Bladder matters: The incontinence implant for kids
BACKGROUND: Urinary incontinence occurs when a person is unable to control their bladder and so they also have difficulty controlling urination. Some individuals with incontinence "leak" when they sneeze or cough while other people wet themselves on a regular basis because the urge to urinate comes on so strongly and quickly they can't make it to the bathroom. Incontinence is a common problem which can be caused by a multitude of things including underlying medical conditions or physical problems. (Source: www.mayoclinic.com)
TYPES: Urinary incontinence can be categorized into a few different groups. Some types of incontinence are:
- Stress Incontinence – Stress incontinence refers to when the bladder releases a little urine when pressure, such as from a sneeze, is put on the bladder. This is often the result of an event that weakens the muscles in the bladder such as giving birth.
- Urge Incontinence – This is when the urge to urinate comes on very suddenly followed by involuntary urination. People with urge incontinence may also feel the need to urinate more often than normal.
- Overflow Incontinence – This type of incontinence is when a person is leaking small amounts of urine throughout the day. Because the bladder cannot empty completely, the remaining urine dribbles out constantly. (Source: www.mayoclinic.com)
RISKS: Certain factors can make a person more likely to experience urinary incontinence. One risk factor is sex because women have a higher risk of stress incontinence because the go through events such as pregnancy, birth, and menopause which can all cause loss of bladder control. Being overweight can also put extra pressure on the bladder and raise the risk of incontinence. More seriously, certain conditions are associated with incontinence including overactive bladder, kidney disease, or even diabetes. In addition to being embarrassing, urinary incontinence can also lead to repeated urinary tract infections and skin problems like rashes or sores. (Source: www.mayoclinic.com)
NEW TECHNOLOGY: InterStim is a device used to control urinary incontinence in people who do not have a urinary blockage and have not been able to treat their incontinence with other methods. The device is placed in the upper buttock region during a surgical procedure and it uses electrical pulses to help the communication between the sacral nerves and the brain, which are involved in bladder control. There are currently over 100,000 individuals with device and InterStim is removable if the person no longer wishes to have the device. (Source: www.medtronic.com)
John C. Pope IV, MD, Professor of Urologic Surgery and Pediatrics at the Monroe Carell Jr. Children's Hospital at Vanderbilt, discusses a new device helping children overcome urinary incontinence.
Let's talk about urinary incontinence in kids. When you think about it you might think of an older population, but it's a problem that happens in children as well; correct?
Dr. Pope: Correct.
How big of a problem is it?
Dr. Pope: It is one of the most common problems that we see in children. Urinary incontinence affects a large portion of the pediatric population, primarily from about the age of potty training until seven, eight, nine years old. It is typically more common in girls than boys but it does affect both genders.
We're not talking bed wetting at night; we're talking day time?
Dr. Pope: Correct. Bedwetting or night time wetting is a totally different problem that is considered normal even in children up to teenage years. This is a daytime problem; we should see continence during the day in most children after the age of two and a half to three.
So if it doesn't go away, what's the next step? What kinds of therapies are out there and is it medicinal or is it therapeutic?
Dr. Pope: The initial treatment is what we call conservative management, or behavioral management. One of the most common problems these kids have is they hold their urine for long periods of time and they don't ever want to go to the bathroom; they're busy playing, watching TV, and being outside. For whatever reason, they're distracted and they don't want to stop what they are doing and go to the bathroom so they just hold it indefinitely. One of the solutions that we have initially is to put them on what's called a timed voiding schedule where we have them go to the bathroom to urinate every hour and a half to two hours to make sure that they get themselves on a good schedule. A couple of other things that we try initially are to make sure they're not constipated. Constipation is one of the most common causes of urinary tract problems in these children. There are a lot of things in the diet that can also cause bladder irritation and bladder over-activity that would lead to incontinence.
If you try all these methods and they don't work, what options are left for parents and kids?
Dr. Pope: If those options don't work the next step would be to try some medications to relax the bladder. This is really a problem of bladder over-activity. So if behavioral modification, dietary modification don't solve the problem, then we're really looking at trying a medication to try and relax the bladder and slow the bladder down so that it's not causing incontinence problems
Have you had cases where neither of those options worked?
Dr. Pope: Probably ninety percent of the cases are solved by one of those two methods, either behavioral or medication. We have about ten percent of these children that we consider intractable or refactory to our standard treatment methods, and then those are the children that usually require more diagnostic testing and potential treatment.
Have they been effective? The alternative treatments for the ten percent that behavioral or medicinal didn't work on? Before this what was available?
Dr. Pope: Well before this there wasn't a whole lot available. We tried what's called biofeedback where we have a computer device, a gaming device, that we can connect to the various nerves and muscles that work the bladder and the sphincter so that they can then interact with this computer game and try to learn how to better empty or control their bladder. If that doesn't work then there really weren't any other options; we didn't really have anything else to offer them.
How has this device changed things for you and how does it work?
