Overactive bladder treatments multiply
12:54 am ET 05/05/2011 - MarketWatch Databased News
SAN FRANCISCO (MarketWatch) -- It may not kill you, but living with an overactive bladder can be a significant drain on your sleep and productivity, not to mention your general quality of life.
An estimated 33 million Americans suffer from the condition. The good news is people bothered by an urgent or frequent need to urinate with or without leakage have a growing variety of treatment options from which to choose, health-care professionals say. Patients for whom lifestyle changes aren't enough may find that prescription drug and neuromodulation options are more refined than they used to be.
The days when embarrassment kept people from seeking professional help appear to be on the wane.
"We're now talking about it and recognizing it is a significant problem and addressing it," said Dr. Tiffany Sotelo, director of the Pelvic Floor Center and assistant professor in the urology department at George Washington University in Washington, D.C. "There are options for many people."
Of course, overactive bladder may be a sign of other problems such as an infection, tumor or, in men, an enlarged prostate. Doctors typically look for such possible complications before making a diagnosis.
"The biggest thing is the [medical] history and the patient describing what they're experiencing," said Dr, Tomas Griebling, vice chair of the urology department at the University of Kansas in Kansas City. "That helps us to determine what type of problem they're having."
The conservative course many doctors often recommend that newly diagnosed patients try first ranges from cutting down on caffeinated and alcoholic drinks and doing bladder-retraining exercises to biofeedback and physical therapy. These techniques tend to be easiest on the pocketbook as well.
"Usually the first line of therapy is behavior modifications," Sotelo said. "I give my patients homework. I tell them to write down how much they're going to the bathroom and how much and what they're drinking."
Sometimes busy people aren't going to the bathroom enough during the day, she said, or are prone to drinking too much or too little. Kegel exercises and timed voiding, when patients train themselves to go to the restroom at certain times or intervals, can be effective tools.
"Diet modification and pelvic floor exercise or timed voiding work very well and there's no cost," Griebling said. "For some patients, that's all they need."
Others may need to try prescription drugs -- often next in line on the continuum of therapies. The number of drugs to treat overactive bladder has risen sharply in the past five years, and so have the number of advertisements promoting them to consumers.
The primary drug class is called anticholinergic or antimuscarinic. Brand names include Toviaz, Detrol, Enablex, Sanctura and Vesicare, and they can be expensive. The generic formulation called oxybutynin is the cheapest option but isn't right for some patients because side effects can include dry mouth, dry eyes, constipation and blurry vision.
Total U.S. sales of urinary-incontinence drugs were about $2.05 billion in 2010, up from $1.56 billion in 2006, according to IMS Health, a health-care information company in Norwalk, Conn. The top-selling drug last year was Pfizer's [PFE] Detrol LA, with $791 million in U.S. sales. In all, 18.5 million prescriptions were filled last year for the five top-selling drugs in the category, compared with 16.4 million prescriptions dispensed in 2006.
Consumer Reports recommends that patients with overactive bladder try lifestyle changes before moving on to drug therapy. If those don't work, it recommends Detrol and Detrol LA, the extended-release version, as best-buy drugs, meaning they give you the most cost-effective benefit with the least risk of side effects.
Most insurance plans require patients to try conservative management before pursuing more invasive or newer therapies, Sotelo said.
"Before you get into neuromodulation or Botox, you have to have failed the behavioral modifications and have failed or cannot tolerate medications."
Botox, or botulinum toxin, can be injected into the bladder lining to reduce overactive bladder symptoms for months at a time, Sotelo said, but the U.S. Food and Drug Administration has not approved it for this use.
"You're basically paralyzing or calming that portion of the bladder down," she said. "In some states, D.C, it is paid for by insurance."
Some cases of overactive bladder are associated with neurologic conditions such as multiple sclerosis, Parkinson's disease and stroke, Griebling said. But for many patients, the reason isn't known, though the mechanism for it is common.
"If you think of the bladder as it fills, the wall, which is made of muscle, should stretch, not squeeze," he said. "In some people, when the bladder is filling, the muscle is squeezing and that gives them the sense of having to rush urgently to the toilet."
The odds of having overactive bladder go up with age, though the condition can affect younger adults as well. Patients who want to do any number of sustained activities such as taking a plane trip or playing golf often resent the constant interruption, said Dave Kaysen, chief executive of Uroplasty , a medical-device company based in Minnetonka, Minn.
"If they're going to the bathroom 20 to 30 times a day, it's hard to leave the house," Kaysen said. "We've heard the term slaves to the bathroom or slaves to the toilet. They have to know where a bathroom is at all times."
