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.
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.
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."
How Will I Know If InterStim Therapy Works for Me?
You and your Urologist 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.
Neurostimulation might cause you to experience some of these side effects:
InterStim or Sacral Nerve Stimulation
IntroductionYou may be one of millions of people who suffer from frustrating and embarrassing bladder control problems such as retention and overactive bladder. Effects of bladder control problems can be devastating. These conditions prevent you from controlling when and how much you urinate and can make simple everyday activities a challenge and social lives very difficult. You may have to cut back on your hobbies or stop working. You may feel trapped by a fear of leaking accidents, the need to be close to a bathroom at all times, and an overall, preoccupation with your bladder. You can be any age to have bladder control problems. You have probably found that treatments such as drugs, behavior modification, diet changes, pelvic floor exercises or the use of a catheter to empty your bladder did not effectively treat your symptoms. In the past there were few options for patient who did not respond to these therapies. Now, however your doctor would like you to consider a therapy called sacral nerve stimulation (SNS). SNS involves the use of a device that can be thought of as a pacemaker for the bladder.
SNS therapy is not experimental. InterStim® Therapy (InterStim® is a registered trademark of Medtronic, Inc.), is a sacral nerve stimulation therapy made by Medtronic. It was approved by the U.S. Food and Drug Administration (FDA) in 1997 and has been used successfully to treat thousands of patients worldwide.
The intent of this handout is to help you understand the therapy. After you have read about the therapy, your doctor will help you make an informed decision about whether to proceed with a test to see if sacral nerve stimulation will work for you. If you want more information and/or plan to move forward with the therapy ask your doctor for a more detailed manual available from Medtronic.
The Urinary SystemHow Does the Urinary System Work?To understand how sacral nerve stimulation works, it is helpful to understand how the urinary system works. The urinary system includes two kidneys, two ureters, the bladder and the urethra (see Figure 1). The kidneys remove excess fluid and waste products from the blood and continuously produce urine. The ureters carry the urine to the bladder where the urine is stored. A muscle called a sphincter controls the opening and closing of the urethra (urine flows through the urethra during urination).
Figure 1. Anatomy of the Bladder Control System
When the bladder begins to fill with urine, a message is sent along the sacral nerves to the brain telling the brain that the bladder is getting full (see Figure 2). As the bladder fills, this message to the brain becomes stronger. When the message becomes strong enough, and you decide to urinate, your brain sends a message back to the bladder along the sacral nerves telling the bladder muscle to contract and the pelvic muscles to relax to allow urine to empty from the bladder (urination).
Urination is usually under voluntary control. This means that you decide when and where you want to urinate.
Figure 2. Communication Between the Brain and the Bladder
Why Do Some People Have Bladder Control Problems?
Sometimes, the two-way communication between the brain and bladder is disrupted. When this happens, patients may experience symptoms of bladder control problems. For many patients, sacral nerve stimulation may augment the communication between the brain and the bladder therefore reducing the symptoms associated with bladder control problems.
Sacral Nerve Stimulation (SNS)What is Sacral Nerve Stimulation Therapy?InterStim therapy is indicated for people with urinary retention and the symptoms of overactive bladder including urinary urge incontinence and significant symptoms of urgency, frequency in selected individuals.* At the heart of this therapy is an innovative and implantable neurostimulator about the size of a stop watch. The therapy uses a small implanted medical device to send mild electrical pulses to a nerve located just above the tail bone. These nerves are called sacral nerves. The sacral nerves [specifically S2, S3 and S4] activate or inhibited muscles and organs that contribute to urinary control-the bladder, sphincter and pelvic floor muscles. The electrical stimulation may eliminate or reduce certain bladder control functions in some people. This stimulation may facilitate the communication between the brain and bladder, and may relieve the symptoms of urinary retention or symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency in some patients.
InterStim therapy does not treat symptoms of stress incontinence. It has not been studied in pregnant patients, pediatric patients, patients with diabetes, or patients with multiple sclerosis. It is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer or urethral strictures.
