Interstim Therapy Surgical Procedure
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- Interstim therapy uses mild electrical pulses to stimulate nerves in the lower back, just above the tailbone. These nerves are called sacral nerves.
- The sacral nerves stimulate muscles and organs that contribute to urinary control.
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The test stimulation procedure may take place in the doctor's office or hospital.
To prepare for the procedure, the nurse/doctor will:
- Position you face down on an exam table.
- Place Drapes leaving the lower back, buttocks, and feet exposed.
- Use an antiseptic to clean the lower back and buttocks.
- Push on your lower back to identify important landmarks on the sacrum, a triangular bone in the lower back.
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During the Test Stimulation Procedure, the Doctor Will:
- Numb the area around the sacrum with a local anesthetic.
- Insert a needle through a hole in the sacrum (foramen) and position its tip near a sacral nerve.
- Connect a test stimulator to the needle. With the stimulation turned on, you may feel a pulling" or "tingling" sensation in your pelvic muscles or big toe. Women may feel a sensation in the vaginal/rectal area, men in the scrotum/rectal area.
- Insert a wire through the needle and repeat stimulation.
Note: More than one test stimulation needle and wire may be used during the procedure.
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After the Test Stimulation Wire is Placed:
- The wire is coiled and secured to the back with a sterile dressing
- The wire is connected to a small test stimulator that is worn on a belt.
- A small rubber pad is secured to the skin and must be worn during the trial period.
- An x-ray may be taken to confirm the position of the lead.
During the Trial Period:
- The system is worn for up to 7 days (determined by your doctor).
- You will be provided with a diary and instructed to record your symptoms.
- If the test stimulation improves your symptoms, you and your doctor may decide to proceed with an InterStim System implant.
Note: If the test stimulation is inconclusive, your doctor may suggest repeating the procedure.
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The following are the general steps in the surgery for the implant of the InterStim System. Your doctor's method may be different.
During the Operation, the Doctor:
- Makes an incision (cut) through the skin over the sacrum.
- Inserts the lead through the incision and places its tip near the sacral nerve.
- Makes a pocket for the neurostimulator under the skin in a place that is chosen before surgery.
- Makes a tunnel from the lead to the pocket and passes the extension through the tunnel.
- Connects the lead and the extension.
- Attaches the extension to the neurostimulator.
- Places the neurostimulator into the pocket.
- Closes the incisions and covers them with sterile dressing.
- When the surgery is complete, all parts of the system lie under the skin.
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Programming the InterStim System
- Physician programmer The doctor uses the physician programmer to program neurostimulator settings and check neurostimulator information.
- Patient programmer The hand-held patient programmer turns the neurostimulator ON and OFF and adjusts the stimulation level within the limits set by the doctor. It also can check the status of the neurostimulator battery.
- Control magnet The control magnet turns the neurostimulator ON and OFF. You and your doctor or nurse will adjust the stimulation settings to maintain the most effective control of your symptoms without discomfort. You may need to make several visits to fine-tune the settings that are best for you.
InterStim® Therapy for Urinary Control: Patients should always discuss potential risks and benefits with a physician.
The Medtronic InterStim® System for Urinary Control is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency-frequency in patients who have failed or could not tolerate more conservative treatments.
Patients are contraindicated for implant of the InterStim System if they have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.
Safety and effectiveness have not been established for: bilateral stimulation, patients with neurological disease origins such as multiple sclerosis, pregnancy and delivery, or for pediatric use under the age of 16. System may be affected by or adversely affect cardiac pacemakers or therapies, cardioverter defibrillators, diathermy, electrocautery, external defibrillators, ultrasonic equipment, radiation therapy, magnetic resonance imaging (MRI), theft detectors and screening devices. Problems related to the therapy, device, or procedure can include: pain at the implant sites, lead migration, infection or skin irritation, technical or device problems, transient electric shock, adverse change in bowel or voiding function, numbness, nerve injury, seroma at the neurostimulator site, change in menstrual cycle, and undesirable stimulation or sensations.
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The Interstim therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.
Federal law (USA) restricts this device to sale by or on the order of a physician.
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