Abstract
The Sphinkeeper(®) procedure for treating faecal incontinence (FI) may be associated with potential implant migration (IM) and dislocation (ID), with considerable variations regarding their occurrence and effects on consecutive functional outcome. This study assessed IM and ID following the Sphinkeeper(®) procedure and its correlation with physical activity. This was a prospective observational clinical study of ten patients undergoing Sphinkeeper(®) operation due to FI between August 2020 and November 2020 at the Medical University of Vienna. Patients were followed-up after 1, 2, 3 and 6 months and 1 year postoperatively. Each follow-up visit included endosonographic monitoring of protheses location and manometric examinations. Additionally, functional outcome and physical activity were assessed using validated standardized questionnaires. The median number of prostheses implanted was 10 (IQR 9-10). The St. Mark's incontinence (SMS) score improved significantly until the last follow-up (p = 0.049), without observing a significant effect on the physical SF-12 score. The median rate of implants leading to IM and ID was 3 (range 1-4) and 2 (range 1-2) after 3 months of follow-up. A strong association of deltaSMS with number of dislocated prostheses at one month after Sphinkeeper(®) implantation was observed (r = 0.654, p = 0.078). Physical activity, assessed by the international physical activity questionnaire, did not have an impact on the correct prosthesis placement (1 month: p = 0.527; 2 months: p = 0.886; 3 months: p = 0.180; 6 months: p = 0.111). IM and ID of Sphinkeeper(®) prostheses occurred frequently early after surgery and affected functional outcome negatively. Physical activity did not have an influence on the implants displacement.