How Overactive Bladder Became a Disease?>

How Overactive Bladder Became a Disease

by Jeanine Barone

Have you thought of your bladder today? If you know anatomy, it might have come to mind when you felt the need to go to the bathroom. But how often do you have a strong urge to urinate? If someone asked you, would you say something like “too often” or “a lot”? If that was your answer, though you may have thought you were healthy, you may instead be told you have a disease with the benign-sounding name “overactive bladder disorder,” or OAB.

Surprised? You shouldn’t be. You may have seen the ads on TV or in magazines showing a cartoon-like bladder—a cute one, of course, that resembles a balloon with eyes—promoting a prescription drug to treat an overactive bladder. The coining of a new disease name (and accompanying acronym) based on vague, ambiguous symptoms, and the marketing of that condition through entertaining commercials, are just two of the tactics that have resulted in the ballooning—pardon the pun—multi-billion dollar market for drugs to treat OAB.

Investigating OAB: How prevalent is it, really?

MedPage Today, a medical news service that offers continuing education credits to health professionals, together with the Milwaukee Journal Sentinel, reported the findings of an investigation into OAB in 2016. They cited a domino effect that started in the 1990s when two urologists, one from the University of Pennsylvania and the other from the University of Bristol in England, gave the condition (an excessive urge to urinate) a more “sellable” name than the range of terms that had previously been used to describe it, including urinary incontinence, unstable bladder, and detrusor (bladder muscle) instability. They also were responsible for developing the definition of the condition—which ended up broadening the potential patient population—and organizing symposia that were sponsored by the pharmaceutical industry and in which the expert speakers recommended drugs to treat the condition. A key medical journal, Urology, published a special issue in 1997 with more than a dozen papers focused on overactive bladder. It included an introduction by the same two urologists, who discussed a promising new drug, tolterodine (Detrol), which soon gained FDA approval for the treatment of OAB. The drug was manufactured by the same company (Pharmacia, which later merged with Pfizer) that had recently sponsored a conference on overactive bladder.

In 2001, the same drug company paid for an automated phone survey about bladder symptoms. The participants were asked how often they had to urinate, whether they had to visit the bathroom at night, whether they sometimes had urinary accidents, and whether they often felt urgency—that is, the need to go. Based on the results of the survey, the company estimated that 33 million adults in the U.S., mostly women, had OAB. That number grew with time as additional industry-funded surveys were conducted, reaching as high as 46 million in one survey. It found that 37 percent of people age 40 or older said they sometimes felt the symptoms of overactive bladder, and 23 percent reported that their symptoms were bothersome. But urologists at the University of Helsinki (who had no financial interest in the medication) took issue with those prevalence figures. Their own analysis in 2007 found that as few as 8 percent of adults have bothersome OAB symptoms.

Defining the symptoms and causes

The average person urinates four to eight times a day, but this depends on many factors, including your fluid intake, physical activity, age, and metabolism, as well as environmental factors such as temperature and humidity.

In 2015, the FDA published a web page for consumers, noting the short list of symptoms that typify what’s considered overactive bladder:

  • urinating too often, which means at least eight times a day or at least twice at night
  • needing to urinate immediately (that is, urgency), and
  • leakage of urine because of this urgent need to go to the bathroom.

This does not mean that everyone with urinary incontinence or other bladder symptoms has OAB. The symptoms above can stem from numerous causes, including a urinary tract infection, early pregnancy, uncontrolled diabetes, kidney stones, an enlarged prostate, or bladder cancer. Such conditions should be ruled out before a diagnosis of OAB is made. Certain medications, especially diuretics, may alsocause symptoms similar to those of overactive bladder, as can neurological disorders such as spinal cord injury, multiple sclerosis, Parkinson's disease, and stroke.

So is overactive bladder really a problem?

We've all felt an urgent need to urinate after drinking a lot (especially alcohol or coffee) or when we haven’t been able to visit the bathroom for a while. So what’s the threshold for urinary symptoms to become a disorder? What level of urinary frequency, getting up at night to urinate, or incontinence merit treatment? What about people with very mild symptoms that still fall within the definition of OAB? How important is the intensity of the urge to urinate? Is it all or nothing or on a spectrum?

In an editorial published in 2012 in the journal European Urology, Finnish researchers noted that the definition of OAB is not specific and oversimplifies numerous symptoms, implying that OAB is a disease in and of itself with a uniform treatment. The vague terms associated with OAB include this terminology (from a commonly accepted definition of the condition): “urinary urgency with or without urinary incontinence, usually with increased daytime frequency and nocturia (having to get up at night to urinate) in the absence of infection of other obvious pathology.” Notice all those vague words and phrases: “with or without,” “usually,” and “other obvious pathology.” According to these authors, for the drug companies, OAB has been “the goose that laid the golden egg.” The risk, of course, is that defining mild or infrequent symptoms as abnormal—even if they are part of the normal spectrum—results in people taking on the added expense of drugs they may not need, plus exposing themselves to a host of possible side effects.

Non-Drug Remedies for a Too-Active Bladder

Instead of immediately turning to pharmaceutical solutions for what might be deemed an overactive bladder, there are an array of lifestyle changes that may provide relief and are worth trying first.

How good are overactive bladder drugs?

There are several FDA-approved treatments for overactive bladder, including oral medications and botulinum toxin (Botox). Drugs for OAB include oxybutynin (Oxytrol) and tolterodine (Detrol), which are thought to work by inhibiting bladder contractions, as well as mirabegron (Myrbetriq), which operates by relaxing the muscles of the bladder. Oxytrol For Women is an over-the-counter oxybutynin patch that's applied on the skin every four days. (It was FDA approved in 2013. For men, only the prescription product is available.)

In a 2016 report, Consumer Reports Best Buy Drugs evaluated an array of medications typically prescribed for OAB. They found that they had limited effectiveness, with none more effective than others, though there were major price and side effect differences. In fact, though people with OAB may urinate a dozen times a day, medication may reduce it only slightly, to 9 or 10 times a day, though reactions vary. Side effects include dry mouth, confusion, constipation, urinary tract infection, sleepiness, disorientation, and heartburn. These are bothersome enough that many people (more than half) stop taking them within six months. In fact, more than 12,000 adverse effects have been reported to the FDA from OAB drugs since 2013, including almost 200 deaths and 700 hospitalizations, resulting from kidney failure, paranoid delusions, and hypertension. If you and your doctor decide to try an overactive bladder drug, Consumer Reports recommends generic extended-release oxybutynin. Though it’s more expensive than the short-acting version, taking it once a day is convenient, and it has a lower risk of side effects compared with some other drugs, according to their report.

Bottom line

Most people with bothersome bladder symptoms find relief from lifestyle changes and behavioral strategies (see inset). Consider medications as a last resort. They are expensive, have side effects (some serious), and are often not helpful.