Systematic review on the efficacy and safety of injectable bulking agents for passive faecal incontinence

Abstract

Objective: The aim of this study was to systematically review all published evidence to determine the efficacy and safety of injectable bulking agents for passive faecal incontinence (FI) in adults.

Method: Electronic searches were performed for MEDLINE, EMBASE, ISI Web of Knowledge and other relevant databases. Hand searching of relevant conference proceedings was undertaken. Studies were considered if they met the predefined inclusion criteria of more than ten adult patients and receiving an injectable bulking agent for passive FI with a validated means of assessing preoperative and postoperative incontinence.

Results: Thirteen case series studies and one randomized placebo-controlled trial (RCT) were included with a total of 420 patients. Two completed RCTs with placebo control were identified but results were unobtainable. Coaptite, Contigen, Durasphere, EVOH and PTQ injections were assessed with 24, 73, 83, 21 and 208 patients respectively. Most studies reported a statistically significant improvement in incontinence scores and quality of life. No statistically significant difference was found between the treatment and placebo arms in the RCT. No serious adverse events were reported.

Conclusions: Currently there is little evidence for the effectiveness of injectable bulking agents in managing passive FI. The inability to obtain results from two further RCTs concerned the reviewers and hindered their ability to make strong recommendations. The identified injectable bulking agents appear to be safe with only minor complications reported.