Implantation of ethylene vinyl alcohol copolymer for faecal incontinence management

Abstract

The primary objectives of this trial were to evaluate the safety and feasibility of treatment and to gain a preliminary indication of the effectiveness of ethylene vinyl alcohol injections into the anal sphincters of faecally incontinent patients. Between April 2004 and February 2006, we conducted a prospective, single-arm, procedure optimization study of ethylene vinyl alcohol injections in 21 subjects with well-characterized faecal incontinence and an intact external anal sphincter at two Australian hospitals. There was a significant decrease in the Cleveland Clinic Florida Faecal Incontinence Score (CCFFIS) (P= 0.0005) and the Faecal Incontinence Severity Index score (P= 0.005) after treatment. At 12 months post-treatment, the mean CCFFIS had decreased by 37% (P= 0.0021), and 47% of subjects had a > or =50% improvement in CCFFIS. There were significant improvements in embarrassment (P= 0.0455) and coping/behaviour (P= 0.0056) domains of the Faecal Incontinence Quality of Life. At 12 months, the mean anal canal length had increased by 29% (P= 0.066), with 40% of patients demonstrating increases of 50% or more. There were no further improvements following retreatment. Ethylene vinyl alcohol injection into the anal intersphincteric plane is feasible and well tolerated. Improvement in faecal incontinence compared with baseline was seen. Retreating initial non-responders was not successful.