InterStim Training

1
InterStim Therapy Theory Technique Course
Section 3 Where Does InterStim Therapy Belong
in the Treatment Algorithm?
2
Treatment Algorithm to Evaluate for InterStim
Therapy Urinary Urgency-Frequency and Urge
Incontinence
Initial Screening
Voiding Diary
Urodynamic Work-up
Behavioral Techniques Interventional
Techniques Medications
-

Continue as Appropriate
InterStim Therapy Test Stimulation
3
Treatment Algorithm to Evaluate for InterStim
Therapy Urinary Retention
Initial Screening
Voiding Diary
Urodynamic Work-up
Rule Out Obstruction
Medications and/or Catheterization
-

Continue as Appropriate
InterStim Therapy Test Stimulation
4
Patient Selection Who Benefits Most?
Patients younger than 55 yrs are more likely to
discontinue drug therapy.
Adjusted Odds Ratio of age as a predictor of
treatment drug discontinuation1
(referent)
n 1447
1. Campbell, U., et al. Survey assessment of
continuation of and satisfaction with
pharmacological treatment for urinary
incontinence. Value Health 11 726-732, 2008.
5
Patient Selection Who Benefits Most?
Patients younger than 55 yrs may have the best
chance for remaining completely dry with sacral
neuromodulation.
InterStim Therapy Patients with NO daily
leakage episodes1
n 55
1. Amundsen, C.L. et al. Sacral Neuromodulation
for Intractable Urge Incontinence Are There
Factors Associated With Cure? Urology 66
746-750, 2005.
6
Mixed Urinary Incontinence
In an independent investigation1 evaluating
women with refractory, nonobstructive urinary
urge incontinence after stress incontinence
surgery, factors predictive of a positive
response to SNS therapy included

• Patients younger than 55 (p 0.01)
• Test stimulation performed within 4 years of the
  surgical procedure (p 0.01)
• Evidence of pelvic floor muscle activity (p
  0.03)

InterStim Therapy is not indicated for the
treatment of stress incontinence.

1. Sherman, N. et al. Sacral Neuromodulation for the
   Treatment of Refractory Urge Incontinence after
   Stress Incontinence Surgery. Am J Obstet
   Gynecol. 2005 Dec193(6)2083-7.

7
Discuss

• What are you doing now with patients who fail
  behavioral and drug therapy?
• How do you stay connected with patients who are
  dissatisfied with medications?
• When and how do you introduce patients to test
  stimulation?
• How many anticholinergics are prescribed before
  test stimulation is conducted?

8
Patient Selection Discuss

• Urodynamic workup - factors to consider
• Post-sling
• Denovo symptoms following surgery
• Pelvic pain
• Age
• Patients with neurogenic conditions
• Pediatric use in patients 16 and older
• Retention
• Review the InterStim Therapy Indications
  Insert 2005 for a list of indications, warnings
  and precautions.

9
Clinical Results 12 month Efficacy
Urge Incontinence1,245 completely dry34
experienced 50 reduction in leaking
episodes Urgency Frequency1,331 returned to
normal voids (4 to 7 voids/day)33 experienced
50 reduction in voids Rentention161 eliminated
use of catheters 16 experienced 50 amount of
urine emptied from catheter usage
Urge Incontinence1,2 n 38
UrgencyFrequency1,3 n 33
Retention1,4 n 38
1. Medtronic Sponsored Research InterStim Therapy
Clinical Summary Insert 2006 2. Schmidt RA, Jonas
U, et al. J Urol. 1999 Aug162(2)352-7. 3.
Hassouna MM, Siegel SW, et al. J Urol. 2000
Jun163(6)1849-54.
10
Clinical Results 5-Year Efficacy

• Purpose
• This post-approval, non-randomized, multicenter
  study provided data on the long-term effects of
  sacral nerve stimulation for the treatment of
  urinary urge incontinence, urinary
  urgency-frequency, and urinary retention in
  patients who had failed or could not tolerate
  more conservative treatments. The study took
  place at 17 centers in the United States, Canada,
  and Europe.
• Results
• The study demonstrated that InterStim Therapy can
  be a long-term solution for patients with
  overactive bladder or non-obstructive urinary
  retention.  Based on the subset of study subjects
  for whom both baseline and five-year data were
  available (i.e., the evaluable sample),
  improvement ranged from 39 to 78, depending on
  the outcome assessed.  If all implanted study
  subjects are considered (i.e., the
  intent-to-treat sample) and missing five-year
  data are imputed using baseline values (or, in
  the absence of baseline values, from the mean
  baseline of all subjects with baseline values),
  the results range from 28 to 58, depending on
  the outcome assessed. 
• See InterStim Therapy Clinical Summary for
  complete details.

11
5-Year Clinical EfficacyUrge Incontinence 60
month post-implant results
Intent to Treat Patients defined as all
implanted study subjects, including those who
dropped out and were imputed as no change from
baseline.
Intent to Treat
Evaluable Patients
71
Evaluable Patients defined as the subset of
subjects for whom both baseline and 5-year data
were available.
59
Patients
42
37
n 96
n 84
n 61
n 49
1 Excludes patients who reported no heavy leaks
at baseline and at 60 months post-implant
12
5-Year Clinical EfficacyUrge Frequency 60
month post-implant results
Intent to Treat
Evaluable Patient
56
56
40
40
39
Patients
28
n 25
n 25
n 25
n 18
n 18
n 18
13
5-Year Clinical EfficacyUrinary Retention 60
month post-implant results
Intent to Treat
Evaluable Patient
78
65
58
Patients
48
n 31
n 23
n 23
n 31
14
Urge Frequency QOL at 6 months1,2
Stimulation group n 23
Control group n 20
PF, physical function RP, role physical BP,
bodily pain GH, general health V, vitality SF,
social function RE, role emotional MH, mental
health
Average SF-36 Score
p lt 0.0001
p 0.01
p 0.17
p 0.002
p 0.01
p 0.003
p 0.01
p 0.01
1. Medtronic Sponsored Research InterStim Therapy
Clinical Summary Insert 2006 2. Hassouna MM,
Siegel SW, et al. J Urol. 2000 Jun163(6)1849-54.
15
Adverse Events
Adverse events reported with InterStim Therapy
for Urinary Control include

• Pain at the implant sites
• Lead migration
• Infection or skin irritation
• Technical or device problems
• Transient electrical shock
• Adverse change in bowel or voiding function

• Numbness
• Nerve injury
• Seroma at the neurostimulator site
• Change in menstrual cycle
• Undesirable stimulation or sensations

Medtronic Sponsored Research InterStim Therapy
Clinical Summary Insert 2006
16
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