Felicia Lane, MD, Professor at the University of California Irvine, Division Director for Female Pelvic Medicine and Reconstructive Surgery talks with Ivanhoe about an implantable device option for the treatment of the symptoms related to urinary incontinence.
What we’re talking today about, it’s a huge problem?
Dr. Lane: Yes. Urinary incontinence is very prevalent. Over 30 million women in the United States will suffer from urinary incontinence, if not more. And fecal incontinence is another type of incontinence that patients can suffer from. We have patients that will have urinary incontinence and fecal incontinence this is known as dual incontinence
And it’s something that probably goes untreated for a while because people don’t want to talk about it or admit to it?
Dr. Lane: Yeah, unfortunately patients will not voluntarily tell their provider that they have these conditions. So sometimes they’ll have to be asked before they will give that information. We’re trying different ways to get this information out to our patients so that they feel more comfortable talking to their primary providers. But a lot of times they’ll self refer to us, so they’ll look on the Internet or do their own research before they actually find a provider that specializes in the treatment of urinary and fecal incontinence.
It really affects people mentally, not just physically but mentally, it can really have an impact.
Dr. Lane: Social isolation is a big deal with patients with both urinary and fecal incontinence. There are many days that they’ll miss work because of their condition. They may not go to their children’s school events and it’s a huge cost burden for our patients. So yes, the mental impact on our patients is as important if not more so than the physical condition itself.
To start, what causes it?
Dr. Lane: There are different types of urinary incontinence; they’re not all the same. In your 40s and 50s, the most common type of urinary incontinence is called stress urinary incontinence. This is the woman that leaks urine when she laughs, coughs, or sneezes. And that can be mechanical injury, maybe from *childbirth. There are definitely some congenital factors that go into this type of incontinence. Surgery is a risk factor, but later in life the urgency incontinence is the more prominent type of urine loss that women suffer from and that’s much more complex. We don’t know exactly what causes that. Some of it can be neurologic, or sometimes it can be secondary to things like recurrent urinary tract infections. Age is the biggest predictor of that. But knowing which type of an incontinence the patient has is the most important thing we can do for them because the treatments are totally different.
And how do you treat it?
Dr. Lane: In a patient with urgency incontinence the baseline treatments are behavioral. We talk to them about their fluid intake, how to avoid bladder irritants. We call those first line therapies. And if those are not effective, then we start to march up the ladder of treatments. Second line therapies might be things like pelvic floor physical therapy, biofeedback, bladder reeducation, and then we get into medications. There are several medications in different families that are available. We have one class called the anti-cholinergics and the other class of drugs are the B-3 agonists; but they each have side effects. All medications have side effects and cost. After medications, we start to look more at procedural therapies. There is a form of percutaneous tibial nerve stimulation (PTNS). This is a type of acupuncture that we can use. Patients need to come into the office, weekly, and sometimes that can be prohibitive for a patient. Then there are implantable devices like sacral nerve stimulation and bladder Botox. The Botox is injected into the bladder muscle to reduce unwanted accidents. We discuss all these third line therapies with our patients and let them choose which is the best for them.
And so why would you use something like a stimulator?
Dr. Lane: If a patient’s failed first and second line therapies and we’re at that third line therapy, then they are candidates for sacral nerve stimulation. The patient can actually trial the system first; a temporary wire is placed along side the third sacral nerve root, and they get to go home for a week or two to see if the device is actually helping them. If it is restoring their function and they’re more than 50 percent improved, then a small battery goes under the skin so they don’t really have to think about it. It’s kind of a therapy that’s doing its job for them.
How does it work? Why does it work?
Dr. Lane: The exact mechanism of action is still not clear. The nerve signals from our bladder is modulated by this device so that our bladder can store our urine or hold our urine longer, this translates into fewer involuntary contractions of the bladder that are unwanted. It’s kind of a sensory afferent modulation. The end result is fewer accidents throughout the day and less frequent trips to the bathroom. The benefits of the Axonic’s system over the previous system that’s available is it is rechargeable so it lasts 15 years versus 4 years and patients can have MRI test if needed with the newer stimulator.
So wait, when you would have to change the battery, you’d have to do another surgery?
Dr. Lane: Correct. With the older stimulator the patient would have to come to the operating room, would have to have an incision to remove the old battery that had been at end of service, and then a new battery would be placed and that would last for approximately four and a half years.
Where is the incision?
Dr. Lane: It’s on the back; in the flank below our waist but above our buttocks. So not where we sit, and not where we bend. And the incision was about a four-centimeters with the older device and now has been reduced to 2 centimeters. So being able to have a longer life battery, one that could potentially last for up to 15 years and reduce the number of surgeries for a patient is a really huge advantage for our patients.
And that’s what this new one does. Is that the main difference or are there more differences?
Dr. Lane: Yes. The device is rechargeable, so that’s one of the main differences. It’s smaller, so it’s only about three to four CC’s, which is a third of the size of the present device. It’s rechargeable and it has conditional approval for MRI. We’ve had several patients that have had to have their devices removed in order to have an MRI because the current device is not MRI approved. This new device is now conditionally approved for MRI. So our patients can safely have an MRI with it in place so that there is no additional surgery that’s required to remove it to have an MRI.
Now this is rechargeable. How often do you recharge it?
Dr. Lane: So it varies on how much energy you’re actually using throughout the day or the week. But on average in the study patients had to charge for less than an hour once a week.
And of all your patients what percentage does it work?
Dr. Lane: Of the patients that undergo a trial at least in the study with this Axonic system, approximately 90 percent of them were responders and had a successful trial.
Any risk from this from this other than infection?
Dr. Lane: The main risk is skin infection; any time we open the skin it could cause infection. Other potential risks are pain over the stimulator site, there is the chance that the device would need to be explanted if it was not effective or if it had moved or migrated.
I mean, are you excited about this?
Dr. Lane: I’m very excited about this. I think anytime we have the opportunity to give our patients more choice we’re doing the right thing. And for a while there was only one manufacturer on the market. Now that we have multiple, I think that that will stimulate rapid progress in this area of technology. And now patients will have the choice of having a rechargeable device versus a non-rechargeable implant. I’m really excited about the technology and the potential impact it has for patients.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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