Initial experience with SphinKeeper™ intersphincteric implants for faecal incontinence in the United Kingdom: a two-centre retrospective clinical audit

Abstract

Aim

The SphinKeeper™ artificial bowel sphincter implant is relatively new surgical technique for the treatment of refractory faecal incontinence. This study presents the first experience in two UK tertiary centres.

Method

This is a retrospective audit of prospectively collected clinical data in relation to technique, safety, feasibility and short-term effectiveness from patients undergoing surgery from January 2016 to April 2019. Baseline data, intraoperative and postoperative complications, symptoms (using St Mark’s incontinence score [SMIS]) and radiological outcomes were analysed.

Results

Twenty-seven patients (18 female, median age 57 [range 27-87]) underwent SphinKeeper. In 30% of the patients, the firing device jammed and not all prostheses were delivered. There were no intraoperative complications and all patients were discharged the same or following day. SMIS significantly improved from baseline (median -6 points [range -12 to +3]; p < 0.00016) with 14/27 (51.9%) patients achieving a 50% reduction in SMIS score. On postoperative imaging, a median of 7 prostheses (range 0 – 10) were identified with a median of 5 (range 0 – 10) optimally placed. There was no relationship between number of well-sited prostheses on postoperative imaging and categorical success based on 50% reduction in SMIS (Chi2 test: p = 0.79).

Conclusion

SphinKeeper appears to be a safe procedure for faecal incontinence. Overall, about 50% patients achieved a meaningful improvement in symptoms. However, clinical benefit was unrelated to rate of misplaced / migrated implants. This has implications for confidence in proof of mechanism and also the need for technical refinement.

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