Efficacy of botulinum toxin type A (BoNTA) injections for the treatment of faecal incontinence

A recent study suggests that intrarectal botulinum toxin type A (BoNTA) injections are an efficacious treatment for urge faecal incontinence. This study was published in the journal, The Lancet. Gastroenterology & Hepatology.

This phase 3 study was a double-blind, multicentre, randomized trial that included 200 adult patients who had experienced a failure of conservative or surgical treatment or had at least one urgency or faecal incontinence episode per week for a minimum of 3 months. After withdrawals, the patients were randomly assigned in a 1:1 ratio to receive either 200 units of BoNTA (n=96) or an equivalent volume of saline or placebo (n=95) injections. Three months after treatment, the number of episodes of faecal incontinence and urgency recorded in 21-day patient bowel diaries served as the primary endpoint. For the primary analysis, a modified intention-to-treat (mITT) approach was utilized, with adjustment for baseline faecal incontinence and urgency episodes.

At the end of the study, it was observed that in the BoNTA group, the mean number of faecal incontinence and urgency episodes per day, decreased from 1·9 at baseline to 0.8 at 3 months after the injections were administered while in the placebo group, it decreased from 1.4 to 1.0. The trial did not report any serious treatment-related adverse events. The non-serious adverse event (treatment-related or not) that was frequently seen was constipation, seen in 68 patients in the BoNTA group and 38 patients in the placebo group. From the above results, it can be concluded that BoNTA injections are an efficacious treatment for urge faecal incontinence in adult patients.