Intrarectal Injections of BoNTA for Fecal Incontinence?

Intrarectal injections of botulinum toxin type A (BoNTA) for the treatment of fecal incontinence resulted in improvements in severity symptoms and quality-of-life scores compared with baseline, with no serious adverse events, a recent study published in The Lancet found.

“Further research will define the optimum selection criteria, dose, site of injection, re-injection frequency, and long-term results,” the authors said.

For the double-blind, placebo-controlled study, the investigators randomly assigned 200 adult patients to receive either 200 units of BoNTA (n=100) or an equivalent volume of placebo (n=100) injections. All participants had at least 1 urgency or fecal incontinence episode per week for at least 3 months and who had experienced a failure of conservative or surgical treatment.

The patients were divided into 2 groups based on their Cleveland Clinic Severity scores: less than 12, or more than or equal to 12.

The mean number of fecal incontinence and urgency episodes per day in the BoNTA group decreased from 1.9 at baseline to 0.8 at 3 months after the injections. In the placebo group, the episodes of fecal incontinence and urgency decreased from 1.4 to 1.0.

In both the groups, 40% of the participants reported constipation as their most frequent non-serious adverse event.

No serious treatment-related adverse events were reported.

Reference:
Leroi AM, Queralto M, Zerbib F et al. Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study. The Lancet. Published online: December 18, 2023. DOI: https://doi.org/10.1016/S2468-1253(23)00332-1