Implantation of ethylene vinyl alcohol copolymer for faecal incontinence management

Jacqueline Stephens, Nicholas A. Rieger, K. Chip Farmer, Stephen W. Bell, Judy E. Hooper, Peter J. Hewett

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Purpose: 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 ≥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.

Original languageEnglish
Pages (from-to)324-330
Number of pages7
JournalANZ Journal of Surgery
Volume80
Issue number5
DOIs
Publication statusPublished - 1 May 2010
Externally publishedYes

Keywords

  • Anal sphincter
  • Ethylene vinyl alcohol copolymer (substance name)
  • Faecal incontinence
  • Phase 1 clinical trial
  • Pilot study

ASJC Scopus subject areas

  • Surgery

Cite this

Stephens, J., Rieger, N. A., Farmer, K. C., Bell, S. W., Hooper, J. E., & Hewett, P. J. (2010). Implantation of ethylene vinyl alcohol copolymer for faecal incontinence management. ANZ Journal of Surgery, 80(5), 324-330. https://doi.org/10.1111/j.1445-2197.2010.05277.x