Transcript InterStim Therapy for Urinary Incontinence

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
Fecal Incontinence (FI)
More Common Than You Might Think
35
30
25
20
15
10
5
0
1,2
OAB
OAB
Asthma 3
Asthma
Diabetes4
Diabetes
FI 5 FI
6
Osteoporosis
Osteoporosis
Alzheimer's 7
Alzheimer’s
• 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.
2.
3.
4.
5.
6.
7.
Stewart, W.F et al. Prevalence and Burden of Overactive Bladder in the United States.World Jrnl of Urol 2003:20:327-336
Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20(6):791-801.
Centers for Disease Control and Prevention Website. http://www.cdc.gov/asthma/brfss/03/lifetime/tableL1.htm. Accessed October 18, 2010.
National Diabetes Information Clearinghouse Website. http://www.diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people. Accessed October 18, 2010.
Whitehead W.E. et al. Fecal Incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009; 137:512-517.
National Osteoporosis Foundation Website. http://www.nof.org/node/40. Accessed October 18, 2010.
Alzheimer’s Association Website. http://www.alz.org/alzheimers_disease_facts_figures.asp. Accessed October 18, 2010.
Prevalence of: Urinary Retention, OAB, FI, and
Dual Incontinence (DI)
OAB
33 million1
FI
18 Million2
DI ~ 9.5
Million3
Urinary
Retention
??
1. Stewart, W.F et al. Prevalence and Burden of Overactive Bladder in the United States. World Jrnl of Urol 2003:20:327-336
2. Whitehead W.E. et al. Fecal Incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009; 137:512-517.
3. Coyne KS, et al. The prevalence of chronic constipation and faecal incontinence among men and women with symptoms of
overactive bladder. BJU Int. 2011 Jan;107(2):254-61.
Patient Education Needed
Studies suggest that only 15%– 45% of FI patients seek
treatment1,2.
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 disorder1
– 65% of patients with severe or major FI which
had an impact on the quality of life wanted help
with their symptoms2
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):37-43
2. 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.
FI Impacts Quality of Life
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.
Clinical Outcomes of Sacral
Neuromodulation for the Treatment of
Chronic Fecal Incontinence
Clinical Efficacy: Reduction in Weekly Incontinent
Episodes, 12 month results
Mean Number of Weekly
Incontinent Episodes
InterStim Therapy Bowel Control Study1,2
9.4
9.2
3.1
Modified
Worst Case
(MWC)
(n=120)
1.9
Per-protocol
(completers)
(n=106)
1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9.
2. Medtronic-sponsored research. InterStim Therapy Clinical Summary - 2011.
Percent of Patients with a 100%
Reduction in Accidents at 12 Months
Clinical Efficacy: Complete Continence
12 Month results
InterStim Therapy
Bowel Control Study1,2
Tjandra RCT3
47%
41%
36%
MWC
(n=120)
Per-protocol
(n=106)
SNM group
(n=53)
1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9.
2. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, 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):494-502.
Clinical Efficacy: Quality of Life
4.0
InterStim Therapy Bowel Control Study1
Mean FIQOL Score
(Completer's Analysis)
3.5
3.0
2.5
2.0
1.5
1.0
Lifestyle
Coping/Behavior
Depression/
Self-perception
Embarrassment
Baseline
(n= 119)
2.31
1.49
3 Months
(n=116)
3.22
2.64
6 months
(n=109)
3.26
2.69
12 Months
(n = 107)
3.36
2.77
2.53
3.33
3.48
3.54
1.6
2.73
2.75
2.81
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):441-449.
Adverse Events
The most common adverse events experienced
during clinical studies included:
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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. 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:
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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. 29:231-240 (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:
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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:
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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
Patient
Improvement
Conservative Treatment
Failed
Conservative
Treatment
•Diet Modification
•Medication
•Behavioral Therapy
Continue as
Appropriate
InterStim
Basic Evaluation
Positive
Negative
InterStim System Implant
Positive
InterStim
Advanced Evaluation
Negative
Consider Other Surgical
Treatment
http://professional.medtronic.com/pt/gastro/snm/edu/patient-selection/index.htm
Incorporating the InterStim System
into Your Practice
Patient Resources
• Patient information on InterStim
System on Medtronic website:
– http://www.medtronic.com/patients/bowelincontinence
– 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
Reimbursement Coverage
• 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:
– 787.60 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.
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 1-800-328-0810 and/or
consult Medtronic’s website at www.medtronic.com. Product technical manual must be reviewed prior to
use for detailed disclosure.
USA Rx Only. Rev 0409
Q & A Discussion