WASHINGTON – A single-use, self-administered anal insert made of soft silicone was effective and safe in reducing episodes of accidental bowel leakage, in a multi-center, prospective open-label single-arm study, Dr. Emily Lukacz reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.
The device provides a nonsurgical option for managing accidental bowel leakage (ABL), as an alternative or as an adjunct to invasive therapy, said Dr. Lukacz, professor of clinical reproductive medicine at the University of California, San Diego.
The device is designed to prevent leakage of solid and liquid stool, and is expelled with each bowel movement and subsequently replaced. The manufacturer, Renew Medical, hopes to make it available by the end of 2014 and is negotiating with the Centers for Medicare & Medicaid Services for coverage, she noted.
The study enrolled 91 people with moderate to severe bowel incontinence, who experienced at least weekly leakage of solid and/or liquid stool, with a Wexner severity score of 12 or greater (ranging from 0, fully continent, to 20, full incontinence); most were female (90%) and white (91%); their mean age was almost 69 years. Seven participants withdrew because they were not satisfied with the device.
Among the 85 participants who completed at least 1 week of treatment, the frequency of ABL dropped from eight episodes per week at baseline to one-two episodes per week at 12 weeks, an 82% reduction that was statistically significant (P less than or equal to .001), Dr. Lukacz said. Of the 85 participants, 78% experienced at least a 50% reduction in ABL frequency, and 8 (9%) achieved total continence.
The mean Wexner scores improved by about 32% after treatment, from about 16 to about 11, which was also statistically significant (P less than or equal to .001). Of the 73 who completed the full 12 weeks of the study, 57 (78%) were "very or extremely satisfied with the device," Dr. Lukacz noted.
There were no serious adverse events. The three moderate adverse events were fecal urgency, soreness, and bleeding related to the use of the insert in two participants. Almost one-quarter of the patients had episodes where the device was displaced "upward into the anal canal," but was expelled with the next bowel movement, she said.
Dr. Lukacz’s disclosures included being a paid consultant to Pfizer and Renew Medical. The study was sponsored by Renew.