Sphinkeeper™ for faecal incontinence: a preliminary report.

Abstract

A new artificial anal sphincter placed into the intersphincteric space, SphinKeeper™, has recently been proposed to improve outcomes in the treatment of faecal incontinence (FI). We report our preliminary results with short-term follow-up, comparing preoperative and postoperative data after implant of SphinKeeper™ in patients suffering from FI. All patients older than 18 years were included with FI of at least 6 months, incontinence episodes occurring more than once a week and resistance to other conservative treatments. Anorectal manometry, endoanal ultrasound, Cleveland Clinic FI Score, FI Quality of Life score and total number of episodes of FI per week were recorded preoperatively and at the end of the 6-month follow-up period. Thirteen consecutive patients were treated with SphinKeeper™. No intra-operative nor postoperative complications were reported. Two cases of prosthesis extrusion occurred, and in one case an anterior dislocation was detected. Maximum resting pressure, total number of episodes of FI per week and Cleveland Clinic FI Score were improved after 6 months (P < 0.05). SphinKeeper™ could be a minimally invasive procedure for FI with good postoperative outcomes. If these results are confirmed by studies with more patients and longer follow-up, it could be a first-line approach in FI.