Uroplasty is making a bid for patients who haven't been able to find relief after trying one or more drugs. It makes a minimally invasive neuromodulation system that targets a nerve center affecting bladder function. In Europe, it's also available to treat fecal incontinence.
Using the Urgent PC system in his or her office, a doctor inserts a small needle electrode above the patient's ankle near the tibial nerve and places a patch electrode at the base of the foot. The lead set attaches to the stimulator, which delivers electrical pulses.
"The patient feels a tingly sensation," said Kaysen, who's demonstrated the product on himself at conferences. "It feels like the foot is falling asleep. It's not unpleasant. It doesn't hurt."
"We use the tibial nerve as the highway to stimulate the sacral nerve plexus," he said.
Inconvenience may be a factor for some patients. They have to come in to the doctor's office for a total of 12 treatments once a week for about 30 minutes each. Those who need more treatments after that typically do so once a month, Kaysen said.
The product was first available in 2002 but has been redesigned, Kaysen said. "The biggest difference is the old system had a reusable lead set. The key was to develop a disposable segment of it, and that's what we did."
About 70% of Medicare patients are covered for Uroplasty's device, and Kaysen expects that figure to grow as more studies show its system is effective. Patients on Medicare have a $20 copay, so a 12-week course of treatment would run them $240. The list price is $1,500, and lead sets sell for $65 each.
Another device called the InterStim Therapy system made by Medtronic functions like a pacemaker for the bladder. It's placed under the skin of the upper buttock using local anesthesia and it's been available for more than a decade in the U.S.
An advantage to this product is patients can test-drive it on the outside for a period of time before they decide to have it implanted, Sotelo said. "You would wear a device to your belt buckle for about a week and see if it improves symptoms."
The downside is patients who decide to have InterStim can't have MRI imaging done. Since 1994, more than 85,000 people worldwide have received InterStim Therapy for bowel and bladder control, said Donna Marquard, a Medtronic spokeswoman. Most private insurers and Medicare cover it. Total outpatient costs for Medicare patients range $20,000 to $30,000.
In the future, patients with overactive bladder may be able to do neuromodulation in the home-care setting as well, said Sotelo, who's involved with a clinical trial of a needle-free neuromodulation patch made by Johnson & Johnson.
"I think there's going to be a day where they probably can get something they can do themselves that won't involve needles."
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INTERESTING LAST TWO PARAGRAPHS.
12:54 am ET 05/05/2011 - MarketWatch Databased News
SAN FRANCISCO (MarketWatch) -- It may not kill you, but living with an overactive bladder can be a significant drain on your sleep and productivity, not to mention your general quality of life.
An estimated 33 million Americans suffer from the condition. The good news is people bothered by an urgent or frequent need to urinate with or without leakage have a growing variety of treatment options from which to choose, health-care professionals say. Patients for whom lifestyle changes aren't enough may find that prescription drug and neuromodulation options are more refined than they used to be.
The days when embarrassment kept people from seeking professional help appear to be on the wane.
"We're now talking about it and recognizing it is a significant problem and addressing it," said Dr. Tiffany Sotelo, director of the Pelvic Floor Center and assistant professor in the urology department at George Washington University in Washington, D.C. "There are options for many people."
Of course, overactive bladder may be a sign of other problems such as an infection, tumor or, in men, an enlarged prostate. Doctors typically look for such possible complications before making a diagnosis.
"The biggest thing is the [medical] history and the patient describing what they're experiencing," said Dr, Tomas Griebling, vice chair of the urology department at the University of Kansas in Kansas City. "That helps us to determine what type of problem they're having."
The conservative course many doctors often recommend that newly diagnosed patients try first ranges from cutting down on caffeinated and alcoholic drinks and doing bladder-retraining exercises to biofeedback and physical therapy. These techniques tend to be easiest on the pocketbook as well.
"Usually the first line of therapy is behavior modifications," Sotelo said. "I give my patients homework. I tell them to write down how much they're going to the bathroom and how much and what they're drinking."
Sometimes busy people aren't going to the bathroom enough during the day, she said, or are prone to drinking too much or too little. Kegel exercises and timed voiding, when patients train themselves to go to the restroom at certain times or intervals, can be effective tools.
"Diet modification and pelvic floor exercise or timed voiding work very well and there's no cost," Griebling said. "For some patients, that's all they need."
Others may need to try prescription drugs -- often next in line on the continuum of therapies. The number of drugs to treat overactive bladder has risen sharply in the past five years, and so have the number of advertisements promoting them to consumers.
The primary drug class is called anticholinergic or antimuscarinic. Brand names include Toviaz, Detrol, Enablex, Sanctura and Vesicare, and they can be expensive. The generic formulation called oxybutynin is the cheapest option but isn't right for some patients because side effects can include dry mouth, dry eyes, constipation and blurry vision.
