INTERSTIM ® THERAPY for Urinary Control

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

Urinary Control System

How the Urinary System Works Ureter Bladder Bladder neck Urinary sphincter Urethra Kidney

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

Types of Bladder Control Problems Urinary Retention Overactive Bladder –Urge Incontinence –Urgency-Frequency Stress Incontinence

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

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

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

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

Wide Range of Treatment Options Diet modification Pelvic Floor Exercises Biofeedback Medications Catheterization InterStim Therapy Surgery

Medications don’t 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.

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

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)

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

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

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

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

How effective is this therapy? 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 > 50% reduction in the amount of urine emptied from the bladder by catheter Results 12 Months After Surgery Medtronic clinical study data on file