interstim therapy
What Is InterStim Therapy?
- Medtronic InterStim Therapy helps control bladder problems by sending mild electrical pulses to target the communication problem that exists between the sacral nerves (located near the tailbone) and the brain.
- In some people, the brain and sacral nerves, which control the bladder, do not communicate correctly, so the nerves cannot tell the bladder how to function properly.
- Doctors have referred to InterStim Therapy as a pacemaker for the bladder.
InterStim Therapy: Indications and Recommended Use
- InterStim Therapy was approved by the Food and Drug Administration (FDA) in 1997 for urge incontinence and in 1999 for urinary retention and significant symptoms of urgency-frequency.
- InterStim Therapy is recommended for patients with bladder control problems who have not had success with common treatments such as Kegel exercises, fluid and diet changes, physical therapy and/or medication.
- InterStim Therapy is not intended for patients with a urinary blockage.
Benefits and Risks
- InterStim Therapy provides another treatment option for bladder control problems, such as leaking, urgency and frequency. Medtronic’s medical technologies help make it possible for millions of people to resume everyday activities, return to work and live better, longer.
Many people treated with InterStim Therapy have reported improved quality of life and freedom to live without worry of leaks.
- Treatment with InterStim Therapy begins with a three to seven-day trial assessment so a patient can test the therapy without making a long-term commitment. If good results are achieved from the trial, the patient may receive long-term InterStim Therapy (an implantable neurostimulator). Even after implantation, the treatment is reversible and can be discontinued by turning off or removing the device at any time.
- Implanting an InterStim Therapy system has risks similar to any surgical procedure, including swelling, bruising, bleeding, and infection.
- In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, 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), and others. For additional information, see Important Safety Information. Patients should always discuss the potential risks and benefits with a physician. This therapy is not for everyone. A prescription is required.
Patients Who Should Consider InterStim Therapy
- Patients should consider InterStim Therapy when other treatments have not been successful and their bladder control problems have affected their lifestyle to the point where they have curtailed activities such as traveling or going to the gym.
- InterStim Therapy does not treat every type of bladder control problem. It is not intended for patients with conditions such as benign prostatic hyperplasia (BPH), cancer, urethral stricture, or stress incontinence, all of which may produce urinary symptoms.
How InterStim Works
- Treatment with InterStim Therapy involves trial assessment, surgical implant and long-term follow up.
- Trial Assessment. During a 3-7 day trial assessment, which can occur in a simple outpatient procedure in a urologist’s, gynecologist’s or urogynecologist’s office, the doctor numbs a small area and inserts a thin, flexible wire near the sacral nerves. The wire is taped to the skin and connected to a small external stimulator that is worn on the waistband. The stimulator sends mild electrical pulses to the sacral nerves. In a successful trial, patients should experience significant improvement in their symptoms.
- Surgical Implant. Following a successful trial, the temporary flexible wire is removed and replaced with a permanent flexible wire, or lead. Once in place, the other end of the lead is passed under the skin and connected to a small stimulator. The stimulator itself — about the size of a pocket watch — is implanted under the skin in the upper buttock. This minimally invasive procedure is often performed as an outpatient procedure while the patient is under local anesthesia.
- Long-Term Follow Up. Following implant, the neurostimulator is activated. The neurostimulator sends mild electrical pulses via the lead to the sacral nerve. Physicians can adjust the stimulation to optimize the therapy for each patient, and follow-up examinations usually occur every six to 12 months to monitor the therapy’s effectiveness. A patient programmer (like a remote control) also allows patients to adjust the intensity of the stimulation and gives patients some control in managing their therapy.
Cost and Coverage
- Most private insurance companies have a written policy providing coverage for InterStim Therapy. Medicare has a national policy providing coverage for all approved indications.
Bladder Control Problems Affect Millions1
- As many as 33 million Americans suffer from bladder control problems.
- One in four women between the ages of 30 and 59 has experienced an episode of urinary incontinence.
- Similarly, it is estimated that one in four women over age 60 have urinary incontinence.2
- While bladder control problems are not a normal part of the aging process, prevalence rates increase with age.
- Bladder control problems cost more than $16 billion in the United States to care for each year.
- First-line treatments such as Kegel exercises, fluid and diet changes and medication fail to relieve the symptoms adequately for many patients who suffer from bladder control problems.
Bladder Control Problems May Have an Impact on Quality of Life3
- People with bladder control problems often struggle with simple everyday activities, such as working, shopping, traveling in a car or seeing a movie, for fear of embarrassing wetting episodes or not being near a restroom.
- People with bladder problems often suffer from poor quality of life including embarrassment, loss of self-esteem, sleep deprivation, and depression or anxiety.
- In severe cases, individuals with bladder control problems may no longer be able to work.
Definitions of Conditions Affecting Bladder Control4,5
These are generally accepted definitions of conditions.
- Overactive Bladder: the involuntary contraction of the muscle in the wall of the urinary bladder, which causes a sudden and unstoppable need to urinate
- Urgency-Frequency: frequent need to urinate – in severe cases, as many as 40 times per day
- Non-Obstructive Urinary Retention: the inability to completely empty the bladder
- Urinary Incontinence: the involuntary loss of urine from the bladder
- Mechanical Obstructions: conditions such as benign prostatic hyperplasia (BPH), cancer, or urethral strictures that can interfere with the ability to pass urine
Causes and Contributing Factors
- In some people, the brain and sacral nerves, which control the bladder, do not communicate correctly, so the nerves cannot tell the bladder how to function properly.
- Pregnancy and childbirth, obesity, weak pelvic muscles, diabetes, bladder cancer or stones, and neurological disorders can contribute to overactive bladder.
- Certain medications, high calcium levels, constipation, or inactivity can also contribute to the risk.
Treatment Options
- Non-Surgical and Behavioral Techniques include pelvic muscle exercises (e.g., Kegel), biofeedback, bladder training, pads, injectable urethral bulking agents (e.g., collagen), pessaries and catheters.
- Medications may effectively inhibit contractions of an overactive bladder in some patients or relax or tighten muscles. These drugs may cause side effects such as dry mouth, constipation, eye problems or urine buildup, which in some cases cannot be tolerated.
- Sacral Nerve Stimulation through InterStim Therapy is an FDA approved treatment that may be an option for patients who have not had success with or could not tolerate more conservative treatments. Medtronic InterStim Therapy helps control bladder problems by sending mild electrical pulses to target the communication problem that exists between the sacral nerves (located near the tailbone) and the brain. In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, 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), and others. For additional information, see Important Safety Information.
- Non-Reversible Surgery includes augmentation, diversion or myomectomy, bladder neck suspension, vaginal slings and artificial urinary sphincters.
[1] Overview: Urinary Incontinence in Adults: Clinical Practice Guidelines. Agency for Healthcare Policy and Research. http://www.ahrq.gov/clinic/uiovervw.htm. Accessed on August 12, 2008.
2 Incontinence. MenopausRX. http://www.menopauserx.com/health_center/health_Incontinence.htm. Accessed on August 21, 2008.
3 Urinary Incontinence in Adults: Acute and Chronic Management. Agency for Healthcare Policy and Research. http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat6.section.10049. Accessed on August 12, 2008.
4 Urinary Incontinence in Adults: Acute and Chronic Management. Agency for Healthcare Policy and Research. http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat6.section.10049. Accessed on August 12, 2008.
5 About Overactive Bladder. www.interstim.com. Accessed on August 12, 2008.
Version: February 2010