This news story covers a clinical trial that compared two different treatments for severe urinary urge incontinence in women. One treatment, which is more standard, is an electrical stimulator that calms nerves. The other and less well-understood treatment is shots of Botox (also known by its scientific name, onabotulinumtoxinA) to the same nerves.
The story doesn’t go over-the-top in its characterization of how Botox shots for incontinence could help people, and especially women (who disproportionately deal with the problem). It also hedges the benefits well and discusses the primary potential harm of Botox injections for severe incontinence. However, the story missed some of the nuances about the study’s findings (such as the researchers’ conclusions that the results are of “uncertain clinical importance”). It also attempts to discuss cost, but provides no prices, and doesn’t go far enough in detailing the potential harms of either treatment. And, because the story’s only interviewed source has potential conflicts of interest, independent scrutiny was needed.
Urinary incontinence is common, affecting millions of individuals, both women and men. The prevalence increases with age, but it is not a normal result of aging. The condition is more prevalent in women, though beyond the age of 80, both men and women reportedly have similar rates. The kind of incontinence studied here–“severe refractory urge incontinence”–specifically means a person has an abnormally frequent urge to urinate, and it is resistant to standard treatments.
We hear a lot about costs throughout this story, but see no specific numbers or meaningful discussion. And this is a major oversight, since—at least according to a 2015 study that focused on the UK National Health Service—Botox combined with quality supportive care “appears to be a cost-effective use of resources.”
A neurostimulator for bladder issues costs between $20,000 and $30,000. Meanwhile, one unit (or “U”) of Botox costs roughly $10-$28, with a typical cost hovering between $10-$12 per U. Since the treatment uses 200 U of Botox, its price is likely about $2,000-$2,500 per 6-month treatment course, but that doesn’t include the cost of administering it, which is likely to be considerable.
The benefits are stated as such:
The Botox injections freed 20 percent of the women in the study of incontinence, compared to 4 percent who had a nerve stimulator implant, Amundesen and colleagues reported in the Journal of the American Medical Association.
“Forty-six percent in the onabotulinumtoxinA (Botox) group and 26 percent in the sacral neuromodulation group had at least a 75 percent reduction in the number of episodes of urgency incontinence,” they added.
and
On average, both treatments cut the number of “accidents” – Botox by almost four times a day and the nerve stimulator by about three times a day.
This is sufficient for a Satisfactory rating on this criterion. We would have liked to have seen more discussion about actual improvements (perceived and otherwise) to patient quality of life. The closing line of the study brings this into question, i.e. how the work is of “uncertain clinical importance,” and good interview questions with both a study author and independent expert source could have greatly clarified the issue.
Urinary tract infections were three times more common in the women who received Botox shots, and the reader is informed of this. But a lot is left out. We would have also liked to see noted other side effects of Botox for urinary incontinence, such as blood in the urine, fatigue, insomnia, and inability to completely empty the bladder (in about 17% of people) — and the need to self-catheterize to relieve the problem.
And then there are the more general side effects left out of the story, including “dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes,” according to botoxforincontinence.com. And what of the harms of a neurostimulator implant? There’s no mention of this, and the side effects are numerous.
The story does a decent job of explaining that the study, stating it was “a head to head comparison of a single Botox injection to the implanted medical device, assigning 381 women to randomly get one or the other treatment. The women were asked to keep diaries for six months.” We’re also told that the women had to have about 6 accidents over three days to be included in the study, and that other more standard treatments didn’t help.
The headline is also accurate, in terms of what the study found, and it doesn’t overplay the results. In looking at the study, however, we’ll note how we were struck by two things. First, the patients’ reported impression of improvement in bladder leakage and function failed to pass a test of statistical significance, which undermines the story’s claim that “both groups of women reported equal satisfaction.” Second, the closing lines of the study point out how the treatment “resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance.” This should have been explained to readers, along with details on what this means when researchers draw this conclusion.
We don’t see any language that would unnecessarily frighten a reader. The condition is real, uncomfortable, and carries significant impact on people’s daily lives.
We didn’t see any backstopping of this study by an outside source. Although nonprofit websites are quoted, that material is used for purposes of background — not to assess the study’s claims. Another significant oversight here is no mention of co-authors’ financial relationships with the products used in both arms of the trial. (We give props to a Duke University press release about the study for pointing this out.)
A quick Google search of the lead author’s name and the term Medtronic reveals that she has been a consultant for the neurostimulator devicemaker, as well as for Allergan, Botox’s manufacturer.
We not only see a comparison to the medical device that the study focused on, but also methods that require no overt treatment, “such as weight loss, drinking less caffeine and alcohol, and avoiding lifting heavy objects.” The story also notes that “[e]xercises to strengthen the pelvic floor muscles can help, as can ‘bladder training’ to accustom the body to urinating at regular times.”
The story could have been more clear that these treatments aren’t likely to work for the women in this study who had a specific type of severe urge incontinence that is usually not responsive to exercise and other less invasive measures.
Both of these treatments are widely available. But, a description of the procedures themselves would have been helpful (they are both quite invasive and require seeing providers with special training). While ‘regular’ Botox cosmetic treatments can be easily given by various medical professionals, without specialized training, in the office, this may not be the case for Botox injections into the bladder.
The story didn’t establish what’s novel about this study. As the news release states, the study was “the first randomized trial comparing the efficacy of two FDA-approved, third-line therapies in a severely affected population.”
We didn’t catch any overtly copy/pasted quotes or language that made its way into the story from the Duke University news release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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