A prospective, randomized, controlled clinical trial of placement of the artificial bowel sphincter (Acticon Neosphincter) for the control of fecal incontinence.

BACKGROUND: Severe fecal incontinence remains a disabling condition for the patient and a major therapeutic challenge for the physician. A series of observational studies have indicated that placement of an artificial bowel sphincter is associated with marked improvement of continence and quality of life. We have performed a prospective, randomized, controlled trial to evaluate the effect of placement of an artificial bowel sphincter (Acticon Neosphincter) on continence and quality of life in a group of severely incontinent adults.
METHODS: Fourteen adults (male:female, 1:13; age range, 44-75 years) were randomized to placement of the artificial bowel sphincter or to a program of supportive care and were followed for six months from operation or entry into the study. The principal outcome measure was the level of continence, measured with the Cleveland Continence Score, which provides a scale from 0 to 20, representing perfect control through to total incontinence. Secondary outcome measures were perioperative and late complications in the artificial bowel sphincter group, and the changes in quality of life in both groups.
RESULTS: In the control group, the Cleveland Continence Score was not significantly altered, with an initial value of 17.1 +/- 2.3 and a final value of 14.3 +/- 4.6 at six months. The artificial bowel sphincter group showed a highly significant improvement, changing from 19.0 +/- 1.2 before placement to 4.8 +/- 4.0 at six months after placement. One patient in the artificial bowel sphincter group had failure of healing of the perineal wound and explantation of the device (14 percent explantation rate). There were two other significant perioperative events of recurring fecal impaction initially after placement in one patient and additional suturing of the perineal wound in another. There were major improvements in the quality of life for all measures in the artificial bowel sphincter group. There was significant improvement in all eight subscales of the Medical Outcome Study Short Form-36 measures. The American Medical Systems Quality of Life score was raised from 39 +/- 6 to 83 +/- 14 and the Beck Depression Inventory showed reduction from a level of mild depression (10.8 +/- 9.3) to a normal value (6.8 +/- 8.7). No significant changes in any of the quality of life measures occurred for the control group.
CONCLUSIONS: Through a prospective, randomized trial format, we have shown that placement of an artificial bowel sphincter is safe and effective when compared with supportive care alone. Perioperative and late problems are likely to continue to occur and between 15 percent and 30 percent of patients may require permanent explantation. For the remainder, the device is easy and discrete to use, highly effective in achieving continence, and able to generate a major improvement in the quality of life.

RCT Entities:   Population Interventions Outcomes