Answers to Common Questions

Following are some common questions about Medtronic Bladder Control Therapy (Sacral Neuromodulation), delivered by the InterStim® System. Don’t see your question here? Ask your doctor. If your doctor is not familiar with Medtronic Bladder Control Therapy, we can help you find a specialist who can answer your questions. Enter your ZIP code to view a list of specialists in your area.

1. Questions About Medtronic Bladder Control Therapy

Is Medtronic Bladder Control Therapy FDA-approved?

Yes. The InterStim System 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.

How effective is Medtronic Bladder Control Therapy?

Medtronic Bladder Control Therapy is clinically proven to be safe and effective for people who have not had success with other treatments. It has been used to treat 150,000 people worldwide.

In a long-term clinical study, it was found that 59% of patients with urge incontinence who received the InterStim System 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 Medtronic Bladder Control Therapy will receive the same benefits or experience the same adverse events as the patients in the clinical study. Refer to the important safety information for information on possible adverse events associated with Medtronic Bladder Control Therapy.

Is Medtronic Bladder Control Therapy for both men and women?

Yes. The InterStim System can be used to treat urinary control symptoms in both men and women.

Will my insurance cover the costs?

Medicare and many other private insurance companies cover Medtronic Bladder Control 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?

An evaluation period lets you test Medtronic Bladder Control Therapy to see if it will work for you before making a long-term commitment. 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 during the evaluation.

Learn more about the evaluation

How will Medtronic Bladder Control Therapy impact my daily life?

Medtronic Bladder Control Therapy can eliminate or greatly reduce bladder control symptoms for people suffering from overactive bladder (urge incontinence, urgency-frequency) or urinary retention problems.1 Medtronic Bladder Control 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.

Your doctor will inform you of precautions and activity restrictions related to Medtronic Bladder Control Therapy. You cannot have diathermy if you have an InterStim System.

Will Medtronic Bladder Control Therapy cure my condition?

No. Medtronic Bladder Control 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 Evaluation

How long is the evaluation period?

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

Will I have to miss work?

If your job doesn't require strenuous movement, bending, or twisting, you should be able to work throughout the evaluation. Talk with your doctor about your work situation.

How long will the evaluation procedure take?

Procedure time depends on the method your doctor uses. If your evaluation procedure takes place in the office, you should plan to be there for 60 to 90 minutes, although the procedure itself should take about 20 minutes. If your evaluation 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 20 minutes.

Will the procedure hurt?

Your doctor will give you anesthesia to make you more comfortable. Depending on where your procedure takes place – in the doctor's office, hospital or outpatient surgery center – 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?

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 can occur during the evaluation, 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. (See important safety information for possible adverse events.)

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 evaluation to record your urinary symptoms.

How will I know when to go to the bathroom during the evaluation? 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 evaluation. 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 Medtronic Bladder Control 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 evaluation is successful?

You and your doctor will decide together if you should move on to long-term Medtronic Bladder Control Therapy. Your doctor will look for results that clearly show a significant reduction in your symptoms. For example, you might go on to long-term therapy is you went to the bathroom 20 times per day before the evaluation and went 10 or fewer times during the evaluation.

What happens if I have a successful evaluation?

If your evaluation shows that Medtronic Bladder Control Therapy works for you, you and your doctor can discuss going on to long-term therapy. With long-term Medtronic Bladder Control 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 my symptoms don't significantly improve?

If your evaluation results do not clearly show a significant reduction in your symptoms, your doctor may talk with you about other options, which may include doing the advanced evaluation.

Will my insurance cover the evaluation?

Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. Your out-of-pocket costs will vary according to your insurance plan. Check with you insurance provider about the details of your coverage.

What resources are available for support when I undergo the evaluation?

Your doctor and his or her staff will be your main point of contact throughout the evaluation. You will also be able to call Medtronic Patient Services for answers about your InterStim System.

In addition, once you have a evaluation date, you'll be able to log into a website, www.everyday-freedom.com/trial, designed specifically for patients undergoing the evaluation. There you will find information to help you before and during the evaluation.

3. Questions About Long-term Medtronic Bladder Control Therapy

What is long-term therapy?

With long-term Medtronic Bladder Control Therapy, a small neurostimulator is placed under the skin of your upper buttock during a minimally invasive, outpatient procedure.

Learn more about long-term Medtronic Bladder Control Therapy

What size is the neurostimulator?

interstim2-w-quarter

The InterStim II neurostimulator 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 I have an InterStim System?

Getting an MRI head scan may be possible under specific conditions. For more information, talk with your InterStim doctor.

Is Medtronic Bladder Control Therapy reversible?

Yes. Medtronic Bladder Control Therapy is reversible and can be discontinued at any time by turning it off or having a surgical procedure to remove the neurostimulator.

What are the benefits of Medtronic Bladder Control Therapy?

Medtronic Bladder Control Therapy can eliminate or greatly reduce bladder control symptoms for people suffering from overactive bladder or urinary retention problems.

In a long-term clinical study, it was found that 59% of patients with urge incontinence who received the InterStim System 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 Medtronic Bladder Control Therapy will receive the same benefits or experience the same adverse events as the patients in the clnical study. Refer to the important safety information for information on possible adverse events associated with Medtronic Bladder Control Therapy.

What are the risks?

Implanting an InterStim System has risks similar to any surgical procedure, including swelling, bruising, bleeding, and infection. Talk with your doctor about ways to minimize these 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)

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. (See important safety information for additional information.) Please consult your doctor. This therapy is not for everyone. 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 Medtronic Bladder Control Therapy?

There are two different neurostimulators available for InterStim Therapy. While InterStim II (Model 3058) is smaller, InterStim (Model 3023) has a greater battery capacity.

What determines how long will the battery last?

Like any battery-powered device, the more it is used, the faster the battery power will be depleted. Battery life depends on many variables, such as program settings, on and off cycles, lead placement, etc. 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 an outpatient procedure.

What resources are available for support if I go on to long-term Medtronic Bladder Control Therapy?

Your doctor and his or her staff will be your main point of contact before and after your procedure for long-term therapy. You will also be able to call Medtronic Patient Services for answers about your InterStim System.

In addition, once you have a long-term procedure date, you'll be able to log into www.everyday-freedom.com/life, a website designed specifically for patients who go on to long-term InterStim Therapy. There you will find information to help you before and after the procedure, guidance on optimizing your InterStim System, and other information that will be helpful once you're receiving long-term therapy.

References

  1. Medtronic-sponsored reseach. InterStim Therapy Clinical Summary 2011.

Next: When to Consider Medtronic Bladder Control Therapy

Last updated: 6 Mar 2014