Long-term outcome after Sphinkeeper ® surgery for treating fecal incontinence – who are good candidates?

Purpose: The long-term effect of the novel Sphinkeeper ® procedure for treatment of faecal incontinence (FI) still remains unknown. This study aimed to assess long-term functional outcomes after Sphinkeeper ® surgery. Parameters of subjective and objective treatment success and the effect of prostheses dislocation were analysed. Methods: : The study was conducted at a tertiary referral center between August 2018 and September 2021 including 32 patients with FI (28 female and 4 male). Functional outcome and quality of life were assessed using validated questionnaires before surgery, after 3, 6, 12 months and at the last follow-up appointment. Endo-anal ultrasound and anal manometry were conducted prior to Sphinkeeper® implantation and postoperatively. Results: : The mean follow-up time was 22.62 ± 8.82 months. 53.8% of patients reported having a symptom relief of at least 50% at the last follow-up. St. Mark's incontinence score decreased significantly after surgery (last follow-up visit: p=0.001). Similarly, physical Short Form health survey significantly improved after Sphinkeeper ® implantation (p=0.011). Patients with a higher degree of internal sphincter defect showed an improved objective therapy sucess (r=0.633, p=0.015) after Sphinkeeper ® operation, whereas the type and severity of FI had no impact on the functional outcome. Notably, a higher number of dislocated prostheses (r=0.772, p=0.015) showed a significant correlation with reduced improvement of incontinence. Conclusion: The Sphinkeeper ® procedure showed a significant long-term functional improvement in over half of the enrolled patients. Patients with a higher internal sphincter defect benefited most from the Sphinkeeper ® operation. Dislocation of the prostheses was associated with less favourable results.