Dr. Pope: Well this is a device called an Interstim. It's actually been on the market for many years. Really where we got the idea was from our adult colleagues in urology who have been using this device since the late nineties for the treatment of adult refractory incontinence. The success rate there was so good we decided why don't we try this in children and see if we can have a similar success rate.
What was that success rate in adults?
Dr. Pope: It depends on the exact problem you're using it for, but seventy five to eighty percent.
So you decided, let's try this in kids.
Dr. Pope: We thought we should try this in kids. There's actually one other group in the country that has used this device and they've been doing it for several years, but it really hasn't caught on anywhere else. There's actually very little literature that talks about this in children.
What kind of prompted you to try it?
Dr. Pope: What prompted me to try it was the fact that the adult success rate has been so good and we've got this certain population of kids that are having significant problems. These are real social problems for these kids; they smell bad, they wet themselves at school, other kids make fun of them, so it's a real problem within this age group. I just wasn't happy with the fact that we didn't really have anything else to offer them so I was looking for other options and the success rate in adults was so good I thought it was worth trying in children.
How long have you been using it now?
Dr. Pope: We did our first case about a year and a half ago.
What's it been like? Let's talk about how it works and what you've seen.
Dr. Pope: It has been life changing for most of these children. We've just published our initial report on this and out of seventeen children that we have done, fifteen had significant quality of life and symptom improvement. When we looked at it statistically speaking, these children have had remarkable results. Then you ask the families and they're all glad they did it.
How do you measure the response?
Dr. Pope: We have what's called a voiding dysfunction score that we give the patients preoperatively. It basically asks questions like how often do you wet yourself, how often are you going to the bathroom, how many times a day do you go to the bathroom; those sorts of things. If you have the families, both the children and the parents, fill those out you'll see that they have a significant problem with it. Then after the device is implanted we have them repeat the voiding dysfunction test score. Most of the time anything over a score of twelve is considered abnormal, and the average score in these kids that we've done has been twenty five or greater. The post placement scores are back down to the ten to eleven range, what would be considered normal bladder function. So not only do we have the families telling us it's great, but we also have the symptom scores that reinforce that.
How does it work? How was it implanted? Was it an invasive procedure?
Dr. Pope: It's a surgical procedure that requires two stages. Bladder over-activity is the problem here nine times out of ten. What this device does is stimulate the nerves that go to the bladder to actually slow them down or inhibit their function. We know that the nerves that go to the bladder come from the lower spinal cord, or what we call the sacral spinal cord, and so the first step of the procedure is to place an electrical lead beside these nerves. We know the nerves that operate and control the bladder stem from the S3, or the third sacral nerve root, and so what we do is place a little lead alongside those S3 nerve roots. We can then test the lead to make sure it's in the right place and then once the lead is confirmed to be in the right place, we can actually use it. So step one is to put the lead in place and then have a trial to see if it works. We'll leave the trial lead in for a week or two. The families will go home, they'll give it a trial, and they'll call us back and say yeah this works great or no, this isn't working. If it is working and they decide to keep it, then stage two is where we come back and actually implant a permanent battery or generator that controls the lead. After the first trial procedure the wire actually comes out of the body and it's connected to a little box like a pager.
So there's no implant in the actual bladder?
Dr. Pope: Correct. It's all about the nerves going to the bladder.
So what does the remote do then?
Dr. Pope: Once the permanent generator is placed, everything is contained on the inside of the body. You still have to have a way to control the device, so you have what's called the controller or remote control. The generator is typically placed in the upper buttock area so to control the device you simply turn it on, hold it over the area where the generator is, and you can control it remotely. You can turn it up, down, change the settings, change the intensity, and that sort of thing.
What are you turning up and down?
Dr. Pope: You can change several things. You can change the frequency of the stimulation, you can change the power, and the higher you turn up the power the more stimulation there is. There are four or five different programs built into this and you can control which of those programs will stimulate different parts of the nerves. So all of that can be controlled, changed, and operated through the remote control device.
By controlling the device, the more stimulation means the more that the nerve is helping the bladder not evacuate?
Dr. Pope: Right. It's really sort of counterintuitive. I don't know if you've ever heard of a TENS unit, but a TENS unit is an electrical device that doctors will use to treat pain where the electrical stimulation is delivered to the nerves that are causing the pain. The electrical stimulation over-stimulates the nerve which makes the nerve shut down, so it's the same concept here; we're over stimulating the nerve in order to make it shut down. The intensity of the device can be turned up or down and we basically turn it up as high as we need to get a response from the patient. If we have it set at one point five intensity, for example, and they're still having trouble with incontinence, we can increase the power or the intensity going to the nerve.
Have there been any negative side effects?
Dr. Pope: The most common side effect with this procedure is lead breakage. The lead will become dislodged or it will break. I had one little girl who was playing softball and took a rough hit sliding into home plate and it dislodged her lead. We had to go back and replace it. We had another little boy who got into an altercation on the playground and somehow fell off a jungle gym and dislocated his lead, but that's the most common negative complication if you will. Usually anytime you have an artificial device implanted into the body you can get an infection, but those are sort of the main risks.
