Safety, efficacy, and quality of life following Sphinkeeper™ implantation for fecal incontinence: a multicenter retrospective cohort study with mid-term follow-up

Background: Sphinkeeper (TM) (SK) implantation has emerged as a minimally invasive option for patients with fecal incontinence (FI) who fail to respond to conservative therapies. While preliminary outcomes have been encouraging, robust mid-term data remain limited. This study aimed to evaluate the safety, efficacy, and quality-of-life outcomes of SK implantation in a large, multicenter European cohort. Materials and methods: This retrospective cohort study included patients with FI who underwent SK implantation between 2017 and 2022 across seven tertiary referral centers in Europe. Eligible patients had failed pharmacological and pelvic floor rehabilitation therapies and completed at least 3 years of follow-up. Primary outcomes included changes in the Cleveland Clinic Incontinence Score (CCIS), Vaizey score, weekly incontinence and soiling episodes, and the ability to postpone defecation. Secondary outcomes assessed changes in the fecal incontinence quality of life (FIQoL) scale. All patients underwent standardized clinical, ultrasonographic, and manometric evaluations preoperatively and at 3 months postoperatively. Results: A total of 111 patients (61.2% female; median age 59.4 years) were included. Median CCIS decreased from 12 (range: 6-18) at baseline to 7 (1-10) at 12 months, with sustained improvement at 3 years (P < 0.0001). Vaizey scores and weekly incontinence episodes significantly declined, while the ability to postpone defecation improved from 8 to 18 seconds (P < 0.001). All FIQoL domains showed significant enhancement by 12 months and remained stable through 36 months. No major complications were reported, and implant positioning was confirmed as adequate in 91.9% of cases. Conclusion: SK implantation is a safe and effective treatment for refractory FI, offering durable improvements in continence, urgency control, and quality of life over a 3-year follow-up period. These findings support its role as a viable minimally invasive alternative in the contemporary management of FI.