Cosimo Alex Leo ^1 2, Marjolein Leeuwenburgh ³, Alessandra Orlando ^1 2, Alison Corr ², S Mark Scott ^4 5, Jamie Murphy ¹, Charles H Knowles ^4 5, Carolynne J Vaizey ², Pasquale Giordano ⁵

Author information

• ¹Imperial College London, Kensington, London, United Kingdom.
• ²St Mark's Hospital Academic Institute, Sir Alan Park's Physiology Unit, Harrow, United Kingdom.
• ³Haaglanden Medisch Centrum, The Hague, The Netherlands.
• ⁴National Bowel Research Centre and GI Physiology Unit, Centre for Neuroscience, Surgery & Trauma, Blizard Institute, Queen Mary University of London, London, United Kingdom.
• ⁵The Royal London Hospital, Whitechapel, London, United Kingdom.

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.