The Use of Sphinkeeper® In Faecal Incontinence

Abstract

Introduction: Faecal Incontinence is a condition that can affect up to 20% of population during their lifetime with female predominance. Sacral Nerve Stimulation (SNS) has been recently shown to have significant benefits in mainly urge incontinence but this has left a large group of patients with passive incontinence without effective management options. The SphinKeeper® (SK) allows treatment of more sizeable defects in the internal or external anal sphincter. Preliminary series have shown some benefit of the procedure in treatment of faecal incontinence. Methods: A single-centre retrospective observational study of SphinKeeper® prostheses was conducted at St Helens and Knowsley NHS trust and we believe this to be one of the largest series of SphinKeeper® in the UK. SphinKeeper® restores sphincter function by using placement of self-expanding prostheses into the inter-sphincteric space. The operation involves implantation of 10 self-expanding sterile prostheses between the internal and the external sphincter, thus creating a third ring around the circumference of the anal canal. Results: Most patients were ASA 2 (n=10). 43% (6/14) patients had previous colorectal surgery – THD and mucopexy (n=3), anorectal fistula surgery (n=1), anterior resection of rectum (n=1) and pelvic floor repair (n=1). EUS was carried out in 6 patients and in all 6 cases identified internal or external anal sphincter defect (IAS n=1, EAS n=3, IAS and EAS n=2). No patient sustained intraoperative complications. 2 patients reattended within 48 hours post op due to severe post-operative pain and were discharged with analgesia. Subjective results were evaluated using Vaizey and Wexner scores and showed significant improvement 4/14 patients, partial improvement in 7/14 patients and no improvement in 3/14 patients. Discussion: Our study evaluated the short-term outcomes of the procedure in 14 patients who had SphinKeeper® surgery between May 2017 and August 2020. Patients who took part in our study had previous treatment for faecal incontinence by a variety of methods (both medical and surgical) and suffered from different types of FI (passive, urge, mixed, associated urinary incontinence). It was promising to see there was a clinically significant improvement in continence indicated by a decrease in Vaizey and Wexner scores (p=0.00377 and p=0.00334 respectively (Wilcoxon test)) with 11 patients improving in scores. It is reasonable to consider Sphinkeeper™ as a safe and minimally invasive surgical intervention to achieve some degree of positive improvement for patients suffering from faecal incontinence.