Long-term Outcome after SphinKeeper® Surgery for Treating Fecal Incontinence—who Are Good Candidates?

PURPOSE:The efficacy of the novel SphinKeeper® procedure for the treatment of fecal incontinence (FI) is not yet well defined. This study aimed to assess long-term functional outcomes after SphinKeeper® surgery.METHODS:We included 32 patients with FI (28 female), who were operated at a tertiary referral center between August 2018 and September 2021. Functional outcome and quality of life were evaluated prospectively using validated questionnaires before and after surgery. Additionally, endoanal ultrasound and anal manometry were conducted prior and after SphinKeeper® implantation. Predictive parameters for treatment success were defined.RESULTS:The mean follow-up time was 22.62 ± 8.82 months. The St. Mark's incontinence score decreased significantly after surgery (median preoperative = 19 (IQR 17-22) versus median last follow-up = 12 (IQR 8-16), p = 0.001). Similarly, physical short-form health survey showed a significant improvement after SphinKeeper® implantation (p = 0.011). Patients with a higher degree of internal sphincter defect showed an improved objective therapy success (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 patients. Patients with a higher internal sphincter defect benefited most, whereas dislocation of the prostheses was associated with less favorable results.