Comparison of Quality of Life and Anorectal Function After Artificial Sphincter Implantation

Abstract

PURPOSE: Quality of life, a major outcome parameter in the treatment of anal incontinence, has not been assessed after artificial sphincter implantation. The purpose of this single-center, prospective, nonrandomized study was to assess quality-of-life differences in patients before and after artificial sphincter implantation and compare them with clinical incontinence scores and anal manometry. METHODS: Quality of life was assessed in 16 patients (14 females; mean age, 43 years) consecutively implanted with an Acticon NeosphincterTM. The Fecal Incontinence Quality of Life Scale, a quality-of-life instrument specifically designed for analysis of anal incontinence, included 27 items grouped in four domains: lifestyle, coping/behavior, depression/self-perception, and embarrassment. Fecal Incontinence Quality of Life Scale score (0 to 1, with 1 indicating better quality of life) was calculated preoperatively and postoperatively and compared with the Fecal Incontinence Score (on a scale of 0 to 120, with 120 being complete incontinence), an evacuation score, and maximal resting pressure. RESULTS: At a mean (standard deviation) of 25 (15) months,12 patients had an activated device, and 11 had satisfactory anorectal function. Significant improvement was observed postoperatively in the four separate quality-of-life domains. Mean (standard deviation) Fecal Incontinence Quality of Life Scale scores increased from 0.44 (0.14) preoperatively to 0.86 (0.18), 0.94 (0.06), and 0.83 (0.16) at 6, 12, and 24 months after implantation, respectively. For the same time periods, the mean (standard deviation) Fecal Incontinence Scores were 105 (14), 24 (26), 32 (35), and 32 (28), respectively (P< 0.05). A linear correlation was found between the improvement over time in quality of life measured by the Fecal Incontinence Quality of Life Scale and clinical evaluation of incontinence measured by the Fecal Incontinence Score (r2 = 0.97; P = 0.03). Mean (standard deviation) maximal resting pressure increased similarly from 42 (24) cm H2O preoperatively to 97 (23) cm H2O at the end of follow-up (P < 0.0001). CONCLUSION: After artificial sphincter implantation, quality of life as assessed by a new Fecal Incontinence Quality of Life Scale instrument was significantly improved. These results correlated with clinical assessment of anal incontinence and were associated with a significant increase in maximal anal resting pressure on manometry.