Figure 28.6 Acticon® Neosphincter. This device includes an inﬂatable cuff placed around the anal canal, a balloon reservoir stored behind the pubic bone, and a pump located in the labia. (Courtesy of American Medical Systems, Inc. Minnetonka, Minnesota, www.AmericanMedicalSystems.com.) the three largest case series found success rates ranging from 55% to 78% (135–137). Major infections were found in 13% to 29%, pain in 27% to 28%, and device or lead problems in 12% to 18%. More recent series containing large numbers of patients found similar results for efficacy, morbidity, and reoperation rate (138,139). High rates of disturbed evacuation also were reported.
Artificial Sphincter The artificial anal sphincter is an alternative to a graciloplasty. This is a modification of the device originally designed to treat urinary incontinence. The current device is the Acticon® Neosphincter (American Medical Systems, Minnetonka, Minnesota) (Fig. 28.6). The indications for its use are similar to those for the graciloplasty.
Implantation of the artificial anal sphincter is performed, similar to the graciloplasty, through perianal tunnels. A silastic inﬂatable cuff is placed around the native sphincter to occlude the anal canal. A pressure-regulating balloon containing radio-opaque solution is situated in the retropubic space, and a control pump is positioned in the labia majora. Activation of the control pump deﬂates the cuff, permitting defecation (Fig. 28.6).
An extensive review of the literature summarized 13 case series and one case report from 1996 to 2003. There were no randomized trials or cohort studies (140). The largest series consisted of 112 patients (141). There was one series with 53 patients, and all others had fewer than 28 patients each (142). Explantation was required in 17% to 41% of patients. Reasons for explantation included infection, erosion, device malfunction, pain, incontinence, and dissatisfaction, with infection being the most common. Surgical revision was necessary in 13% to 50% of the reports. Almost everyone had at least one adverse event, and more than one-third of these events required surgical intervention. Reasons for surgical revision were similar to those for explantation. Rates of fecal impaction ranged from 6% to 83%. All studies recorded statistically and clinically significant improvement in continence scores for patients with a functional artificial sphincter; however, most did not report the continence status for those in whom the device was explanted. The proportion of patients with a functional device ranged from 49% to 85%. The authors concluded that there is insufficient evidence on the safety and effectiveness of the artificial sphincter for fecal incontinence.
One randomized control trial of 14 patients compared an artificial sphincter with a program of supportive care (143). Supportive care included all aspects of conservative management, such as physiotherapy, dietary advice, pharmacotherapy, and advice regarding skin care, odor management, anxiety reduction, and use of incontinence aids or appliances. Significant improvements in continence scores and quality-of-life measures were seen in the artificial sphincter group but not in the control group at 6 months follow-up. Explantation rate was 14% (one of seven patients). Two other patients had complications, including severe fecal impaction and perineal wound erosion requiring reoperation. The authors conclude that the artificial sphincter is safe and effective compared with supportive care alone. They anticipate perioperative and late complications, which may require explantation in up to one-third of patients. It is also remarkable that only one patient (14%) whose condition was managed conservatively had significant improvement based on continence scores, whereas the status of all others was relatively unchanged.