Intrarectal botox injections can halve faecal incontinence and urgency episodes in treatment-resistant patients, according to the first randomised-controlled trial to investigate the short-term efficacy of the potential new therapy.
French gastroenterologists recruited 200 adults with faecal incontinence who were considered refractory to first-line treatments and who had at least one urgency or faecal incontinence episode per week for at least three months.
The double-blind, placebo-controlled trial involved 10 injections of either intrarectal botulinum toxin type A (BoNTA, botox; Allergan) or saline (200 units in total) administered along the length of the rectum.
Findings showed that the mean number of faecal incontinence and urgency episodes per day in the BoNTA group (mean age 61, 92% female) decreased from 1·9 at baseline to 0·8 at three months after the injections based on self-reported bowel diaries.
The mean number of episodes per day for the placebo group (mean age 62, 92% female) decreased from 1·4 to 1·0 at three months.
The baseline-adjusted mean group difference at three months was −0·51.
Writing in The Lancet Gastroenterology & Hepatology [link here], the authors said a 50% or greater reduction in the number of faecal incontinence and urgency episodes per day was noted in 72% and 46% of the BoNTA and placebo groups.
Significant differences between the BoNTA and the placebo groups were also observed for delay to postpone defecation but not for daily bowel movements.
At six months, most patients in the BoNTA group reported finding the injection beneficial or useful (76% vs 43%) as well as improved quality of life (76% vs 37%), while both groups said they would ask for it again (86% vs 75%).
Coping and behaviour scores were significantly higher in the BoNTA group than in the placebo group at all visits and lifestyle scores at the three-month visit, while depression, self-perception and embarrassment scores did not significantly differ.