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An implant that hits a nerve

Rating

4 Star

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

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story mentions the cost of the device.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

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?

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The story mentions re-operation due to infection and pain, mechanical failures and discomfort as harms of the implanted device.

Does the story seem to grasp the quality of the evidence?

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.

Does the story commit disease-mongering?

Satisfactory

The story does not engage in disease mongering.

Does the story use independent sources and identify conflicts of interest?

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.

Does the story compare the new approach with existing alternatives?

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.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Clearly the device is available, but it is not clear how widely and how many practitioners are trained in implanting the device.

Does the story establish the true novelty of the approach?

Satisfactory

The story accurately represents the novelty of the device.

Does the story appear to rely solely or largely on a news release?

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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