Answers to Common Questions
Following are some common questions about InterStim Therapy. Don’t see your question here? Ask your doctor, find a doctor in your area who offers Medtronic InterStim Therapy or ask our panel of experts.
1. Questions About Medtronic InterStim Therapy
Is InterStim Therapy FDA approved?
Yes. InterStim Therapy was approved by the FDA in 1997 for urge incontinence and in 1999 for urinary retention and significant symptoms of urgency-frequency. It has been available in the US for over a decade.
Has InterStim Therapy been studied?
Yes. InterStim Therapy has been shown to be safe and effective for people who have not had success with other treatments. It has been used to treat thousands of people worldwide.
In a clinical study, doctors found that nearly half of patients with urge incontinence who received InterStim Therapy were completely dry after 6 months, and many others have experienced greatly reduced symptoms.1
Side effects may include implant site pain, skin irritation, infection, device problems, and movement of the wire. These conditions were generally resolvable in a clinical study.
See important safety information for possible adverse events.
Will my insurance cover the costs?
Medicare in all 50 states and Puerto Rico, as well as many private insurance companies, cover InterStim Therapy. Your out-of-pocket costs will vary according to your insurance plan. Check with you insurance provider about the details of your coverage.
How will I know if it will work for me?
A trial assessment period lets you test InterStim Therapy to see if it will work for you before making a long-term commitment. The trial assessment is considered a success if you experience a 50% or greater reduction in your symptoms.
For example, your trial would be considered a success if you went to the bathroom 20 times per day before the trial and went 10 or fewer times during the trial.
How will InterStim Therapy impact my daily life?
InterStim Therapy can eliminate or greatly reduce bladder control symptoms for people suffering from overactive bladder (urge incontinence, urgency-frequency) or urinary retention problems.1 InterStim Therapy may allow you to regain your everyday freedom, so you can stop worrying about your bladder control problems and return to the life you once enjoyed.
Will InterStim Therapy cure my condition?
No. InterStim Therapy is a treatment for bladder control problems, not a cure. If the neurostimulator were turned off or removed, your symptoms would return.
2. Questions About the Trial Assessment
How long is the trial assessment period?
The trial assessment generally lasts 3 to 7 days. However, the length of the assessment period may vary among doctors. Talk with your doctor about what he or she recommends for your individual situation.
Will I have to miss work?
People generally go back to work 1 or 2 days after the trial procedure. You should be able to work throughout the trial, if your job doesn’t require strenuous movement. Talk with your doctor about your work situation.
How long will the trial assessment procedure take?
Procedure time depends on the method your doctor uses. If your trial procedure takes place in the office, you should plan to be there for 60 to 90 minutes, although the procedure itself should take less than 30 minutes. If your trial procedure takes place in a hospital or outpatient surgery center, you should plan to be there for about 4 hours, though the procedure should take about 30 minutes.
Will the procedure hurt?
Your doctor will give you anesthesia to make you more comfortable. Depending on the method your doctor uses for the trial procedure, you will be given either local or intravenous anesthesia. In the vast majority of cases, you will not need general anesthesia to "put you to sleep." Tell your doctor if you feel any discomfort during the procedure.
Is there any recovery time needed?
Most people go back to work 1 or 2 days after the trial assessment procedure. As with any medical procedure, it might take a few days for you to feel back to your normal self.
What does the stimulation feel like?
Stimulation varies from person to person, but most people describe it as a slight "pulling" or a "tingling" sensation in the pelvic area. It should not be painful.
What are the risks?
Complications are rare. Side effects may include pain, skin irritation, infection, device problems, and movement of the wire. These conditions were generally resolvable in a clinical study.1 Talk with your doctor about what to expect.
What happens after the procedure?
You will go home with a small neurostimulator that you will wear on your waistband or put in your pocket. You will need to fill out a symptom tracker during the trial to record your urinary symptoms.
How will I know when to go to the bathroom during the trial? Do I need to turn the neurostimulator on and off?
You will not need to take any special steps to go to the bathroom during the trial. The neurostimulator works with your nerves to tell your brain when you need to go to the bathroom, so you should be able to empty your bladder normally. If InterStim Therapy is working for you, you should see a decrease in the number of times you go to the bathroom if you have overactive bladder, or a reduction in the number of times you need to catheterize if you have urinary retention.
How will I know if the trial is successful?
You and your doctor will decide together whether the trial is successful. The trial is considered a success if you experience a 50% or greater reduction in symptoms. For example, your trial would be considered a success if you went to the bathroom 20 times per day before the trial and went 10 or fewer times during the trial.
