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Experiences with Sacral Neuromodulation for Urinary Control and Bowel Control.

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Presentation on theme: "Experiences with Sacral Neuromodulation for Urinary Control and Bowel Control."— Presentation transcript:

1 Experiences with Sacral Neuromodulation for Urinary Control and Bowel Control

2 Agenda Prevalence & Impact of Overactive Bladder Prevalence & Impact of Chronic Fecal Incontinence InterStim Therapy for Urinary Control and Bowel Control –Efficacy & Safety Information –Test Procedure & System Overview –Medtronic Support Q&A

3 Overactive Bladder: Prevalence & Impact OAB 1 Asthma 2 Diabetes 3 Osteoporosis 4 Alzheimer’s 5 It is estimated that overactive bladder (OAB) affects more than 33 million people in the U.S. 1 OAB is more prevalent than many well-known diseases. 2-5 The total U.S. economic cost of OAB is $12.6 billion (year 2000 dollars) 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, National Osteoporosis Foundation Website. Accessed October 18, Alzheimer’s Association Website. Accessed October 18, Hu, TW et al. Costs of Urinary Incontinence and Overactive Bladder in the United States: A Comparative Study. Urology.2004;63(3):

4 Patient Survey Data* NAFC survey data found OAB patients seek treatment for the following reasons: –Frustration from living with the symptoms (78%) –Embarrassment (42%) –Physical discomfort (38%) 74% of surveyed OAB patients said they waited longer than they should have to seek treatment Only 20% of surveyed OAB patients are extremely satisfied with their current treatment * Source: Survey for the National Association for Continence (NAFC), sponsored by Medtronic, Inc. and conducted by Kelton Research. April The online survey was conducted using an invitation. Respondents were 611 nationally representative American women ages with overactive bladder.

5 Pharmacotherapy Persistence & Adherence > 70% discontinuation of prescribed therapy within 6 months > 80% discontinuation of prescribed therapy within 1 year > 50% chose not to restart their therapy after discontinuation 77 % 73 % 82 % OAB medications in the California Medicaid Program 1 1. Yu YF, Nichol MB, Yu AP, et al. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. Value in Health. 2005;8(4): Month Persistence & Adherence

6 1. Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009;15: Only 28% of patients on OAB medications remained persistent at 6 months Only 18% of patients on OAB medications remained persistent at 1 year Patients were less likely to remain on OAB medications than on any other drug class assessed Pharmacotherapy Persistence & Adherence OAB medications compared to those for several other chronic conditions OAB Medications Prostaglandins Analogs (indicated for glaucoma) Bisphosphonates (osteoporosis) Statins (hyperlipidemia) ARBs (hypertension) Oral antidiabetics (Type II) Persistent at 6 months Persistent at 1 year

7 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- More Common Than You Might Think

8 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 FI Impacts Quality of Life

9 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): Patient Education Needed

10 InterStim Therapy for Urinary Control and Bowel Control An established therapy that expands your 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

11 1. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, % of urge incontinence patients achieved clinical success 45% remained completely dry An additional 34% experienced  50% reduction in leaking 31% returned to normal voids (4 to 7 voids/day) An additional 33% experienced  50% reduction in number of voids 61% eliminated use of catheters An additional 16% experienced  50% reduction in catheterized urine volume 64% of urgency-frequency patients achieved clinical success 77% of urinary retention patients achieved clinical success 12-month clinical success for Urinary Control 1 InterStim Delivers Clinical Efficacy Urge Incontinence (n=38) Urgency- Frequency (n=33) Urinary Retention (n=38)

12 1. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, Urge Incontinence 1 Lasting Efficacy - Proven in a 5-year Clinical Trial 59% of urge incontinent patients achieved  50% reduction in leaks/day* 71% of those urge incontinent patients who reported heavy leaks at baseline achieved  50% reduction in leaks per day † * 59% in evaluable patient population (n=61) and 37% in intent-to-treat population (n=96) † 71% in evaluable patient population (n=49) and 42% in intent-to-treat population (n=84) Evaluable Patients – the subset of subjects for whom both baseline and 5-year data were available Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline InterStim Therapy for Urinary Control

13 Urgency-Frequency 1 56% of urgency-frequency patients achieved  50% increase in volume voided/void and improved degree of urgency * * 56% in evaluable patient population (n=18) and 40% in intent-to-treat population (n=25) 1. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, Evaluable Patients – the subset of subjects for whom both baseline and 5-year data were available Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline Lasting Efficacy - Proven in a 5-year Clinical Trial InterStim Therapy for Urinary Control

14 Urinary Retention 1 78% of urinary retention patients achieved  50% reduction in volume/catheterization* * 78% in evaluable patient population (n=23) and 58% in intent-to-treat population (n=31) 1. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, Evaluable Patients – the subset of subjects for whom both baseline and 5-year data were available Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline Lasting Efficacy - Proven in a 5-year Clinical Trial InterStim Therapy for Urinary Control

15 InterStim Therapy Bowel Control Study 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 Episodes InterStim Therapy for Bowel Control

16 Clinical Efficacy: Complete Continence 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 SNS group (n=53 ) InterStim Therapy for Bowel Control

17 Clinical Efficacy: Quality of Life InterStim Therapy Bowel Control Study 1 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 for Bowel Control

18 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.

