Implantation of ethylene vinyl alcohol copolymer for faecal incontinence management.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Stephens
Jacqueline H
JH
Colorectal Unit, Division of Surgery, The Queen Elizabeth Hospital, 218 Woodville Road, Woodville South, SA 5011, Australia.
Rieger
Nicholas A
NA
Farmer
K Chip
KC
Bell
Stephen W
SW
Hooper
Judy E
JE
Hewett
Peter J
PJ
D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000503:physiopathology; D015331:Cohort Studies; D003672:Defecation; D005240:Feasibility Studies; D005242:Fecal Incontinence / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011145:Polyvinyls / Q000008:administration & dosage / Q000627:therapeutic use*; D011788:Quality of Life; D012007:Rectum / Q000503:physiopathology; D012720:Severity of Illness Index; D016896:Treatment Outcome
D011145:Polyvinyls; C020320:ethylene-vinyl alcohol copolymer