FDA Approves Botox

Q. I’m a T9 para and take Ditropan to keep my bladder quiet and my pants dry — but I hate the cotton-mouth and “fuzzy brain” side effects. I’ve seen some buzz on SCI message boards talking about “Botox injections to stop bladder spasms” being approved by the FDA. I thought docs had been using Botox to quiet bladder spasms for years — how does FDA approval change this? The post has got me thinking — how does the Botox procedure work? And is FDA approval a big deal?

—Jeff

A. Jeff, on August 24, 2011, the FDA approved Botox for treatment of spastic bladder muscle associated with neurological conditions such as SCI or MS. According to doctors I spoke with, approval for this is a big deal for several reasons: The rigorous clinical trials required for FDA approval help clarify optimum dosage; approval makes it easier for insurance reimbursement; and the mainstreaming of this bladder management option can reduce the bladder and kidney damage many people with disabilities experience.

FDA guidelines allow physicians to use a drug to treat a condition other than the one for which it was approved, and urologists have been using Botox in this “off label” manner to manage their patients’ bladder spasms for ten years. (See April 2008 Bladder Matters.) The biggest difficulty with off-label use is getting insurance plans to cover the drug and procedure. However, the practice is widespread enough that it is already covered under VA, most Medicare, and some private insurance companies (as always, check to make sure you are pre-authorized).

Dr. Victor Nitti, vice chairman of the department of urology at New York University Langone Medical Center, has been using Botox to help people with neurogenic bladders since 2001. Nitti says Botox provides an important option for people who can’t tolerate the side effects of anticholinergic medications — like Ditropan — or people who aren’t being helped by anticholinergics.

Nitti explains that while most people think about bladder spasms in terms of incontinence, staying dry and avoiding embarrassing accidents, the real danger from bladder spasms is high bladder pressure, which can cause dysreflexia, and result in damage, scaring and shrinkage of the bladder. High bladder pressure also causes reflux — urine backing into the kidneys — which causes permanent kidney damage and can lead to kidney failure. Nitti explains studies have shown that Botox injections reduce bladder pressure, increase bladder volume, and greatly increase the time before a bladder will spasm, compared to anticholinergics.

Dr. Rodney Anderson, professor of urology at Stanford University School of Medicine, has seen similar results. “[Botox] is a very convenient treatment for those that don’t respond to drugs like Ditropan, or for those that can’t tolerate the side effects,” says Anderson.

The Procedure

The FDA-approved Botox procedure itself consists of injecting 200 units of Botox into the bladder wall (much less than the 300-500 units that were generally used in off-label procedures). This is done by passing a cystoscope (a catheter with a tiny camera on the end) that has a tiny syringe on it, through the urethra into the bladder. There, a pattern of 30 injections is made on the bladder wall to block the nerve impulses and inhibit the bladder from contracting.

People that we interviewed reported their bladder was quiet immediately following the procedure. Studies used in the FDA trial showed the average length of time the bladder remained quiet, before requiring additional Botox injections, was 10 months.

Although the procedure is done on an outpatient basis, it is performed in an operating room and may require anesthesia. At minimum, an anesthesiologist should be standing by, in case of dysreflexia.

Kelly McAll, 49, from Arizona is in her 29th year as an L1 para. She has managed her bladder Ditropan and the Credé method — pressing with her hand on her abdomen to void.

“As I’ve gotten older the spasms started getting worse, and the Ditropan wasn’t working,” says McAll. “Plus the side effects were bad, my mouth was always dry, I was always tired and my vision was blurry. My bladder was constantly kicking off, I was going through five extra-absorbent pads a day, and seemed like I was always wet.”

McAll — on a small income with a $400 insurance co-pay — hadn’t been to a urologist in 15 years. “I told my urologist, ‘I’m active, I walk with a cane, I handcycle, I work, I’m a single mom, and I don’t have the time to catheterize all the time. I want to get a Mitrofanoff.’” (Mitrofanoff is a continent urinary diversion — see August 2010 Bladder Matters.) Says McAll, “My urologist wouldn’t budge and wanted me to try the Botox procedure —which I figured would be a waste of time and my $400 co-pay. But I figured I’d try it to get one step closer to a Mitrofanoff. ”

“The Botox procedure was quick, easy and I was back at work that afternoon,” she recalls. “And it was amazing! All of a sudden I was dry — I still use a pad, but at the end of a long day it is still dry!”

At press time McAll’s bladder had suddenly started spasming again. Because she voids using Credé, her urologist had a balancing act of using significantly less than the standard 200 units of Botox — trying to use just enough to quiet her bladder, yet still leave enough muscle control for the bladder to squeeze the urine out.

Since McAll has met her yearly co-pay, she says she is waiting to see what is causing her bladder to act up. If it is a UTI or bladder stones, hopefully her bladder will quiet down. She says if she needs another round of Botox, she will try it and hope the effects last 10-or-more months this time. “I’m hoping to figure things out — those three months with a quiet bladder, not having to think about my bladder, were amazing!”

Mona McAlese, 45, from Anchorage, Alaska, is in her 15th year as a T7 para.

McAlese had an extremely spastic bladder and had to catheterize every hour, and had to wake up on a regular schedule all night in order to cath. She was also suffering major side effects from Ditropan — and the Ditropan wasn’t really stopping the spasms. McAlese is also hypersensitive to any kind of indwelling Foley catheter. Three years ago she read about Botox in the New Mobility Bladder Matters column and immediately asked her urologist, Dr. Allen of Alaska Urological in Anchorage, about it. It turned out Dr. Allen was the only urologist doing the procedure in the state.

“I gave it a try and it is fantastic!” says McAlese. “It has changed my life. I had become so disciplined around finding the nearest bathroom and cathing every hour it felt weird — but great — to be able to be able to relax and not think about cathing all the time. I’m active and like to travel. Now I can go on an airline flight, or go fishing or whatever and not have to worry about a bladder accident. Plus I’m getting a full night’s sleep — not waking up every hour — for the first time in 15 years!”

McAlese says she had anesthesia during the procedure to manage dysreflexia, and the entire procedure — from wheeling in the hospital to getting back in her car — took about two hours. She says her last Botox injections kept her bladder quiet for a year, and her insurance — Blue Cross with a Medicaid buy-in — paid for it.

So if you are hoping to ditch the dry mouth and fuzzy feeling caused by Ditropan, the first step is to talk with your primary care physician, or PM&R doc and get a referral to consult with a urologist. Check with your insurance carrier, as well.

Best of luck — and let us know how it goes.

Send questions to bladder@newmobility.com.

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