Download InterStim ® Therapy for Urinary Control

Partnering for
Pelvic Health
EXPANDING OPTIONS FOR URINARY CONTROL
Cherri E.
Receiving InterStim® Therapy since 2008
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
Agenda
• Overview of Bladder Dysfunction
– Prevalence and Burden
– Patient Quality of Life
– Typical Treatment Pathway
• Introduction to Sacral Nerve Stimulation
– InterStim® Therapy for Urinary Control
– Test for Potential Success
– Clinical Efficacy
• Practice Management Collaboration
Bladder Dysfunction –
More Common Than You Might Think
35
30
25
20
15
10
5
0
OAB 1,2
OAB
•
•
•
Asthma 3
Asthma
Diabetes 4
Diabetes
Osteoporosis 5
Osteoporosis
Alzheimer's 6
Alzheimer’s
It is estimated that more than 33 million adults in the United States –
one in six – suffer from bladder control problems.1,2
OAB is more prevalent than many more well-known diseases.3-6
The total U.S. economic cost of OAB is $12.6 billion (year 2000 dollars).7
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. Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20(6):791-801.
3. Centers for Disease Control and Prevention Website. http://www.cdc.gov/asthma/brfss/03/lifetime/tableL1.htm. Accessed October 18, 2010.
4. National Diabetes Information Clearinghouse Website. http://www.diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people. Accessed October 18, 2010.
5. National Osteoporosis Foundation Website. http://www.nof.org/node/40. Accessed October 18, 2010.
6. Alzheimer’s Association Website. http://www.alz.org/alzheimers_disease_facts_figures.asp. Accessed October 18, 2010.
7. Hu, TW et al. Costs of Urinary Incontinence and Overactive Bladder in the United States: A Comparative Study.j.urology.2003:10.037:461-465.
OAB Impacts Patient Quality of Life
• National Association for Continence (NAFC)
survey participants reported that their OAB
caused them to:
–
–
–
–
Alter their behavior in social situations
Refrain from both normal and intense physical activity
Refrain from physical intimacy
Cancel social plans
• Primary reasons patients seek OAB treatment:
– Frustration from living with the symptoms (78%)
– Embarrassment (42%)
– Physical discomfort (38%)
* Source: Survey for the National Association for Continence (NAFC), sponsored by Medtronic, Inc. and
conducted by Kelton Research. April 2009. The online survey was conducted using an email invitation.
Respondents were 611 nationally representative American women ages 40-65 with overactive bladder.
Patient Education Needed
NAFC survey data suggests that patients may benefit
from information about OAB and the various treatment
options available
• 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
• Of those patients surveyed who have never sought out
treatment for OAB:
– 26% didn't know about available treatment options
– 23% said they are embarrassed to discuss their OAB
* Source: Survey for the National Association for Continence (NAFC), sponsored by Medtronic, Inc. and
conducted by Kelton Research. April 2009. The online survey was conducted using an email invitation.
Respondents were 611 nationally representative American women ages 40-65 with overactive bladder.
Typical OAB Treatment Pathway
OAB Pharmacotherapy
• Anticholinergics
–
–
–
–
–
–
Oxybutynin (Ditropan®, Oxytrol®, Gelnique®)
Tolterodine (Detrol®)
Solifenacin (VESIcare®)
Darifenacin hydrobromide (ENABLEX®)
Trospium chloride (Sanctura XR®)
Fesoterodine (Toviaz®)
• Discussion
– When prescribing anticholinergics, what defines
success/failure?
– When adequate success is not achieved with one
anticholinergic, how many others do you typically try?
Patients Often Dissatisfied with Meds
100%
Discontinue + no restart
Discontinue + restart
80%
77%
60%
82%
73%
40%
Persistence & adherence
of OAB medications in the
California Medicaid Program1
•
> 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
20%
0%
Tolterodine
Oxybutynin ER
Oxybutynin
(n = 1093)
(n = 524)
(n = 812)
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):495-505.
