patient keep a record of their bowel episodes by using a bowel diary. Self-monitored and includes: –written record of the frequency of bowel episodes –the amount of incontinence experienced, urgency –stool description –whether or not the episode happened while the patient was asleep. Can also be used as a tool to identify a pattern of episodes which may assist in diagnosis.

Validated Quality of Life Questionnaires These tools can help you assess the impact of fecal incontinence on the patient’s lifestyle In addition, determine and document the severity of FI. CCF (Wexner) FI Score FI QOL Score

Physical Exam and Diagnostic Testing Evaluation of defecation function generally requires a combination of two or more assessment techniques. There is no single objective study that can definitively assess all aspects of anorectal function. A variety of anorectal investigations can help to define structural or functional abnormalities of anorectal function. Diagnostic tools include: –Anorectal examination –Anal sonography or endoanal ultrasound –Barium defecography (or proctography) –Pelvic MRI –Anorectal manometry –Colonoscopy –Barium enema

InterStim: Treatment Algorithm for FI Initial Evaluation InterStim System Implant Conservative Treatment Diet Modification Medication Behavioral Therapy Continue as Appropriate InterStim Basic Evaluation InterStim Advanced Evaluation Consider Other Surgical Treatment Failed Conservative Treatment Patient Improvement Positive Negative

Incorporating the InterStim System into Your Practice

Patient Resources Patient information on InterStim System on Medtronic website: – incontinencehttp:// incontinence –Patient Education Materials and Video –Bowel Ambassador Program Patient Therapy Guide/Patient Post-Op Instruction Sheets

Medtronic Reimbursement Resources Medtronic has resources available to assist your practice with coding and reimbursement considerations: Field Based Health Economics Managers (available for coding and reimbursement education, claims reviews, appeal assistance, meetings with facilities, etc.) Coding Sheets (Procedural and Diagnosis) Financial/Coding Models Prior Authorization Guides and Sample Letters of Medical Necessity

The coverage profile for sacral nerve stimulation for fecal incontinence is developing: –Local Medicare Coverage confirmed in all states –Many commercial payers have coverage policies in place Diagnosis code used: – fecal incontinence Same procedural codes (CPTs) used as for urinary control Medtronic provides this information for your convenience only. It is not intended as a recommendation regarding clinical practice. It is always the provider’s responsibility to determine coverage and submit appropriate codes, modifiers, and charges for the services that were rendered. This document provides assistance for FDA approved or cleared indications. Where reimbursement is requested for a use of a product that may be inconsistent with, or not expressly specified in, the FDA cleared or approved labeling (e.g., instructions for use, operator’s manual or package insert) consult with your billing advisors or payers for advice on handling such billing issues. Some payers may have policies that make it inappropriate to submit claims for such items or related service. Contact your Medicare contractor or other payer for interpretation of coverage, coding, and payment policies. Reimbursement Coverage

Summary Ask your patients about fecal incontinence - they won’t come out and tell you Sacral Neuromodulation Ability to test Effective and durable therapy to treat chronic fecal incontinence Strong clinical evidence Reimbursement is generally favorable Medtronic offers comprehensive support

Important Safety Information InterStim ® Therapy for Bowel Control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments. Contraindications: Diathermy. Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator. Precautions/Adverse Events: Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 18; or for patients with progressive, systemic neurological diseases. The system may be affected by or adversely affect cardiac devices, electrocautery, defibrillators, ultrasonic equipment, radiation therapy, MRI, theft detectors/ screening devices. Adverse events include pain at the implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations, including jolting or shock sensations. For full prescribing information, please call Medtronic at and/or consult Medtronic’s website at Product technical manual must be reviewed prior to use for detailed disclosure. USA Rx Only. Rev 0409

Q & A Discussion