Efficacy of Sphinkeeper™ implant in treating faecal incontinence

Abstract

The primary aim of this prospective study was to assess the efficacy of Sphinkeeper™ (SK) implantation in patients with faecal incontinence. Forty-two patients with faecal incontinence (14 with sphincter defects) underwent SK implantation and were followed up for a mean(s.d.) of 15·9(8·6) months. SK implantation was a safe and effective method that improved patients' quality of life. Implants and incontinence.

Figure 1

Device for Sphinkeeper™ implantation The device includes both the delivery system and dispensers in which a single prosthesis is placed; the prostheses are made of polyacrylonitrile (Hyexpan™; THD SpA, Correggio, Italy). When in a dehydrated state, they are thin and solid cylinders; 48 h after contact with body fluids, they change size, becoming shorter.

Figure 2

Target area for prosthesis placement The target area is at the level of the upper and middle thirds of the anal canal. a Adequate and b inadequate implantation.

Figure 3

Frequency of postdefaecation episodes of soiling at baseline and during follow‐up *Data collected at last follow‐up session. Frequency: never – none; rarely – less than once per month; sometimes – less than once per week to once or more per month; often – less than once per day to at least once per week; always – at least once per day. †P < 0·001 versus baseline (marginal homogeneity test).