The doctors featured here have at least 10 years of experience with Medtronic Bladder Control Therapy (Sacral Neuromodulation), delivered by the InterStim® System. Here, they answer some of their patients' common questions about the therapy.
How do you describe Medtronic Bladder Control Therapy to your patients?
Dr. Noblett says: "When I describe the therapy, I liken it to a cardiac pacemaker. Nobody thinks twice about pacemakers. They're done as an outpatient procedure and pacemakers have few complications. Like the heart, the bladder is an involuntary muscle, and when there's abnormal signaling between the brain and bladder, the bladder is overactive or underactive. Medtronic Bladder Control Therapy regulates the signals between brain and bladder to help restore normal function."
Dr. Bologna says: "When I go over the range of treatment options with my patients, I usually say, 'There's even a pacemaker for your bladder.' My brief overview starts out with the fact that InterStim has been around for many years. Then I explain how the therapy sends a constant signal to the bladder to get it to calm down. I also emphasize that you don't have to do anything once it's implanted. You don't to turn the unit on and off to urinate, and you shouldn't even notice the stimulation for it to be working."
When should patients consider Medtronic Bladder Control Therapy?
Dr. Noblett says: "InterStim Therapy isn't a first line treatment. Usually I'll recommend other therapies first, such as medications or pelvic floor retraining. But if a patient hasn't met her goals – either her symptoms haven't improved or she is experiencing intolerable side effects – then InterStim Therapy should be considered.
"Early on, I outline all the options for patients, so they are aware of the whole treatment ladder and can make a choice for what would work best with their lifestyle. The reason I present all options is that, if the initial therapy they choose isn’t meeting their goals, they know there are other options available. What I try to impart to patients is that bladder problems, while not life threatening, are a quality of life issue, and quality of life is extremely important."
Dr. Bologna says: "When patients' bladder control problems are to the point where they have to change their lifestyle or they have stopped doing things they like to do such as traveling or going to the gym, then it is time to consider something else. Typically, we try patients on at least two different medications, have them learn pelvic floor exercises, keep a diary and modify their diet. If there isn't any improvement, then we suggest InterStim Therapy."
What are some of the benefits of Medtronic Bladder Control Therapy over other treatments?
Dr. Noblett says: "InterStim Therapy has a trial period. Most procedures have no trial – you either do them or you don't. The InterStim evaluation is like trying a medication. You try it for a period of time and decide if it meets your goals. If your goals are met, you proceed with completion of the therapy. If your goals are not met or if at any point in the future you change your mind, the InterStim System can be turned off or removed."
Dr. Siegel says: "The unique thing about InterStim Therapy is that we can test it first. If we try it and it doesn't make enough of a difference in your symptoms to make you any better, then we simply remove the wire. There's nothing left inside your body, and we really haven't done anything to you in any way to change your functions. You really haven't lost anything if you try it and it doesn't seem to improve your symptoms."
What are the risks involved in Medtronic Bladder Control Therapy?
Dr. Siegel says: "To me, the biggest risk is the disappointment patients will feel if the therapy isn't right for them. I try to prepare them for this, but it's hard not to get your hopes up. There are also risks such as infection or discomfort."
Because the InterStim System is surgically placed, surgical complications such as infections are possible. Device complications can also occur and may require surgery. Please talk to your doctor to fully understand the risks and benefits. For a complete list of adverse events associated with Medtronic Bladder Control Therapy, please refer to the important safety information.
What success rate do you see with your patients?
Dr. Noblett says: "My own data shows a bit lower success rate than the average, most likely because we have cast a wider net to include patients we may not have thought about including before. One thing that surprises me the most is you can't predict who will do well and who won't."
Dr. Siegel says: "I tell my patients that the likelihood that this is going to provide a benefit is about 60% to 70%. In other words, it's more likely than not that this is going to help, but there's still a significant chance that it might not be a benefit. I always emphasize that, because usually when patients get to the point of the evaluation, they have a lot riding on the line, at least emotionally, and you have to understand that there's a chance that it might not work and that we would have to find other solutions to help manage their problem."
What do you tell patients who are concerned about using a medical device to treat their bladder control problems?
Dr. Noblett says: "Some patients say, 'I don't want to have a foreign body in me.' I try to make them more comfortable with the concept by using examples of other medical devices. I point out that knee and hip joint replacements are foreign bodies, and they are also used to improve quality of life. I think part of their concern is that they aren't used to thinking of a device as a treatment for incontinence. I explain that now pacemaker-like devices are used to treat pain, movement disorders, gastro-intestinal disorders and to deliver medications, among other things."
Dr. Bologna says: "People are a little leery of implantable devices. I tell them how small it is, the location, that it can't be seen, that it's a minimally invasive procedure, and that the therapy has been around for more than 10 years. I also emphasize that there is a testing phase to find out if this is going to work before moving forward."
What do you tell patients who are concerned about the device showing?
Dr. Bologna says: "I tell my patients that we place the device in the fatty layer under the skin and muscles. We try to put it deep enough that it doesn't change the contour of your backside, and if you're in a bathing suit, no one's going to know that it's there. It's certainly not like having your wallet in your back pocket. If you're just rubbing your hand over your backside you shouldn't really feel it. Now if you push down, you're going to feel it."
Dr. Siegel says: "I tell patients that it's a small, pacemaker-like device that's about the size of a pocket watch. We put it in a pocket there that's about an inch or so underneath the skin. So once it's healed, if you grab that area you can feel it, but it looks smooth and you can wear tight clothing and it doesn't really protrude or it usually is not obvious. So everything's on the inside."
With Medtronic Bladder Control Therapy, can patients do everything they did before?
Dr. Noblett says: "The whole goal is to restore their quality of life and for them to do the things they want to do. For the first 6 to 8 weeks, I don't want them to do Pilates or yoga with the deep stretching – that's going to put a lot of bend on their back. Once they are healed they can get back to their routine activity. I tell them that if they are going to participate in high-impact activities – skydiving, for example – that there is a potential that the wire might migrate and need re-implantation."
Dr. Siegel says: "I tell them that once they've healed, they can go swimming, they can go dancing, they can do normal activities, and it shouldn't interfere with their day-to-day activities."
Although you should be able to do most activities you did before surgery, there are some activities which may cause discomfort or affect your implanted neurostimulator. Review the following information, and if you have any concerns or questions about these or other activities, contact your doctor.
Activities you should avoid – You should avoid activities that involve sudden, excessive, or repetitive bending, twisting, bouncing, or stretching. These movements could damage or move your implanted lead or affect the implanted neurostimulator. Examples of such activities include gymnastics, mountain biking, and any other sport or activity that involves the movements described above.
Activities you can continue – Activities that should not affect your implanted InterStim System include running, jogging, walking, road biking, swimming, sexual activity, etc.
The doctors listed on this page are paid by Medtronic as consultants. Medtronic asked for their statements regarding their experience with Medtronic Bladder Control Therapy.
Not everyone who receives Medtronic Bladder Control Therapy will receive the same results. In addition to risks related to a surgical procedure, complications associated with the InterStim System 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 such as MRI, undesirable changes in urinary or bowel function, uncomfortable stimulation (sometimes described as a jolting or shocking feeling), and others. Surgery is required to remove the InterStim System. Please refer to Important Safety Information. Always discuss the potential risks and benefits of the therapy with your physician. This therapy is not for everyone. A prescription is required.