Is this a lifelong device or will they eventually grow out of that daytime incontinence?
Dr. Pope: Well, it's a little too early to know. That's why we've started work to study these kids from a time before we put the device in. In adults it's typically a lifelong issue, although some of them can have their symptoms resolve. In those patients we can sometimes turn the device off and if they don't need it anymore they can have it removed. That's my hope in children that as their bodies mature you can turn off the Interstim and ultimately take them out, but at this point in time it's simply not known in kids.
It's not FDA approved yet for kids so it's being used off label. Are you hoping it's FDA approved at some point? Is your study concluded?
Dr. Pope: No, our study is ongoing. We've had it in one boy for about two years now and he's doing great with it. At some point we'll try to turn it down or turn it off and see how he does without the stimulation. I doubt it will ever be FDA approved in children because the demand is simply not high enough to warrant the very cumbersome and long process required for FDA approval.
Does it need to be?
Dr. Pope: No, I don't think it needs to be. I explain to all the families that it isn't FDA approved in children but that the risks and benefits are the same as they are in adults. The down side is the risk profile, that we have already mentioned, and it's the same in children and adults.
Can we talk about Ashley's daughter? How bad was her situation?
Dr. Pope: She was sort of the classic case of refractory urinary incontinence despite behavioral, dietary and medicinal treatment. When the kids fail that, typically our next step is to do what's called an urodynamic evaluation where we actually look at the function of the bladder as it fills and empties. In her case it was very clear that as the bladder filled she began having abnormal involuntary contractions that she couldn't control. Those contractions ultimately became strong enough that it caused her to leak. So she had to take two or three pairs of clothes to school every day, she couldn't go to friends' houses, and it was a very traumatic experience for her because of her bladder over-activity. Nothing we had before would help take care of her problem so I offered the Interstim. We were still fairly early in our trial and the beauty of doing this is you put the temporary lead in and give them a trial so you'll know pretty quickly whether it's going to help or not. If it doesn't help, it just slips right out. If it does work, then you can go back and make it a more permanent thing. Of our seventeen patients we have not had a single one say no, we don't want it. All seventeen have said, "Wow this has helped enough that we want to go on and have it (the generator) permanently implanted."
I talked to Ashley and she mentioned not having to bring clothes to school. She has more of a normalcy now; correct?
Dr. Pope: Right. I think that's what all the kids will say. It's still not perfect but based on where they were and where they are now, they've all said, "We're so glad we did this; it's changed our lives and helped immensely."
How does it make you feel to give them that help?
Dr. Pope: I'm just glad we have another option for these kids. Being a father myself, I know how traumatic it is if your child is having a problem. If you seek help for that problem and are basically told there's not anything else we can do, then that's frustrating for the family and for me as a physician. So, I think it's great that we now have something else we can at least offer them rather than just say sorry there's nothing else we can do.
Do you think your study will maybe encourage other doctors to try this on their pediatric patients?
Dr. Pope: There is one group in Minnesota that's been doing this for years, it's just never really caught on. It only really applies to about ten percent of this total incontinence population, and so what I don't want to happen is for people to say, "Okay, we'll just start putting it in everybody." It's got to be the select patient that has failed everything else, but in that population it's been great and I hope others will see that.
You can explain it again, but they put it in for a trial period?
Dr. Pope: The trial that's for a week or two actually has the lead coming out of the body.
We've seen other devices like that.
Dr. Pope: Right, and it's hooked up to the battery pack and this is actually the permanent generator, which you can see if fairly small.
Do you have any advice for parents who are dealing with this situation and they maybe haven't gotten to this point yet but are having to deal with embarrassing situations? Do they come to you asking how do I deal with this if it happens in public or how do I help my kid?
Dr. Pope: Urinary incontinence in children is a very common problem. I think the mainstay of treatment is what we call timed voiding where they're actually going to the bathroom on a timed schedule, making sure they don't have any constipation problems, and watching what they eat and drink. If the general public can be educated on those types of things, then I think that most of these problems would take care of themselves.
Would that be the behavioral and medicinal?
Dr. Pope: Behavioral and dietary; don't discount dietary. There are a number of things, especially in the modern child's diet, that cause significant bladder irritation and can lead to these problems of incontinence. The big players are caffeine, carbonated beverages, citrus juices, and milk products believe it or not. Kids need three to four servings of milk in their diet for their bone health, but if you start adding up how many servings of milk products modern kids have it's really astounding because you have to count milk in a glass, milk on your cereal, cheese, yogurt, ice cream, cottage cheese, all those things. I've had some kids that are having twenty five, thirty milk servings a day and that are driving your bladder crazy.
FOR MORE INFORMATION, PLEASE CONTACT:
John C. Pope IV, MD
Professor, Urologic Surgery and Pediatrics
Monroe Carell Jr. Children's Hospital at Vanderbilt
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