This story is about a proposed new drug for nocturia, which is defined as having to urinate two or more times during a normal night of sleep. The story also briefly mentions another study linking increased physical activity with a smaller number of people suffering from nocturia.
The story included commentary from an independent source and discussed potential harms of the drug, which is good. And we’re told early on that the information about the study will be used a a presentation at a conference, making it preliminary. We also appreciated that the study’s funder was disclosed.
But the story didn’t mention potential pricing for this new drug, and it didn’t compare the drug against currently available treatments for this condition.
Older adults often make more trips to urinate during the night. This is especially true of men with prostate problems, and this can dramatically interrupt sleep. A safe, effective treatment for this problem would be beneficial for severe sufferers–if it’s an improvement over current options.
The price or potential price of this drug is not discussed. Since there is mention of the drug already being “commonly” used in children, we assume there’s some idea of how much it costs–though it’s not made clear.
We’re giving the benefit of the doubt on the rating, though we wish the story were more precise. The story says the results showed “a significant decrease,” and the average was “two fewer episodes” per night, but a reduction from how many episodes total is unclear. The same lack of details complicate the discussion of the measured increase in uninterrupted sleep and quality of life. The numbers in the story, though a little vague, at least give some sense of the magnitude of the benefit in terms that are meaningful to people with this condition.
The story includes risks of using this drug in the elderly, and mentions that it is already on a list of drugs not to be given to the elderly. The story also discusses incidences of low blood sodium levels that sometimes occur with this drug.
This was a tough one to rate because the study hasn’t actually been published, which means it hasn’t received peer review. However, there are enough details about the study that we feel it rates as a Satisfactory explanation of the quality of evidence.
For example, fairly early on, we’re told the study was presented at a urology conference, and at the very end of the story do we learn this means the results are considered “preliminary,” an important indicator of the study’s quality. Other details in the story that help the reader assess the quality of the evidence is the specific number of people in the trial (1,400), and that it was randomized to either placebo or not. While no study limitations are pointed out, an independent source does stress the need for additional research, and the story states the drug is considered not approved for use in this way and is “investigational.”
One area that confused us was the timeframe of the intervention–the story says the study was three months long, but that participants only kept diaries for three days. Longer study durations generally indicate stronger evidence, so this ideally would be clearer.
Nocturia can impact quality of life, and increase the risk of falls among older adults, which can be devastating. So this story doesn’t disease monger, but we wished it had made the point that the majority of people getting up twice a night (very mild nocturia) likely do not need to take a medication and are not suffering from terribly disturbed sleep nor have an increased risk of falling.
An outside source was used in this story. We’re also told that the was paid for by the drug company.
No other treatments for nocturia are mentioned in the story, although it says there are no drugs approved for its treatment. However, there are a number of behavioral approaches to treating nocturia that are not considered at all in this story, except for a passing reference to another paper on exercise.
The story makes it clear that it’s not FDA approved yet.
The story does say that this is the first drug under consideration for treatment of nocturia, which would make it novel, however, there are already drugs available for treatment of frequent urination, although not only for nighttime use.
The story does not appear to rely on a news release.