Questions About InterStim Therapy Trial Assessment (Perc Test)
The trial assessment generally lasts 3 to 7 days.
Procedure time depends on t. 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 about 30-45 minutes. If your trial procedure takes place in a hospital or outpatient surgery center, you should plan to be there for about 4 hours.
If your job doesn’t require strenuous movement, bending, or twisting, you should be able to work throughout the trial assessment. Talk with Dr. Sweeten about your work situation.
Local anesthesia with or without sedation will be given to make you more comfortable. You will not need general anesthesia to “put you to sleep.” You will be able to tell Dr. Sweeten if you feel any discomfort during the procedure.
As with any medical procedure, it might take a few days for you to feel back to your normal self.
Stimulation varies from person to person, but most people describe it as a slight “pulling” or a “pulsing” sensation in the pelvic area. It should not be painful.
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.
You will go home with a small neurostimulator that you will wear on your waistband like a pager or put in your pocket. You will need to fill out a symptom tracker during the trial to record your urinary symptoms.
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 get up at night or less urgency or a reduction in the number of times you need to catheterize if you have urinary retention.
You and Dr. Sweeten will decide together if you should move on to long-term InterStim Therapy. We 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 trial and went 10 or fewer times during the trial assessment.
Once you and Dr. Sweeten have determined that the trial was successful then you can move forward to long-term InterStim Therapy. With long-term InterStim Therapy, a small internal neurostimulator is placed about an inch under the skin of your upper buttock during a minimally invasive, outpatient procedure.
If your trial assessment results do not clearly show a significant reduction in your symptoms, Dr. Sweeten may talk with you about other options, which may include doing another trial assessment using a different approach.
Medicare and many other private insurance companies cover InterStim Therapy. Your out-of-pocket costs will vary according to your insurance plan. Our office will check with your insurance provider about the details of your benefits.
No. The trial assessment is a time period (generally 3 to 5 days) 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 the FDA approved it in 1997.
Your doctor and his or her staff will be your main point of contact throughout the trial assessment. In addition, once you have a trial assessment procedure date, you’ll be able to log into a website, www.everyday-freedom.com/trial, designed specifically for patients undergoing the trial assessment. There you will find information to help you before and during the trial assessment.
Questions About Long-term InterStim Therapy
With long-term InterStim Therapy, a small internal neurostimulator is placed under the skin in the fatty part of the upper buttock during a minimally invasive, outpatient procedure.
The InterStim II neurostimulator (actual size) is about 2″ wide and about 1/4″ thick. Typically described as being the size of a pocket watch or half dollar.
The neurostimulator is placed under the skin of your upper buttock, above where you sit and below your waistline. A thin flexible lead goes from the neurostimulator to a sacral nerve, located beneath the tailbone.
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.
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.
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.
Yes. InterStim Therapy is reversible and can be discontinued at any time by turning it off or having a surgical procedure to remove the neurostimulator.
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.
Implanting an InterStim Therapy system has risks similar to any surgical procedure, including swelling, bruising, bleeding, and infection. Talk with Dr. Sweeten about ways to minimize these risks if it is a concern.
– 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.
Follow-up schedules vary. You will likely return about 2 weeks after your procedure. If all goes well, you will see Dr. Sweeten 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 4 to 8 months.
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, Dr. Sweeten’s staff can check on the status of your battery. Replacing the battery requires replacing the neurostimulator, which is done during an outpatient procedure.