INTERSTIM

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INTERSTIM THERAPY for Urinary Control
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What are Bladder Control Problems?

• Broad range of symptoms
• May leak small or large amount of urine
• May leak frequently
• May be unable to completely empty the bladder, or
  may be unable to urinate at all
• Multiple causes
• Injury
• Side effects from certain medications
• Diseases
• Infection
• Bearing children

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Urinary Control System
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How the Urinary System Works
Kidney
Ureter
Bladder
Bladderneck
Urinarysphincter
Urethra
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How Common are Bladder Control Problems?

• Over 33 million people suffer from bladder
  control problems in the United States alone!
• Can affect both women and men
• It can affect people of any age it is not just
  a normal part of aging

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Types of Bladder Control Problems

• Urinary Retention
• Overactive Bladder
• Urge Incontinence
• Urgency-Frequency
• Stress Incontinence

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Urinary Retention

• Occurs when you cannot fully empty your bladder.
  
• Symptoms
• Need a catheter to pass urine
• Produce only a weak, dribbling stream of urine
• Not have a sensation when your bladder is full
• Store increasingly large volumes of urine

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Urge Incontinence

• A form of overactive bladder.
• Symptoms
• Lose urine as soon as you need to go to the
  bathroom
• Leak urine when you drink even a small amount of
  liquid or when you hear or touch running water
• Have frequent leaking episodes

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Urgency-Frequency

• Also a form of overactive bladder.
• Symptoms
• Have frequent, uncontrollable urges to urinate
• Go to the bathroom more than seven times a day
• Feel that your bladder is never completely empty

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Stress Incontinence

• Involuntary loss of urine resulting from
  contraction of the abdominal muscles.
• Symptoms
• Leak urine when you sneeze, cough or laugh
• Experience leakage when exercising, bending or
  lifting
• Leak urine when climbing stairs or getting up
  from a chair
• Go to the bathroom often to avoid accidents

InterStim Therapy does not treat stress
incontinence
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Wide Range of Treatment Options

• Diet modification
• Pelvic Floor Exercises
• Biofeedback
• Medications
• Catheterization
• InterStim Therapy
• Surgery

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Medications dont work for everyone.

• Voiding requires a coordinated activity between
  the nerves and the muscles that control voiding
• While medications are thought to address the
  muscles, InterStim Therapy is thought to address
  the nerves.
• If medications were not the answer for you,
  InterStim Therapy may provide relief.

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InterStim Therapy for Urinary Control

• FDA-approved treatment for urinary control
  problems in people who have not had success with-
  or could not tolerate- more conventional
  treatments.
• Over 21,000 patients implanted worldwide

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How Does InterStim Therapy Work?

• A small stimulation system is implanted under the
  skin, usually in your upper buttock
• The device provides electrical stimulation of the
  sacral nerves to help restore more normal voiding
  function
• This therapy is reversible at any time

(double-click on picture to play animation)
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Who Can Benefit from InterStim Therapy?

• People with non-obstructive urinary retention
• People with symptoms of overactive bladder,
  including urinary urge incontinence and
  urgency-frequency
• People whose symptoms did not improve with more
  conventional treatments, such as medications
• People who cannot tolerate the side effects from
  medications
• People who respond well to the test stimulation
  and can operate the system

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Test Stimulation

• A test is done to determine how you will respond
  to the implanted device
• Performed in the office or surgery center
• A lead is placed under the skin just above the
  tailbone
• Lead is connected to an external device worn on
  your belt for a period of 3-7 days
• The decision for implantation of the permanent
  device will be made based on your response to the
  test stimulation

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Implantation of the InterStim System

• Procedure done in operating room using general or
  local anesthesia
• Stimulator is implanted and connected to a lead
  that will stimulate your sacral nerve
• Stimulator is usually placed in upper buttock
• The entire InterStim System will reside under
  your skin
• Entire procedure takes 1-1 ½ hours

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InterStim Patient Programmer

• You will be given a programmer to take home with
  you to control the stimulator
• The programmer can turn the system on and off and
  adjust the level of stimulation

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How effective is this therapy?
Results 12 Months After Surgery

• Urge Incontinence (38 patients)
• 45 of patients completely dry
• Further 34 had 50 or greater reduction in
  symptoms
• Urgency-Frequency (33 patients)
• 31 back to normal (4-7 per day)
• Additional 33 had a 50 or more reduction in
  number of urinations
• Retention (38 patients)
• 61 stopped catherization
• 16 had gt 50 reduction in the amount of urine
  emptied from the bladder by catheter

Medtronic clinical study data on file