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Perianal injectable bulking agents as treatment for faecal incontinence in adults

  • Review
  • Intervention




Faecal incontinence is a complex and distressing condition with significant medical and social implications. Injection of perianal bulking agents has been used to treat the symptoms of passive faecal incontinence. However, various different agents have been used without a standardised technique and the supposed benefit of the treatment is largely pragmatic with a limited clinical research base.


To determine the effectiveness of perianal injection of bulking agents for the treatment of faecal incontinence in adults.

Search methods

We searched the Cochrane Incontinence Group Specialised Register of trials (searched 10 June 2009), ZETOC (searched 18 July 2009), clinical trials registries (searched 18 July 2009) and the reference lists of relevant articles.

Selection criteria

All randomised or quasi-randomised controlled trials comparing use of injectable bulking agents for faecal incontinence with any alternative treatments or placebo were reviewed to evaluate the therapeutic effects. Case-control and cohort studies were also reviewed to assess risks and complications associated with the treatment.

Data collection and analysis

Two reviewers assessed the methodological quality of eligible trials and independently extracted data from included trials using a range of pre-specified outcome measures.

Main results

Four eligible randomised trials were identified with a total of 176 patients. All trials but one were at an uncertain or high risk of bias. Most trials reported a short term benefit from injections regardless of the material used as outcome measures improved over time. A silicone biomaterial (PTQ™), was shown to provide some advantages and was safer in treating faecal incontinence than carbon-coated beads (Durasphere®) in the short term. Similarly, there were short term benefits from injections delivered under ultrasound guidance compared with digital guidance. However, PTQ™ did not demonstrate obvious clinical benefit compared to control injection of normal saline. No long term evidence on outcomes was available and further conclusions were not warranted from the available data.

Authors' conclusions

A definitive conclusion cannot be drawn regarding the effectiveness of perianal injection of bulking agents for faecal incontinence due to the limited number of identified trials together with methodological weaknesses. Within the available data, however, we found no reliable evidence for effectiveness of one treatment over another in improving faecal incontinence. Larger well-designed trials with adequate numbers of subjects using reliable validated outcome measures are needed to allow definitive assessment of the treatment for both effectiveness and safety.

Plain language summary

Injection of bulking material around the anus (back passage) for the treatment of faecal incontinence in adults

Loss of bowel control, also known as faecal incontinence, can be a devastating problem. It affects men and women of all ages in up to 20% of the population. Faecal incontinence can radically affect everyday life as many people become almost house bound, being unable to undertake simple tasks, such as shopping, because they are worried about faecal leakage.

Faecal incontinence may be due to a problem with the two muscles around the anus (back passage). These muscles can be damaged or become weak due to injury during child birth or operations to treat anal conditions such as haemorrhoids (piles) and fistulas (abnormal channels between the skin and back passage). The anal muscles then become unable to hold back the stools until reaching the toilet. The inner ring or internal anal sphincter muscle keeps the anus closed at all times except when opening the bowel. A treatment has been developed to treat faecal incontinence which involves injecting a substance into or near this muscle to make it bulkier so that anus closes better. It has been advocated as a simple and safe option.

The review did not find evidence to say whether this treatment is effective or not. The four trials reviewed were of limited value because they were generally poor in methodological quality and small in size.