How Will I Know if Interstim Therapy Will Work for Me?A physician's examination and evaluation can determine whether you are a candidate for InterStim therapy. If your bladder control problems are not effectively managed by more conservative treatments and you have an otherwise normally functioning urinary system you are a potential candidate.
SNS Therapy: Test Stimulation and ImplantSNS therapy is delivered in two procedures. The first is the test to see if the therapy will work for you. A test [temporarily test stimulation] is used before implantation of the InterStim Neurostimulator to see what the effect of the stimulation is on your symptom. If this test is positive the lead will stay in place and you will proceed to the permanent implant.
The next step, the implant of the SNS system, may be done after a successful test stimulation. It involves placement of a neurostimulator (electronics and battery). The implanted system is entirely under the skin.
How is the Test for SNS Therapy Done?Placing the Test Stimulation LeadThere are two types of leads used for test stimulation, a temporary lead or a long-term lead. Your doctor will explain the test stimulation procedure you will be undergoing.
The test stimulation lead is inserted in the doctor's office, surgical center, or hospital, depending upon the type of lead placed and your physician's preference. Your doctor will explain the type of anesthesia that will be used for your procedure. The medical team will make you as comfortable as possible during the procedure. You may be given pain medication and a sedative that will make your feel relaxed and drowsy, but able to cooperate during the procedure. Or, you may be given general anesthesia.
While you are lying on your stomach, your doctor will insert a lead and position it near a sacral nerve. The sacral nerves are located near the tailbone. During the procedure you may be asked to describe what you feel when the sacral nerve is stimulated. You may feel a "pulling", "tingling" or "tapping" sensation in your pelvic muscles and movement of your big toe. Women may feel a sensation in the vaginal area and men in the scrotum. Most likely you will go home the same day the lead is placed.
Figure 3. Test Stimulation Using the Temporary Lead
Figure 4. Test Stimulation Using the Long-term Lead
You will go home with a temporary system to "test" how the therapy works for you. The test stimulator generates mild, carefully controlled electrical pulses that are carried to the sacral nerve. These pulses cause the sensations of "pulling" or "tingling" or "tapping" in your pelvic area like you felt during the placement of the lead. Stimulation sensations vary from person to person, but should be comfortable. You will be shown how to control the intensity of stimulation and how to turn the system ON or OFF.
While undergoing the test, you will document your symptoms in a voiding diary. You should also limit your activities (no lifting, sexual intercourse). In the diary you will record how much and how often you urinate, any leaking episodes and any symptoms of urgency and frequency. If you have urinary retention and catheterize to empty your bladder, you will record the volume and time you catheterized. During the test you will know how stimulation feels and if it improves your symptoms. If your bladder control symptoms improved during the test stimulation, you and your doctor will decide if you want to continue with the therapy.
Your Follow-up Office VisitAfter the test, you will meet with your doctor to review your voiding diary and discuss whether your symptoms improved. Be aware that your bladder control symptoms will most likely return within a few hours after stopping the test stimulation.
If your symptoms improved - You and your doctor will decide if the SNS therapy is appropriate for you. Generally, if you have no problems and your symptoms improved during the test stimulation, you may be a potential candidate for SNS therapy.
If your symptoms did NOT improve - The test stimulation may be repeated. Or, you and your doctor may decide to try another procedure or different therapy.
How is the Implant for SNS Therapy Done?The InterStim® System for urinary control (made by Medtronic) is a sacral nerve stimulation system. The system includes a neurostimulator and lead that are surgically placed and programmers to adjust the stimulation settings.
Implanting the SNS DeviceThe implant procedure is performed in an operating room. As with the test stimulation procedure, the medical team will make you as comfortable as possible during the procedure. Your doctor will discuss the type of anesthesia to be used. You will either be given pain medication and a sedative or general anesthesia.
You will have one or two incisions. The incision made for the neurostimulator will be about 2 inches long; the other incision will be small, about ½ inch or less. The entire system will be under your skin.
If a temporary lead was used for the test stimulation:
Figure 5. Implant of Lead and Neurostimulator (battery and electronics)
You should be able to go home the same day of the procedure. Your incisions may feel sore and somewhat painful, especially during the first two weeks. Your doctor may prescribe a medication to control your discomfort. As the incisions heal, you should become more comfortable and will be able to gradually increase your activity level. Your doctor or nurse will give you directions to follow after the surgery.
