1. This presentation has been created for colorectal surgeons who implant InterStim to discuss the therapy with referring clinician groups

2. Welcome
<Insert name(s) of colorectal surgeon presenter(s), practice name/logo, physician photo(s)>
<Insert patient speaker(s) name(s), condition being treated with InterStim Therapy

3. Agenda Overview of Fecal Incontinence
Prevalence and Burden
Patient Quality of Life
Typical Treatment Pathway
Introduction to Sacral Neuromodulation
InterStim® Therapy for Bowel Control
Clinical Efficacy
Test for Potential Success
Practice Management Collaboration

4. Fecal Incontinence- More Common Than You Might Think
OAB1,2
Asthma3
Diabetes4
FI 5
Osteoporosis6
Alzheimer’s7
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
1. Stewart, W.F et al. Prevalence and Burden of Overactive Bladder in the United States.World Jrnl of Urol 2003:20:
2. Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20(6):
3. Centers for Disease Control and Prevention Website. Accessed October 18, 2010.
4. National Diabetes Information Clearinghouse Website. Accessed October 18, 2010.
5. Whitehead W.E. et al. Fecal Incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009; 137:
6. National Osteoporosis Foundation Website. Accessed October 18, 2010.
7. Alzheimer’s Association Website. Accessed October 18, 2010.

5. FI Impacts Quality of Life
Note: Higher scores translate to higher quality of life
FI Impacts Quality of Life
Fecal Incontinence Quality of Life Scale (FIQOL) Scores
Patients are particularly anxious about the unpredictability of episodes of fecal incontinence and often alter their social and professional activities to avoid embarrassment.(1 )
1. Wald A. Fecal Incontinence in Adults. New England Journal of Medicine. 2007;356(16):
Medtronic data on file. InterStim Therapy for Bowel Control Prospective Clinical Study. PMA#P

6. 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 #P 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): Bano F, Barrington JW. Prevalence of anorectal dysfunction in women attending health care
services. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(1):57-60.
2. PMA #P Damon 2006.
3. PMA #P Edwards NI, Jones D. The Prevalence of Faecal Incontinence in Older People Living at Home. Age Ageing.
2001;30(6):503-7. 
4. PMA #P 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):  

7. Typical FI Treatment Pathway

8. Optimal Medical Therapy
Conservative treatments include:
Dietary changes
Anti-diarrheal medications (e.g. loperamide)
Biofeedback
Discussion
When prescribing medical therapy for FI, what defines success/failure?
When adequate success is not achieved with one method, how many others do you typically try?
Optimal medical therapy comprised bulking
agents, pelvic floor exercises with a team of dedicated
physiotherapists, and dietary management on fluid and
fibers with a team of dieticians.

9. What’s Next for Patients?
My practice can offer further options for your patients who aren’t responding favorably to medical therapy:
Diagnostics
Endoanal ultrasound
Anorectal manometry
Therapies
Biofeedback/ physical therapy
InterStim Therapy
(sacral neuromodulation)
Other surgical options

10. Practice Management Collaboration
Implanter
Referring Physician
Collaborative Process to Optimize Patient Care
Initial Diagnosis
Conservative Treatments
Referral
Further Diagnostics
InterStim Trial Assessment
Implant & Device-related Follow-up
Ongoing General Patient Care

11. Sacral Neuromodulation
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. Kenefick NJ, Emmanuel A, Nicholls RJ. Effect of sacral nerve stimulation on autonomic nerve function. British Journal of Surgery. 2003; 90:  
* While the precise mechanism of action for InterStim Therapy has not been fully established, efficacy has been proven in clinical studies.

12. InterStim® Therapy 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.

13. InterStim 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
Manufactured by Medtronic, a global leader in medical device technology

14. More than 85,000 patients worldwide have received InterStim Therapy
Trust the Experience of Medtronic
Neuromodulation Therapies
OCD1
Parkinson’s Disease
Essential Tremor
Dystonia1
Chronic Fecal Incontinence, Overactive Bladder and Urinary Retention
Chronic Pain
Severe Spasticity
More than 85,000 patients worldwide have received InterStim Therapy
Gastroparesis1
Manufactured by Medtronic, a global leader in medical device technology
More than 85,000 patients worldwide have received InterStim Therapy
1Humanitarian Device Exemption (HDE): The effectiveness of these devices has not been demonstrated

15. Clinical Efficacy: Reduction in Episodes
InterStim Therapy Bowel Control Study
9.4
9.2
Mean Number of Weekly Incontinent Episodes
Modified Worst Case (MWC) (n=120)
3.1
1.9
Per-protocol (n=106)
Baseline
12 Months
Baseline
12 Months
1. Wexner SD, Coller JA, et al. Ann Surg Mar;251(3):441-9.
2. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2011.

