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Artificial Bowel Sphincter Treats Fecal Incontinence.
SAN DIEGO -- An investigational artificial bowel sphincter provides major clinical improvement in those patients with severe fecal incontinence who can tolerate the device and its substantial morbidity, Dr. W. Douglas Wong reported at the annual meeting of the American Society of Colon and Rectal Surgeons.
But dynamic graciloplasty--another once-promising high-tech fix for intractable fecal incontinence--has come to a dead end. Its developer, Medtronic, will not pursue U.S. marketing approval, opting instead to focus on an alternative technology--sacral nerve modulation--which appears to be not only more effective and have fewer side effects than dynamic graciloplasty in severe fecal incontinence, but which also is effective in medically intractable chronic constipation.
Dr. Wong reported on 112 patients with severe fecal incontinence who received Acticon's artificial bowel sphincter in a 19-center prospective nonrandomized trial. The most common etiology was obstetric trauma, accounting for 30% of cases.
Morbidity associated with the artificial bowel sphincter consisted of 138 device-related events, necessitating surgical revision in 46% of study participants. The device had to be explanted from 31% of subjects, mainly due to infection and/or erosion.
In the 63 patients without a stoma at baseline who were able to use the artificial bowel sphincter for 1 year of follow-up, marked improvements were documented in anal incontinence and quality of life. Indeed, 55 of the 63 patients (87%) showed a greater than 24-point drop in their Fecal Incontinence Scoring System results, the predefined Food and Drug Administration standard for therapeutic success with the investigational device. On an intent-to-treat basis, however, only a modest 56% of implantations could be declared therapeutically successful, since the explantation rate was so high.
The Fecal Incontinence Scoring System is a standardized instrument having a range of 0-120, with 0 being perfect continence. The mean score among neosphincter users fell from 105 at baseline--indicative of daily ...
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- ConvaTec Launches Advanced Fecal Incontinence Management System.
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- Magazine article from: American Journal of Critical Care Padmanabhan, Anantha Stern, Mark Wishin, Judith Mangino, Mari Richey, Karen DeSane, Mary July 1, 2007 700+ words
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Source: HighBeam Research, Artificial Bowel Sphincter Treats Fecal Incontinence.