General Gastroenterology

by
Tara Haelle
December 22, 2023

Botulinum toxin type A (Botox) injections in the rectum reduced episodes of fecal incontinence and urgency, a randomized controlled trial showed.

Among nearly 200 patients in a modified intention-to-treat analysis, the mean number of fecal incontinence and urgency episodes per day in the Botox group decreased from 1.9 at baseline to 0.8 at 3 months after the injections compared with a decrease from 1.4 to 1.0 in the placebo group, with a baseline-adjusted mean group difference of -0.51 (95% CI -0.8 to -0.21, P=0.0008), reported Anne-Marie Leroi, PhD, of Rouen University Hospital in France, and colleagues.

Patients who received the Botox injections also reported greater improvements in quality of life and delay to postpone defecation, as well as a better general impression of the treatment, compared with patients who received the saline injection placebo, they noted in Lancet Gastroenterology and Hepatology » ….

The study appears to be the first randomized controlled trial to evaluate the potential for botulinum toxin injections to treat fecal incontinence and urgency, a condition that affects an estimated 8.3% of U.S. adults, the authors wrote. Only two previous case series and one case report have reported on these injections for fecal incontinence.

“New treatments are required for a field that has seen little meaningful therapeutic progress in 30 years and has had few adequately powered high-quality randomized controlled trials to inform its evidence base,” wrote Charles H. Knowles, MBBChir, PhD, of Queen Mary University of London, in an accompanying editorial. This trial delivered “the largest fecal incontinence treatment effect observed from any comparable sham-controlled trial,” he noted.

“Although there are some interpretive limitations resulting from the established general frailty of bowel diaries and imbalance in the primary outcome measure at baseline, this study represents an important step forward in the field, not only because it may make a new therapy available to patients, but also because it helps challenge a dogma that has consistently underplayed the importance of the rectum in the pathophysiology of fecal incontinence,” Knowles wrote.

He noted the similarities in therapeutic effect with botulinum toxin injections for overactive bladder and concluded “that [botulinum toxin type A] rectal injection therapy will rapidly gain traction with both physicians and surgeons for patients with a predominantly urge phenotype who have not responded to first-line therapies and might prefer a low-risk endoscopic treatment to trans-anal irrigation or sacral neuromodulation.”

The double-blind study included 96 patients (mean age 61.4, 92% women) who were randomly assigned to receive intrarectal injections of 200 units of Botox and 95 patients (mean age 62.1, 92% women) who received intrarectal saline injections as a placebo from November 2015 to November 2020. The participants all had at least one urgency or fecal incontinence episode per week for at least 3 months and had previously undergone conservative or surgical treatment at one of eight French specialist hospitals that did not resolve their symptoms.

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