Objective: This study evaluates the long-term morbidity, functional results and quality of life (QOL) after treatment of severe faecal incontinence (FI) with the Acticon Neosphincter (American Medical Systems, Minneapolis, Minnesota, USA).
Method: Between 1996 and 2002, 17 consecutive patients (14 female, 3 male; median age 46) underwent sphincter implantation. Clinical evaluation, incontinence severity and QOL were assessed. Anorectal manometry, endoanal ultrasound and pudendal nerve latency were performed preoperatively and at several stages of follow-up. The study was completed in December 2007.
Results: Mean follow-up was 68 months (range: 3-133). Morbidity occurred in 100% of patients from which 65% required at least one re-operation. After the first implant, 11 devices had to be removed (65%). Seven patients had a new implant. At the final stage, Acticon was activated in 9 cases (53%). Severity of FI improved from a median of 17.5 preoperatively to 9 (P = 0.005), 5.5 (P = 0.005) and 10 (P = 0.092) at 6, 12 months and at the end of follow-up, respectively. There was a significant improvement in QOL in all postoperative controls (P < 0.05). Severity of FI did not show a correlation with QOL in the preoperative period, but did at 6, 12 months and at the end of follow-up. Mean maximum resting pressure significantly increased with the full anal cuff.
Conclusion: There is a high rate of morbidity, surgical re-interventions and explants after Acticon implant. Patients should be clearly informed about this before surgery. However, patients who have not had Acticon Neosphincter explanted, experience a significant improvement in anal continence and QOL.