About Medtronic InterStim Therapy for Urinary Control

If you've tried other treatments but are still suffering from bladder control problems, you might be relieved to hear about another option: InterStim Therapy.

What Is InterStim Therapy?

InterStim Therapy is a proven neuromodulation therapy that targets the communication problem between the brain and the nerves that control the bladder. If those nerves are not communicating correctly, the bladder will not function properly.

After talking with your doctor to see if InterStim therapy is right for you, you may decide to try InterStim Therapy by going through an evaluation. Based on the outcome of the evaluation, you and your doctor will determine the next steps for your treatment.

InterStim Therapy was created by Medtronic, and over 100,000 people worldwide have received InterStim Therapy. It has been FDA-approved since 1997 for urge incontinence and since 1999 for urinary retention and urgency-frequency. InterStim Therapy is not intended for patients with a urinary blockage.

Medicare and many other private insurance companies cover InterStim Therapy.

How Does InterStim Therapy Work?

InterStim Therapy works with the sacral nerves, located near the tailbone. The sacral nerves control the bladder and muscles related to urinary function.

It is believed that one possible cause of overactive bladder is miscommunication between the brain and the sacral nerves; when the brain and sacral nerves don't communicate correctly, the nerves will not tell the bladder to function correctly, which can cause bladder control problems.

The theory behind InterStim Therapy is that stimulation of the sacral nerves with mild electrical pulses reduces the signals to the nervous system which may be causing bladder control symptoms such as leaks, the sudden urge to go, or going too often.

How Effective Is InterStim Therapy?

In a long -term clinical study, it was found that 59% of patients with urge incontinence who received InterStim Therapy and completed follow-up with their doctors, had at least 50% fewer leaks per day when compared to the number of leaks before therapy.¹

It is important to know that individual results may vary and that not every patient who receives InterStim Therapy will receive the same benefits or experience the same adverse events as the patients in the clinical study. In addition to risks related to a surgical procedure, complications from this therapy can occur and may require surgery or cause return of symptoms.

How Can I Find Out If InterStim Therapy Will Work for Me?

During an evaluation, you'll have the opportunity to test InterStim Therapy without making a long-term commitment. The evaluation generally lasts several days. Before and during the evaluation, you'll be asked to track your symptoms to help determine how well InterStim Therapy works for you.

If you experience a significant reduction in your bladder control symptoms, you can decide whether or not to go on to long-term InterStim Therapy. 

Step 1: Medtronic InterStim Therapy Evaluation

If you've tried several treatments for bladder control problems without success, don't lose hope. Medtronic InterStim Therapy may be an option for you.

With InterStim Therapy's two-step process, you can test it out to see if it will work for you before making a long-term commitment. The testing period is called an "evaluation" or a "trial assessment."

Dr. Shusterman will discuss the evaluation procedure with you and the options for using either a temporary lead (a thin wire) or long-term lead for the evaluation.

How Will I Know If InterStim Therapy Works for Me?

You and Dr. Shusterman will decide together whether your evaluation was successful. The evaluation is considered a success if you experience a significant reduction in your symptoms.

For example, your evaluation may be considered a success if you went to the bathroom 20 times per day before the evaluation and went 10 or fewer times per day during the evaluation.

What Happens During the Evaluation?

The evaluation starts with a minimally invasive outpatient procedure usually done in my office. Anesthsia is not required and there is minimal to no pain during the procedure.

For the basic evaluation, which uses a temporary lead, your doctor will numb a small area of your upper buttock and insert a thin wire near your sacral nerves, located near the tailbone. The advanced evaluation uses a long-term lead that is fully implanted; one end of the lead is inserted near your sacral nerves. With both types of evaluations, the lead is connected to a small, external neurostimulator that you'll wear on your waistband like a pager. The stimulator generates mild electrical pulses that are carried to the sacral nerve by the lead.

The length of the evaluation may vary among doctors and depends on the type of evaluation you undergo. Generally, if the temporary lead is used, the evaluation period lasts from 3 to 7 days; if the long-term lead is used, the evaluation period may last up to 14 days. 

Complications can occur during the trial assessment, including movement of the wire, technical problems with the device, and some temporary pain. In most cases, these issues can be resolved, so talk to your doctor about your experience.

During the evaluation, you will need to use a symptom tracker to write down your urinary symptoms, such as how many times you go to the bathroom and whether you have leaks. You should be able to work and continue your normal activities, as long as you avoid lifting, bending or twisting movements. If you experience a significant reduction in your symptoms, you and your doctor can discuss long-term InterStim Therapy.

Step 2: Long-term InterStim Therapy

If you experience a significant reduction in your bladder control symptoms during the evaluation, you and your doctor can discuss long-term InterStim Therapy. InterStim Therapy is an FDA-approved treatment that has been shown to be safe and effective for men and women who have not had success with other treatments.

For long-term InterStim Therapy, the neurostimulator is placed under the skin of your upper buttock, above where you sit and below your waistline. The lead (thin wire) goes from the neurostimulator to a sacral nerve, located near the tailbone.

How Is Long-term InterStim Therapy (step 2) Different from the Evaluation (step 1)?

During the evaluation, you wear a temporary, external neurostimulator on your waistband. In long-term InterStim Therapy, the long-term neurostimulator is placed under your skin during a minimally invasive, outpatient procedure, so the neurostimulator is internal rather than outside your body. You control the neurostimulator with a hand-held programmer that works like a remote control to turn the stimulation up and down or on and off.

How Effective Is InterStim Therapy?

InterStim Therapy can eliminate or greatly reduce bladder control symptoms for people suffering from overactive bladder or urinary retention problems.¹

In a long-term clinical study, it was found that 59% of patients with urge incontinence who received InterStim Therapy and completed follow-up with their doctors, had at least 50% fewer leaks per day when compared to the number of leaks before therapy.¹

It is important to know that individual results may vary and that not every patient who receives InterStim Therapy will receive the same benefits or experience the same adverse events as the patients in the clinical study.

What Are the Risks of InterStim Therapy?

Implanting an InterStim Therapy system has risks similar to any surgical procedure, including swelling, bruising, bleeding, and infection. Dr. Shusterman is able minimize these risks due to his experience and excellent training.

Neurostimulation might cause you to experience some of these side effects:

• Pain at the implant site or new pain
• Infection or skin irritation
• Lead (thin wire) movement/migration
• Device problems
• Interactions with certain other devices or diagnostic equipment
• Undesirable changes in urinary or bowel function
• Uncomfortable stimulation (sometimes described as a jolting or shocking feeling)

Problems may be resolved with surgery, medical therapy such as drugs, or reprogramming. These events may also resolve over time. There is a possibility that some may remain unresolved.

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