Even Compared to Many Other Types
Medication adherence & persistence for several
common chronic conditions compared1
Persistent at 6 months
Persistent at 1 year
• Only 28% of patients on
OAB medications remained
persistent at 6 months
• Only 18% remained
persistent at 1 year
• Patients were less likely to
remain on OAB medications
than on any other drug class
assessed
OAB
Medications
Prostaglandins Bisphosphonates
Statins
(osteoporosis)
(hyperlipidemia)
Analogs
(indicated for glaucoma)
ARBs
(hypertension)
Oral
antidiabetics
(Type II)
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;15:724-736.
What Are Your Patients Saying?
Comments such as these may indicate an interest in
alternative treatment options:
•
“I’m really constipated all the time.”
•
“My eyes are so dry that I had to buy eye drops.”
•
“My mouth is so dry that I have to drink more liquids.”
•
“The side effects are almost as bad as my bladder problems.”
•
“I seem to have a lot of side effects.”
•
“None of these medications seem to work.”
•
“The medications work a little but I still have a lot of problems.”
•
“I wish I could find something that works better.”
•
“I have to take so many pills already.”
•
“Isn’t there something else I can try?”
•
“Is this the only option that I have?”
What’s Next for Refractory Patients?
My practice can offer further options for your patients
who aren’t responding favorably to medical therapy:
Diagnostics
• Cystoscopy
• Urodynamics
Therapies
•
•
•
•
Biofeedback/Physical Therapy
Slings
PTNS
Sacral Nerve Stimulation
Practice Management Collaboration
Initial
Diagnosis
Behavioral Therapies
& Anticholinergics
Ongoing General
Patient Care
Collaborative
Process to
Optimize
Patient Care
Implant &
Device-related
Follow-up
InterStim
Test
Referring Physician
Referral
Further
Diagnostics
Implanter
Sacral Nerve Stimulation
• Focuses mild electrical pulses on the
nerves that control the pelvic floor and
lower urinary tract 1,2*
• Offers control of symptoms through
direct modulation of the nerve activity,
making it different from oral medications
that target the muscular component of
urinary control1,2*
1. Griebling TL. Neuromodulation: mechanisms of action. In: Kreder K, Dmochowski R, eds. The Overactive
Bladder: Evaluation and Management. London, England: Informa UK Ltd; 2007:293-302.
2. Leng WW, Chancellor MB. How sacral nerve stimulation neuromodulation works. Urol Clin N Am. 2005;32:11-18.
* While the precise mechanism of action for InterStim has not been fully established, efficacy has been proven
in clinical studies.
InterStim® Therapy
Sacral Nerve Stimulation for Urinary Control
An established therapy that expands your
treatment options for patients with
urge incontinence, urgency-frequency,
or urinary retention* who have failed
or could not tolerate more
conservative treatments.
* InterStim Therapy is not intended for patients with mechanical obstruction
such as benign prostatic hypertrophy, cancer, or urethral stricture.
InterStim® Benefits
•
•
•
•
•
•
Proven long-term clinical safety and efficacy
Test provides informed choice for patient and doctor
prior to implant
External programming enables the physician and
the patient to adjust level of stimulation as needed
Does not preclude use of alternative treatments
Manufactured by Medtronic, a global leader in
medical device technology
More than 85,000 patients worldwide have received
InterStim Therapy
Trust the Experience of Medtronic
Neuromodulation Therapies
OCD1
Parkinson’s Disease
Essential Tremor
Dystonia1
Severe Spasticity
Chronic Pain
Gastroparesis1
Overactive Bladder and
Urinary Retention
1Humanitarian
Device Exemption (HDE): The effectiveness of these devices has not been demonstrated
I would consider testing InterStim with patients:
• who have symptoms of urge incontinence,
urgency-frequency and urinary retention.
• who have failed or could not tolerate conservative
treatments such as behavioral and diet modification
and anticholinergic drugs.
