The safety and efficacy of the artificial bowel sphincter for fecal incontinence: results from a multicenter cohort study.
OBJECTIVE
The aim of this trial was to evaluate the safety, efficacy, and impact on quality of life of the Acticon trade mark artificial bowel sphincter for fecal incontinence.


METHODS
A multicenter, prospective, nonrandomized clinical trial was conducted under a common protocol. Patients were evaluated with anal physiology, endoanal ultrasonography, a fecal incontinence scoring system, fecal incontinence quality of life assessment, and overall health evaluation. Patients with a fecal incontinence score of 88 or greater (scale, 1-120) were considered candidates for the study. Implanted patients underwent identical reevaluation at 6 and 12 months postimplant.


RESULTS
One hundred twelve of 115 patients (86 females) enrolled were implanted. Mean age was 49 (range, 18-81) years. A total of 384 device-related or potentially device-related adverse events were reported in 99 enrolled patients. Of these events, 246 required no intervention or only noninvasive intervention. Seventy-three revisional operations were required in 51 (46 percent) of the 112 implanted patients. Infection rate necessitating surgical revision was 25 percent. Forty-one patients (37 percent) have had their devices completely explanted, of which 7 have had successful reimplantations. In patients with a functioning neosphincter, improvement in quality of life and anal continence was documented. Mean matched fecal incontinence scores in 63 patients at 6 months follow-up was improved from 105 preimplant to 51 postimplant. In 55 patients at 12 months follow-up, mean matched fecal incontinence scores were 105 preimplant 48 postimplant. A successful outcome was achieved in 85 percent of patients with a functioning device. Intention to treat success rate was 53 percent.


CONCLUSIONS
Although morbidity and the need for revisional surgery are high, the artificial bowel sphincter can improve anal incontinence and quality of life in patients with severe fecal incontinence.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001003:Anal Canal / Q000503:physiopathology / Q000601:surgery*; D000704:Analysis of Variance; D005242:Fecal Incontinence / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D019736:Prostheses and Implants; D019919:Prosthesis Implantation; D011788:Quality of Life; D016896:Treatment Outcome