Transcript InterStim® Therapy for Bowel Control

Partnering for
Pelvic Health
EXPANDING OPTIONS FOR
BOWEL CONTROL
Welcome
• <Insert name(s) of physician presenter(s),
practice name/logo, physician photo(s)>
• <Insert patient speaker(s) name(s),
condition being treated with InterStim Therapy
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
Fecal IncontinenceMore Common Than You Might Think
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OAB
OAB
Asthma 3
Asthma
Diabetes 4
Diabetes
FIFI5
Osteoporosis 6
Osteoporosis
Alzheimer's
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
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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.
FI Impacts Quality of Life
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#P080025.
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:
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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.
Gastroenterol Clin Biol. 2006;30(1):37-43. 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 #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.
Typical FI Treatment Pathway
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?
What’s Next for Patients?
My practice can offer
InterStim Therapy to
those patients who
aren’t responding
favorably to medical
therapy.
Practice Management Collaboration
Initial
Diagnosis
Conservative
Treatments
Ongoing General
Patient Care
Collaborative
Process to
Optimize
Patient Care
Device-related
Follow-up
InterStim
Implant
Referring Physician
Referral
InterStim
Trial Assessment
Implanter
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;
90:1256-1260.
* While the precise mechanism of action for InterStim Therapy has not been fully established, efficacy has been proven in clinical studies.
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.
InterStim Therapy Benefits
1. Minimally invasive option that does not preclude
use of alternative treatments
2. Proven clinical safety and efficacy
3. Trial assessment provides informed choice for
patient and doctor prior to implant
4. Manufactured by Medtronic, a global leader in
medical device technology
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
1Humanitarian Device
Gastroparesis1
Exemption (HDE): The effectiveness of these devices has not been demonstrated
Clinical Efficacy: Reduction in Episodes
Mean Number of Weekly
Incontinent Episodes
InterStim Therapy Bowel Control Study
10
9
8
7
6
5
4
3
2
1
0
9.4
9.2
3.1
Modified
Worst Case
(MWC)
(n=120)
1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9.
2. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2011.
1.9
Per-protocol
(n=106)
Percent of Patients with a 100%
Reduction in Accidents at 12 Months
Clinical Efficacy: Complete Continence
50
InterStim Therapy
Bowel Control
Study1,2
40
30
Tjandra RCT3
47%
41%
36%
20
10
0
MWC
(n=120)
Per-protocol
(n=106)
SNS 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 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):494-502.
Clinical Efficacy: Quality of Life
InterStim Therapy Bowel Control Study
Mean FIQOL Score
(Completers Analysis)
4.0
3.5
3.0
2.5
2.0
1.5
1.0
Baseline
(n=119)
3-Months
(n=116)
6-Months
(n=109)
12-Months
(n=107)
24-Months
(n=68)
36-Months
(n=30)
Scale 1 - Lifestyle
2.31
3.22
3.26
3.36
3.32
3.52
Scale 2 - Coping/Behavior
1.49
2.64
2.69
2.77
2.69
2.7
Scale 3 - Depression/SelfPerception
2.53
3.33
3.48
3.54
3.58
3.77
Scale 4 - Embarrassment
1.6
2.73
2.75
2.81
2.76
2.95
1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9.
Adverse Events
The most common adverse events (≥5%) reported
during the implant phase in clinical study included:1
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Implant site pain
Paresthesia
Implant site infection
Change in sensation of stimulation
Urinary incontinence
Diarrhea
For additional safety information, please refer to the
Important Safety Information on handouts.
1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2011
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
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.
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.
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
Initial
Diagnosis
Collaborative
Process to
Optimize
Patient Care
Device-related
Follow-up
1. Restored function as defined as a ≥50% reduction in weekly fecal incontinent episodes at 12
months post implant in clinical studies.
Conservative
Treatments
Ongoing General
Patient Care
InterStim
Implant
Referring Physician
Referral
InterStim
Trial Assessment
Implanter
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.”
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.
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 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