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