16. Clinical Efficacy: Complete Continence
InterStim Therapy Bowel Control Study1,2
Tjandra RCT3
47%
41%
36%
Percent of Patients with a 100% Reduction in Accidents at 12 Months
Complete Continence = 100% reduction in accidents
Modifified worst case analysis (MWC) assumed no change for patients who were lost to follow-up or missing bowel diaries at the 12 month visit.
Per-protocol analysis (Completers analysis) was conducted for patients who had complete data both at baseline and at the 12 month visit.
Of special note is the fact that in the InterStim Therapy Bowel Control Study per-protocol analysis (n=106), 41% achieved complete continence, while 36% of the 120 patients in the intent-to-treat analysis completing the study achieved complete continence with the help of InterStim Therapy at the 12 month follow-up visit.
An intent-to-treat analysis was conducted which assumed no change for patients who
were missing bowel diaries at the 12 month visit unless a subsequent bowel diary was
available (modified worst-case analysis). Another per-protocol analysis was conducted
for patients who had complete data both at baseline and at the 12 month visit (completers
analysis)
MWC (n=120)
Per-protocol (n=106)
SNS group
(n=53)
1. Wexner SD, Coller JA, et al. Ann Surg Mar;251(3):441-9.
2. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2011.
3. 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):

17. Clinical Efficacy: Quality of Life
InterStim Therapy Bowel Control Study
1. Wexner SD, Coller JA, et al. Ann Surg Mar;251(3):441-9.

18. Adverse Events The most common adverse events (≥5%) reported
during the implant phase in clinical study included:1
Implant site pain
Paresthesia
Implant site infection
Change in sensation of stimulation
Urinary incontinence
Diarrhea
Many of the adverse events were successfully treated with medication, or reprogramming of the device.
The adverse events experienced in the study were all anticipated and within expectations based on previous experience with SNS.
Paresthesia: A skin sensation, such as burning, prickling, itching, or tingling, with no apparent physical cause.
For additional safety information, please refer to the Important Safety Information on handouts.
1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2011 18

19. I would consider testing InterStim Therapy with patients:
who have frequent bowel accidents
who have had bowel accidents for the past year or more
who have failed or are not candidates for conservative treatments such as diet modification, anti-diarrheal medications or biofeedback

20. Test for Potential Success
If indicated, your patients can try InterStim Therapy through a minimally invasive trial assessment
Patient trials the therapy for several days to determine whether symptom improvement is achieved
Provides informed choice for patient and doctor
Complications can occur with the trial assessment, including movement of the wire, technical problems with the device, and some temporary pain.

21. Overview of Trial Assessment
Through a minimally invasive procedure initiated in the office or in an outpatient hospital setting, a lead (thin wire) is placed near the sacral nerve (target S3).
The lead is connected to an external test stimulator worn on the patient’s waistband for several days.
The patient will be asked to record bowel behavior during the trial.
If patient experiences success, a neurostimulator may be implanted.
If patient does not experience success, a subsequent trial assessment may be recommended.
If patient still does not experience success, the lead will be removed and the patient will immediately be able to try other options.

22. Benefits of Referring Your Patients
Practical and extensive experience with InterStim Therapy
Offering your patients a minimally invasive option that can restore function1
We will collaborate to develop a follow-up plan once symptoms are successfully treated
1. Restored function as defined as a ≥50% reduction in weekly fecal incontinent episodes at 12 months post implant in clinical studies.

23. What Should You Tell Your Patients?
“I would like to refer you to a specialist who will evaluate your condition further and determine if InterStim Therapy might be an option for you.”
“The InterStim trial assessment will give you a chance to find out during a short trial period if long-term therapy may be a good option for you.”
“InterStim Therapy is an established therapy that is FDA approved for chronic fecal incontinence patients who have not benefited from conventional therapies.”
“InterStim is manufactured by Medtronic, a global leader in medical device technology.”
Scott’s tool

24. Summary
Fecal incontinence (FI) is very common and may impact a person’s quality of life.
Patients may be embarrassed to discuss FI symptoms and are often unaware of the new treatment options available.
If conservative treatments have been unsuccessful, refer patients to my practice to determine if InterStim Therapy is an option for them.
By partnering, you can expand patients’ treatment options and help find the best solution to manage their symptoms.
Together we can improve the quality of life for patients with bowel control problems.

25. Important Safety Information
InterStim® Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
The following Warning applies only to InterStim Therapy for Urinary Control:
Warning: This therapy is not intended for patients with mechanical
obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.
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 for Urinary Control and for Bowel Control: Diathermy. Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.
Precautions/Adverse Events:
For Urinary Control: Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 16; or for patients with neurological disease origins such as multiple sclerosis.
For Bowel Control: 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.
For Urinary Control and for Bowel Control: 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