What happens if I have a successful trial?
If your trial is successful, you and your doctor can discuss going on to long-term InterStim Therapy. With long-term InterStim Therapy, a small neurostimulator is placed about an inch under the skin of your upper buttock during a minimally invasive, outpatient procedure.
What happens if I don’t have a successful trial?
If your trial is not successful, your doctor may talk with you about other options, which may include doing another trial assessment using a different approach.
Will my insurance cover the trial assessment?
Medicare in all 50 states and Puerto Rico, as well as many private insurance companies, covers InterStim Therapy. Your out-of-pocket costs will vary according to your insurance plan. Check with you insurance provider about the details of your coverage.
Is the trial assessment the same as a clinical trial?
No. The trial assessment is a time period (generally 3 to 7 days, but check with your doctor) during which you try InterStim Therapy.
A clinical trial is a controlled study of human subjects to collect information about the safety and effectiveness of a drug or medical device. Clinical trials were conducted for InterStim Therapy before it was approved by the FDA in 1997.
3. Questions About Long-term InterStim Therapy
What is long-term InterStim Therapy?
With long-term InterStim Therapy, a small neurostimulator is placed under the skin of your upper buttock during a minimally invasive, outpatient procedure.
What size is the neurostimulator?
The InterStim Therapy neurostimulator (actual size) is about 2" wide and about ¼" thick. Some doctors describe it as being the size of a pocket watch.
Where is the neurostimulator placed?
The neurostimulator is placed under the skin of your upper buttock, above where you sit and below your waistline. A thin wire goes from the neurostimulator to a sacral nerve, located beneath the tailbone.
Will anyone be able to see the neurostimulator? Will I be able to feel it?
In most cases, the outline of the neurostimulator cannot be seen. Patients have reported that they can wear a bikini or tight clothing without their neurostimulator showing. In most cases, you cannot feel the neurostimulator if you run your hand over your skin—you would have to press down on the area to feel it.
How do I control the stimulation?
You control the neurostimulator with an external patient programmer that works like a remote control to turn the stimulation up and down or on and off.
Can I get an MRI after receiving long-term InterStim Therapy?
Medtronic recommends that an MRI should not be prescribed for anyone with an implanted InterStim Therapy system. Exposure to an MRI can potentially injure the patient or damage the neurostimulator.
If you require an MRI, talk to your doctor who is familiar with you and your InterStim Therapy system. Your doctor may recommend other forms of diagnostic tests such as CT scans, x-rays, or ultrasounds that are effective but have less risk of affecting the device.
Before you undergo any tests or treatments, always tell your medical and dental professionals that you have an implanted InterStim Therapy System.
Is InterStim Therapy reversible?
Yes. InterStim Therapy is reversible and can be discontinued at any time by turning it off or having a procedure to remove the neurostimulator.
What are the benefits of lnterStim Therapy?
InterStim Therapy can eliminate or greatly reduce bladder control symptoms for people suffering from overactive bladder or urinary retention problems.
In a clinical study, doctors found that nearly half of patients with urge incontinence who received InterStim Therapy were completely dry after 6 months, and many others have experienced greatly reduced symptoms.1
What are the risks?
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
In most cases, these issues can be resolved, so talk to your doctor about your experience. (See important safety information for possible adverse events.) This therapy is not for everyone. Please consult your doctor. A prescription is required.
How often will I need to see my doctor?
Follow-up schedules vary. You will likely see you doctor about a week after your procedure. If all goes well, you will see your doctor again in 1 to 2 months. In the first month, you may need more visits to optimize the stimulation to best control your symptoms. After initial adjustment period, you will probably see your doctor every 6 to 12 months.
Is there only one type of neurostimulator available for InterStim Therapy?
There are two types of neurostimulators used for InterStim Therapy. The size of InterStim II is 1.7" x 2.0" x 0.3", with a battery life of 3 to 5 years, and the slightly larger InterStim is 2.2" x 2.4" x 0.4", with a battery life of 5 to 9 years. Both models are nonrechargeable, and the neurostimulator will need to be replaced before the battery loses power.
What determines how long will the battery last?
Battery life depends on the settings you use to control your symptoms; with a higher setting, you will need to replace the battery sooner. At your regular check-ups, your doctor or nurse can check on the status of your battery. Replacing the battery requires replacing the neurostimulator, which is done during a short, minimally invasive, outpatient procedure.
References
- Single-stage Implant Clinical Trial, Medtronic Clinical Summary for InterStim Therapy.
Next: When to Consider InterStim Therapy
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