Ever since the FDA expanded the approval of onabotulinumtoxin A (Botox) to include adults with overactive bladder who were not helped by anticholinergic drugs in January, David O. Sussman, DO, has been ready to educate urology colleagues on the appropriate use of the therapy, which he believes will become a common service for them to deliver.
As medical director of the Kennedy Continence Center in Stratford, N.J., and Clinical Associate Professor of Urology at the University of Medicine and Dentistry of New Jersey, Dr. Sussman was an investigator in the trials leading to the approval, and remains a consultant for Botox manufacturer Allergan, Inc.
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You recently published a study on persons given Botox for urinary incontinence (UI) due to neurogenic detrusor overactivity (Neurourology and Urodynamics. 2013;32[3]:242-249). Is this condition covered by the FDA-approved indication for Botox?
Dr. Sussman: Yes. That was the first approval—for people who had detrusor overactivity from a neurogenic cause, such as multiple sclerosis (MS), or spinal cord injury. Now, it’s approved for people who have detrusor overactivity from other causes and have failed medication. So now it’s approved for just about anybody.
Anybody with overactive bladder?
Dr. Sussman: Overactive bladder is kind of the catch-all symptom syndrome. It includes people with overactive bladder from a neurologic cause or a non-neurologic cause. The neurologic ones, which we studied first, have been the most difficult to treat, and usually fail medication. That’s where the Botox is so helpful, because it really improves the quality of life in people who, prior to this, often didn’t respond to oral medication or, if they did, [experienced] bothersome side effects. So this was great because you don’t get the typical side effects, and it’s more effective.
How did Botox come to be studied as a treatment for UI?
Dr. Sussman: I think it began with a urologist in Switzerland and a physical medicine and rehabilitation doctor in the United States. [The latter] was probably involved with spinal-cord-injured or stroke patients, who often have detrusor overactivity.
These doctors understood the mechanism of action of Botox and postulated that it might be effective in people who had these uninhibited bladder contractions. And it turns out they were right.
How long ago was this?
Dr. Sussman: I believe the first injection was probably around the late 1980s, but then it took some time. It became much more in vogue to use Botox off-label about 10 or 12 years ago. Then finally, even though it had been used off-label for such a long time, we started to do the studies to see if we could get some really good information and try to get it approved.
My expertise is in incontinence and voiding dysfunction in both males and females. So I had been involved with using Botox off-label for quite some time, and when the trials came along, we said, “This is something we should do, because we have the right patient population.”
You were an investigator on Allergan’s trials leading to the expanded indication for Botox, and you’re a consultant for the company. Do people question that as a possible conflict of interest?
Dr. Sussman: Look. Botox to the bladder is a very important tool for people who treat UI. And to be quite honest, it turns out the monetary reimbursement for Botox is really quite small. So if you’re doing it, you’re doing it because it’s the right thing for the patient, and that’s the most important thing of all. You’re doing the best thing for the patient, and it turns out it’s not a highly reimbursed procedure. It’s just good medicine.
How do you expect this approval of Botox to change the paradigm of UI treatment?
Dr. Sussman: It’s still really going to be for people who fail medications. I believe that’s still [stated] in the package insert, and I think that’s reasonable. Most people will still try oral therapy, and then once that fails, it is reasonable to consider Botox.
Before [the recent Botox approval], we did use InterStim [an implanted electrical stimulator for urinary control, described here] in both neurogenic and non-neurogenic populations. It was never really approved for the neurogenic population, but there wasn’t much else. But now, we reserve InterStim for more of the non-neurogenic population, and really use Botox for the neurogenic.