19 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

20 Test for Potential Success Utilizes a tined lead that anchors in place Placed in the OR during an outpatient procedure You and your patient assess therapy effects 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. Advanced Evaluation

21 Complete InterStim System 1.Tined lead is placed parallel to the sacral (S2, S3, or S4) nerve. 2.Implantable neurostimulator generates mild electrical pulses that are delivered through the lead electrodes. 3.Clinician and patient programmers are used to set the parameters of the electrical pulses

22 The Pelvic Floor S3, the most distal common point of innervation for the bladder InterStim Therapy stimulates S3 or S4

23 Evaluating for InterStim: Treatment Algorithm Urge Incontinence & Urgency-Frequency Initial Screening Voiding Diary Urodynamic Work-up Behavioral Techniques Interventional Techniques Medications Continue as Appropriate InterStim Therapy Test Stimulation + - InterStim Therapy for Urinary Control

24 Evaluating for InterStim: Treatment Algorithm Urinary Retention Initial Screening Voiding Diary Urodynamic Work-up Rule Out Obstruction Continue as Appropriate InterStim Therapy Test Stimulation Medications and/or Catheterization + - InterStim Therapy for Urinary Control

25 Evaluating for InterStim: Treatment Algorithm Fecal Incontinence Initial Evaluation InterStim Implant Conservative Treatment Diet Modification Medication Behavioral Therapy Continue as Appropriate InterStim Therapy Test Evaluation 2 nd Test Evaluation + - InterStim Therapy for Bowel Control Other Surgical Treatment + -

26 InterStim Therapy for Urinary Control Coverage The coverage profile for sacral nerve stimulation is strong: –Medicare National Coverage Determination –Medicare Local Coverage Determinations (many retired) –Most commercial payers have coverage policies in place Common diagnoses include: – Retention of urine, unspecified – Incomplete bladder emptying – Other specified retention of urine – Urge incontinence – Urinary frequency 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.

27 The coverage profile for sacral nerve stimulation for fecal incontinence is developing: –Medicare Local Coverage Determinations (emerging) –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. InterStim Therapy for Bowel Control Coverage

28 Coding: CPT* Unique codes included on the 2010 Medicare Physician Fee Schedule for placement of electrodes on the sacral nerve: CPT 64561: Percutaneous implantation of neurostimulator electrodes; sacral nerve (transforaminal placement) (2010 Medicare Physician Payment National Average: Non Facility Setting: $1,046/Facility Setting: $417) CPT 64581: Incision for implantation of of neurostimulator electrodes; sacral nerve (transforaminal placement) (2010 Medicare Physician Payment National Average: Facility Setting: $826) CPT 64590: Insertion or replacement of peripheral neurostimulator pulse generator or receiver, direct or inductive coupling (2010 Medicare Physician Payment National Average: Facility Setting: $177) CPT 95972: Complex spinal cord or peripheral (except cranial nerve) neurostimulator pulse generator transmitter with intraoperative or subsequent reprogramming, first hour (2010 Medicare Physician Payment National Average: Non Facility Setting: $108/Facility Setting: $79) *CPT is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT) is a copyright 2009 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. Medicare payment is determined by multiplying the sum of the three RVUs (work, practice expense and malpractice) by the conversion factor. The conversion factor for CY 2010 is $ On June 25, 2010 the President signed into law HR This provides a 2.2% increase to the Physician Medicare Fee Schedule from June 1, 2010 through November 30, The bill may be found at: National average Medicare rates are shown here. Also note that any applicable coinsurance, deductible, and other amounts that are patient obligations are included in the payment amount shown. Multiple surgical procedure reductions may apply and are not calculated here.

29 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 Dictation Guides Prior Authorization Guides and Sample Letters of Medical Necessity

30 Additional Resources for Physicians Training & Education Patient Awareness & Education Resources Therapy Integration Consultation

31 Summary The condition of OAB is common and persistence and adherence with medication therapy is suboptimal Fecal incontinence is a hidden condition that can severely impact quality of life InterStim is an established therapy with proven long-term clinical efficacy A simple test procedure initiated in the office helps determine whether InterStim Therapy may help restore control over symptoms Reimbursement for InterStim is generally favorable Medtronic offers comprehensive support

32 Important Safety Information Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture. 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: 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.www.medtronic.com USA Rx Only. Rev 0409

33 Questions? To take the next step: Contact your local Medtronic Representative or Call the clinician services line:


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