• with mixed incontinence where stress incontinence
is not the primary complaint*.
• with urinary retention who do NOT have
mechanical obstruction such as benign prostatic
hypertrophy, cancer or urethral stricture.
* InterStim Therapy is not indicated for treatment of stress incontinence.
Test for Potential Success
If indicated, your patients can try InterStim® Therapy
through a minimally invasive test procedure
• Patient tests the therapy for 3-7 days to determine
whether symptom improvement is achieved
• Provides informed choice for patient and doctor
Complications can occur with the test procedure, including
movement of the wire, technical problems with the device,
and some temporary pain.
Overview of Test Procedure
Peripheral Nerve Evaluation (PNE)
• Through a minimally invasive procedure initiated in the office, a
temporary lead is placed near the sacral nerve (S2, S3 or S4).
• The lead is connected to an external test stimulator worn on
the patient’s waistband for 3-7 days.
• The patient will be asked to record voiding behavior during
the test.
• If patient experiences success, a permanent lead and a
neurostimulator may be implanted.
• If patient does not experience success, a subsequent test
procedure utilizing a tined lead to reduce lead migration 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.
12-Month Clinical Efficacy
Urge
Incontinence
(n=38)
UrgencyFrequency
Urinary
Retention
(n=38)
(n=33)
79% of urge incontinence patients achieved clinical success
• 45% remained completely dry
• An additional 34% experienced  50% reduction in leaking
64% of urgency-frequency patients achieved clinical success
• 31% returned to normal voids (4 to 7 voids/day)
• An additional 33% experienced  50% reduction in number of voids
77% of urinary retention patients achieved clinical success
• 61% eliminated use of catheters
• An additional 16% experienced  50% reduction in catheterized urine volume
Source: Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.
5-Year Clinical Efficacy: Urge Incontinence
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
•
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)
Source: Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.
5-Year Clinical Efficacy: Urgency-Frequency
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
56% of urgency-frequency patients achieved  50%
increase in volume voided/day and improved degree of
urgency*
* 56% in evaluable patient population (n=18) and 40% in intent-to-treat population (n=25)
Source: Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.
5-Year Clinical Efficacy: Urinary Retention
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
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)
Source: Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.
Adverse Events
The most common adverse events experienced
during clinical studies included:
•
•
•
•
•
•
•
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 handouts.
Benefits of Referring Your Patients
• Specialized training and education
• Practical and extensive experience
with technological advances and
interventions related to OAB
• Offer your patients
more options
• We will collaborate
to develop a
follow-up plan
once symptoms
are successfully
treated
Initial
Diagnosis
Behavioral Therapies
& Anticholinergics
Ongoing General
Patient Care
Collaborative
Process to
Optimize
Patient Care
Implant &
Device-related
Follow-up
InterStim
Test
Referring Physician
Referral
Further
Diagnostics
Implanter
What Should You Tell Your Patient?
• “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.”
• “InterStim Therapy is an established therapy that has been
FDA approved since 1997 for patients who are not satisfied
with conventional therapies.”
• “InterStim is manufactured by Medtronic, a global leader in
medical device technology.”
• “Prior to long-term therapy, InterStim is tested for
3-7 days so you can assess whether the therapy
is beneficial. This test is initiated through a
minimally invasive in-office procedure.”
• “InterStim is covered by Medicare and most
major insurance companies.”
Summary
• OAB is very common and may impact a person’s
quality of life.
• Patients may be embarrassed to discuss OAB
symptoms and are often unaware of the various
treatment options available.
• If conservative treatments have been unsuccessful,
refer patients to my practice for advanced diagnostic
and alternative treatment options.
• 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 bladder 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.
Contraindications: Diathermy. Patients who have not demonstrated an appropriate
response to test stimulation or are unable to operate the neurostimulator.
Warning: This therapy is not intended for patients with mechanical obstruction such as
benign prostatic hypertrophy, cancer, or urethral stricture.
Precautions/Adverse Events: 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. 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