An implant that hits a nerve
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Rating
An implant that hits a nerve
Our Review Summary
Urinary incontinence is a significant health problem that is frequently unrecognized or untreated in many older adults. While the prevalence of incontinence increases with age this does not mean it is part of the normal aging process and many older adults may be unaware that it is a treatable condition. There is good quality evidence that behavior and lifestyle modification, some medications, and/or surgery can improve or resolve urinary incontinence.
In 2001, the FDA approved the InterStim sacral nerve stimulation system for the treatment of urge incontinence. Current evidence on the safety and efficacy of sacral nerve stimulation for urge incontinence appears adequate to support the use of this procedure, however patient selection is important. The diagnosis should be defined as clearly as possible and the procedure limited to patients who have not responded to conservative treatments.
The story refers to a review that found 4 randomized, controlled trials of the device. The story could have provided more detail about the strength of these studies and pointed out the limitations on the current evidence, such as the small sample sizes, limited follow up time and whether these studies were funded by the device manufacturer.
However, the story fell short in quantifying the benefits of treatment. The story provides some quantification of benefits of the device but leaves many questions unanswered. The story states that 80% of the patients experienced at least a 50% improvement in symptoms with the device. Compared to how many with conventional treatment? What does an "improvement" mean? In what symptoms? How was improvement measured?
Criteria
Satisfactory
The story mentions the cost of the device.
Not Satisfactory
The story provides some quantification of benefits of the device but leaves many questions unanswered. The story states that 80% of the patients experienced at least a 50% improvement in symptoms with the device. Compared to how many with conventional treatment? What does an "improvement" mean? In what symptoms? How was improvement measured?
Satisfactory
The story mentions re-operation due to infection and pain, mechanical failures and discomfort as harms of the implanted device.
Satisfactory
The story refers to a review that found 4 randomized, controlled trials of the device. The story could have provided more detail about the strength of these studies and pointed out the limitations on the current evidence, such as the small sample sizes, limited follow up time and the fact that many of the studies were industry sponsored.
Satisfactory
The story does not engage in disease mongering.
Satisfactory
The story quotes multiple experts. The story points out that one of the experts is a researcher on a Medtronic-sponsored trial of the device but does not mention any conflicts for the other experts, leaving the reader questioning the validity of some of their statements.
Satisfactory
The story mentions exercises, biofeedback and medications as alternatives to the device, and is careful to point out that these should be considered first-line treatment options before the device is considered. The story could have done more to describe the pros and cons of the alternatives.
Not Satisfactory
Clearly the device is available, but it is not clear how widely and how many practitioners are trained in implanting the device.
Satisfactory
The story accurately represents the novelty of the device.
Satisfactory
Because the story quoted many experts, the reader can assume the story did not rely on a press release as the sole source of information.
Total Score: 8 of 10 Satisfactory
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