Your physician turns on the neurostimulator after surgery. When the system is turned ON, you will feel a slight tingling, tapping or pulling sensation similar to what you felt during the test stimulation. The sensation should not be painful. The level of stimulation will be increased or decreased to achieve the best control of your symptoms.
Adjusting the Level of Stimulation at HomeAt home, you can control the level of stimulation and turn the SNS system ON and OFF with the patient programmer. The programmer is a hand-held device and is about the size of a cell phone (see Figure 6). When the programmer is held over the neurostimulator, the programmer "talks" to the neurostimulator to change the settings. (For more information, refer to technical manual or the Reference Card packaged with the InterStim System patient programmer.)
Figure 6. Patient Programmer
Clinical Study Results
Medtronic conducted an international, multi-center clinical study using Medtronic InterStim Therapy. Patients included in the study had symptoms of urge incontinence, urgency-frequency or retention.
The study showed that the InterStim Therapy successfully treated the symptoms of urge incontinence, urgency-frequency or retention. The results of the study are summarized in Figure 7.
* The multi-center study included 23 centers worldwide. A total of 581 patients were studied with 219 of them receiving InterStim Therapy.
** In patients with a baseline degree of >7 voids per day.
*** Success is defined as increased voided volume with the same or reduced degree of urgency.
Figure 7. Clinical Study Results
Problems or Complications
As with any surgical procedure, problems can occur. These problems may be resolved with reprogramming of the system, medications or surgery. The InterStim System can always be removed, if necessary.
The following events and approximate rate of occurrence occurred during the InterStim Therapy clinical study: pain where the neurostimulator is placed (15%), new pain (9%), movement of the lead (8%), infection (6%), sudden and brief increase in stimulation - sometimes described as shocking or jolting - (6%), pain at lead site (5%), significant change in bowel function (3%).
The following problems each occurred less than 2% of the time: technical problems, suspected device problem, change in menstrual cycle, adverse change in voiding function, persistent skin irritation, suspected nerve injury, and device rejection. The following problems each occurred less than 0.5% of the time: change in sensation of stimulation, grand mal seizure, hematoma or seroma, urinary hesitancy, neurostimulator turns on or off, lack of orgasm, lack of efficacy, numbness and tingling, foot/leg movement, strong anal sensation, unable to perceive stimulation, stress urinary incontinence, swollen feeling in abdomen, vaginal cramps, superficial connection, and possible skin perforation at neurostimulator.
You should be aware that none of these problems in the clinical study resulted in permanent injury to patients. Additional information on clinical studies can be found at www.interstim.com
It is important to note that since this clinical study was conducted, changes in InterStim Therapy and surgical techniques have been made. For instance, the neurostimulator is now commonly placed in the upper buttock, rather than in the abdomen as in the original study. In addition, a new lead was developed which made the procedure much less invasive.
Candidates for SNS TherapyWho Are Candidates for SNS Therapy?SNS is intended for patients who have failed or could not tolerate more conservative treatments. Bladder control problems that may improve with SNS therapy include:
What Other Limitations Apply to SNS Therapy?Some known limitations for this therapy include: a failed test stimulation, or inability to use the patient programmer. Patients with other stimulation devices such as a pacemaker may also not be candidates for SNS.
Inform anyone treating you that you CANNOT have any shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) anywhere on your body because you have an implanted neurostimulation system. Energy from diathermy can be transferred through your implanted system, and can cause tissue damage, resulting in severe injury or death.
Is SNS a Cure for Bladder Control Problems?As with any therapy, your own individual results may vary. While many patients implanted with InterStim Therapy experienced relief of many of their symptoms, the therapy will not result in complete improvement or a cure.
You should know that many patients have experienced positive results and experienced an improved quality of life after having the InterStim Therapy implanted. To learn more about the therapy, visit www.interstim.com or ask your doctor for the Medtronic patient manual and a brochure to read stories from patients who decided to have the InterStim System implanted.