In a generally very complete story, we only wish that full costs and known harms of the options discussed had been reported. It would have been pretty easy to include that information.
As the story explains, fecal incontinence is a problem that bothers many people and people who have it don’t like to talk about it. This review of treatment options makes clear that none is perfect. Overall, a well-done story.
The story mentions what Medicare pays for the pacemaker InterStim device and treatment.
But no cost estimate was given for Solesta. One site states: “The average wholesale price of Solesta® is $1,107 per 1 ml injection or $4,428 per treatment session.”
In order to give readers a more complete sense of the cost of alternative options, we think cost estimates should have been given for both of the newer options mentioned.
Some of the other treatment options mentioned in the story can be both effective and less expensive in appropriate patients. Cost is an important issue in this arena.
Some trial data on benefits were cited for both Solesta and InterStim.
No harms were mentioned for either of the newer brand-name approaches mentioned – the drug Solesta or the device InterStim.
The Solesta website states:
The most common risks of treatment with SOLESTA are mild pain or discomfort in the rectum or anus, (experienced by about 27 out of 100 patients) and minor bleeding or spotting from the rectum following treatment (experienced by about 16 out of 100 patients). Some patients experienced a fever (7 out of 100), abdominal pain (3 out of 100), or diarrhea or constipation (6 out of 100) after treatment.
More serious risks including infection and inflammation of the tissues in the anus may occur, but these are not common. In clinical studies, about 4 of 100 subjects experienced infection and 3 of 100 subjects experienced inflammation.
Medtronic’s InterStim website states:
The InterStim Therapy system has risks similar to any surgical procedure, including swelling, bruising, and bleeding. Complications can include pain at the implant site, new pain, infection, lead (thin wire) movement, technical or device problems, undesirable changes in urinary or bowel function, and uncomfortable stimulation. Any of these situations may require additional surgery or cause your symptoms to return.
The story explained that a sham procedure compared with Solesta had the same effect as the drug for a third of patients. An independent expert said “the results are a lot better than previous options.”
The story also cited manufacturer study data on InterStim – “40 percent reported complete continence three years after insertion of the device.”
The patient profiled – at different places in the story – said the device didn’t completely get rid of the problem, “but it makes a big difference”…and later, “It’s really quite a miracle.”
While we wish the story had included an independent critical analysis of the InterStim studies, we nonetheless feel the story conveyed the overall picture of an array of treatment options for which there is no clearcut best choice when all have limited efficacy.
The story did a good job providing background on fecal incontinence and providing NIH estimates of how many have it.
We’ll give the story the benefit of the doubt, although the end result was imperfect.
We would have liked to hear an independent expert’s evaluation of the InterStim device which, by word count, got most of the attention in the story. We only heard from a surgeon who uses it.
But at various times in the story 4 other sources were interviewed, although only one of them offered any critical analysis of the evidence.
The story provided an overview (albeit sometimes brief) of dietary changes, Kegel exercises, biofeedback, surgery to repair the sphincter, Solesta and InterStim.
Our non-journalist reviewer (HD) thought this should be graded unsatisfactory. He wrote: “While the story did a reasonable job in providing the reader with treatment options, it really centered on a Medtronic device that is only useful in certain types of patients. There are other forms of the disorder and other more effective treatment options for select patients. Readers are provided with a limited view of the disorder and its many treatments.”
The journalist reviewer (GS), while acknowledging that the discussion of treatment options was limited, still felt it was more inclusive than many such stories we review.
From the story’s discussion, it is clear that all of the options being discussed in the story are available.
Except for the discussion of the pacemaker InterStim, the story didn’t include any overt claims of novelty. And on InterStim it explained that this is a device originally approved for urinary incontinence and that it uses the same technology as a heart pacemaker.
It’s clear that the story did not rely solely or largely on a news release.