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. 2020 Dec;22(12):2161-2169.
doi: 10.1111/codi.15277. Epub 2020 Sep 22.

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

C A Leo  1   2 , M Leeuwenburgh  3 , A Orlando  1   2 , A Corr  2 , S M Scott  4   5 , J Murphy  1 , C H Knowles  4   5 , C J Vaizey  2 , P Giordano  5
Affiliations

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

C A Leo et al. Colorectal Dis. 2020 Dec.

Abstract

Aim: The SphinKeeper™ artificial bowel sphincter implant is a 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, intra-operative and postoperative complications, symptoms [using St Mark's incontinence score (SMIS)] and radiological outcomes were analysed.

Results: Twenty-seven patients [18 women, median age 57 years (range 27-87)] underwent SphinKeeper. In 30% of the patients, the firing device jammed and not all prostheses were delivered. There were no intra-operative complications and all patients were discharged the same or the 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 the SMIS score. On postoperative imaging, a median of seven prostheses (range 0-10) were identified with a median of five (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 (χ2 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 the rate of misplaced/migrated implants. This has implications for confidence in proof of mechanism and also the need for technical refinement.

Keywords: SphinKeeper; anal incontinence; faecal incontinence; pelvic floor diseases.

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