Total U.S. sales of urinary-incontinence drugs were about $2.05 billion in 2010, up from $1.56 billion in 2006, according to IMS Health, a health-care information company in Norwalk, Conn. The top-selling drug last year was Pfizer's [PFE] Detrol LA, with $791 million in U.S. sales. In all, 18.5 million prescriptions were filled last year for the five top-selling drugs in the category, compared with 16.4 million prescriptions dispensed in 2006.
Consumer Reports recommends that patients with overactive bladder try lifestyle changes before moving on to drug therapy. If those don't work, it recommends Detrol and Detrol LA, the extended-release version, as best-buy drugs, meaning they give you the most cost-effective benefit with the least risk of side effects.
Most insurance plans require patients to try conservative management before pursuing more invasive or newer therapies, Sotelo said.
"Before you get into neuromodulation or Botox, you have to have failed the behavioral modifications and have failed or cannot tolerate medications."
Botox, or botulinum toxin, can be injected into the bladder lining to reduce overactive bladder symptoms for months at a time, Sotelo said, but the U.S. Food and Drug Administration has not approved it for this use.
"You're basically paralyzing or calming that portion of the bladder down," she said. "In some states, D.C, it is paid for by insurance."
Some cases of overactive bladder are associated with neurologic conditions such as multiple sclerosis, Parkinson's disease and stroke, Griebling said. But for many patients, the reason isn't known, though the mechanism for it is common.
"If you think of the bladder as it fills, the wall, which is made of muscle, should stretch, not squeeze," he said. "In some people, when the bladder is filling, the muscle is squeezing and that gives them the sense of having to rush urgently to the toilet."
The odds of having overactive bladder go up with age, though the condition can affect younger adults as well. Patients who want to do any number of sustained activities such as taking a plane trip or playing golf often resent the constant interruption, said Dave Kaysen, chief executive of Uroplasty , a medical-device company based in Minnetonka, Minn.
"If they're going to the bathroom 20 to 30 times a day, it's hard to leave the house," Kaysen said. "We've heard the term slaves to the bathroom or slaves to the toilet. They have to know where a bathroom is at all times."
Uroplasty is making a bid for patients who haven't been able to find relief after trying one or more drugs. It makes a minimally invasive neuromodulation system that targets a nerve center affecting bladder function. In Europe, it's also available to treat fecal incontinence.
Using the Urgent PC system in his or her office, a doctor inserts a small needle electrode above the patient's ankle near the tibial nerve and places a patch electrode at the base of the foot. The lead set attaches to the stimulator, which delivers electrical pulses.
"The patient feels a tingly sensation," said Kaysen, who's demonstrated the product on himself at conferences. "It feels like the foot is falling asleep. It's not unpleasant. It doesn't hurt."
"We use the tibial nerve as the highway to stimulate the sacral nerve plexus," he said.
Inconvenience may be a factor for some patients. They have to come in to the doctor's office for a total of 12 treatments once a week for about 30 minutes each. Those who need more treatments after that typically do so once a month, Kaysen said.
The product was first available in 2002 but has been redesigned, Kaysen said. "The biggest difference is the old system had a reusable lead set. The key was to develop a disposable segment of it, and that's what we did."
About 70% of Medicare patients are covered for Uroplasty's device, and Kaysen expects that figure to grow as more studies show its system is effective. Patients on Medicare have a $20 copay, so a 12-week course of treatment would run them $240. The list price is $1,500, and lead sets sell for $65 each.
Another device called the InterStim Therapy system made by Medtronic functions like a pacemaker for the bladder. It's placed under the skin of the upper buttock using local anesthesia and it's been available for more than a decade in the U.S.
An advantage to this product is patients can test-drive it on the outside for a period of time before they decide to have it implanted, Sotelo said. "You would wear a device to your belt buckle for about a week and see if it improves symptoms."
The downside is patients who decide to have InterStim can't have MRI imaging done. Since 1994, more than 85,000 people worldwide have received InterStim Therapy for bowel and bladder control, said Donna Marquard, a Medtronic spokeswoman. Most private insurers and Medicare cover it. Total outpatient costs for Medicare patients range $20,000 to $30,000.
In the future, patients with overactive bladder may be able to do neuromodulation in the home-care setting as well, said Sotelo, who's involved with a clinical trial of a needle-free neuromodulation patch made by Johnson & Johnson.
"I think there's going to be a day where they probably can get something they can do themselves that won't involve needles."
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INTERESTING LAST TWO PARAGRAPHS.