1. One year after receiving the TOPAS posterior anal sling, the majority of women experienced a 50 percent or more reduction in fecal incontinence episodes.
2. Women who received the anal sling reported significant improvement in quality of life scores.
Evidence Rating Level: 2 (Good)
Study Rundown: Fecal incontinence is an under recognized problem that impacts up to 18 percent of Americans and can have socially devastating consequences. It disproportionately affects older women, as childbirth and loss of estrogen are risk factors for weakening of the pelvic floor muscles that support the external anal sphincter. Many women don’t seek care because of embarrassment or shame, and for those who do, the options are limited. First line therapy is conservative management including dietary modifications and pelvic floor muscle strengthening like Kegels. More invasive procedures like sphincter repair, injection of bulking agents, and sacral nerve stimulation are also available but have demonstrated limited lasting success and are associated with high rates of post-operative morbidity. For urinary incontinence, also a consequence of pelvic floor muscle weakening, mesh slings have become the mainstay of treatment and work by enhancing structural support on the weakened sphincters. With this in mind, the TOPAS posterior anal sling was developed. The polypropylene mesh tape, similar in design to bladder slings, is looped posterior to the anal canal using a minimally invasive needle based delivery system. In this clinical trial, researchers at 14 hospitals around the U.S. implanted the posterior anal sling in women with refractory fecal incontinence to assess its efficacy and safety.
At one-year of follow-up, nearly 70 percent of women reported a significant reduction in the frequency of fecal incontinence episodes as well as an improvement in quality of life scores. Strengths included the high follow-up rate and stringent qualifications for treatment success. As this was a rigorous, FDA-approved trial, patients were required to meet strict inclusion criteria and may not be representative of the general population of fecal incontinence patients. Larger studies incorporating a more diverse sample of both surgeons and patients are warranted to further support the efficacy of this novel treatment.
In-Depth [prospective cohort study]: One hundred and fifty two women at 14 centers around the United States with fecal incontinence that failed conservative treatment were implanted with the TOPAS, a posterior anal sling. Fecal incontinence was assessed preoperatively and at one-year follow-up with a 14-day bowl diary, Cleveland Clinic Incontinence Scores (CCIS), and Quality of Life questionnaires. A 50 percent or more reduction in incontinence episodes was considered treatment success.
At 12 months, 69.1% of patients met criteria for treatment success and 19% reported complete continence. Median number of incontinence episodes per week decreased from 9 at baseline enrollment to 2.5 (p < 0.001). Median days per week with incontinence episodes decreased from 5 to 2.0 (p < 0.007). Mean CCIS and Quality of Life scores also improved in all domains (p < 0.001). There were no reported cases of mesh extrusion or exposure during the one-year follow-up.
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