Rectal Botox injection improved fecal incontinence and sense of urgency.

A randomized controlled trial showed that injecting botulinum toxin type A (Botox) into the rectum reduces fecal incontinence and urinary urgency.

In a modified intention-to-treat analysis of approximately 200 patients, the average 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 post-injection. However, it decreased from 1.4 times to 1.0 times. In the placebo group, the baseline-adjusted mean between-group difference was -0.51 (95% CI -0.8 to -0.21; P=0.0008), Dr. Anne-Marie Leroy of Rouen University Hospital, France, and colleagues reported.

Patients who received Botox injections also reported significantly improved quality of life and delayed deferral of bowel movements, as well as improved overall impressions of the treatment, compared to patients who received a saline injection placebo. the researchers said. Lancet Gastroenterology and Hepatology.

The study is the first randomized controlled trial to evaluate the potential of botulinum toxin injections to treat fecal incontinence and urgency, which affects an estimated 8.3% of U.S. adults, the authors wrote. .Only the last time case series A case report describes these injections for fecal incontinence.

“New treatments are needed in a field where there have been few meaningful therapeutic advances in 30 years and few high-quality randomized controlled trials with adequate power to inform the evidence base. “Yes,” writes Queen Mary’s Dr. Charles H. Knowles MBBCir. At the University of London, accompanying editorial. The trial produced “the greatest fecal incontinence treatment effect observed in a comparable sham-controlled trial,” he noted.

“Although there are some limitations in interpretation due to the general frailty of established bowel diaries and the imbalance of primary endpoints at baseline, this study is important to improve patient access to new treatments.” “Not only does it represent an important advance in the field, but it also helps challenge dogma that has consistently underestimated the importance of the rectum in the pathophysiology of fecal incontinence.” Knowles wrote.

He noted the similarities in therapeutic effects with botulinum toxin injections for overactive bladder, and said, [botulinum toxin type A] Rectal injection therapy may be preferable to transanal irrigation or sacral neuromodulation for patients who do not respond to first-line treatment and have a predominantly impulsive phenotype who may prefer lower-risk endoscopic treatment will quickly gain attention among both physicians and surgeons. ”

This double-blind study included 96 patients (mean age 61.4 years, 92% female) who were randomly assigned to receive an intrarectal injection of 200 units of Botox or an intrarectal injection of saline as a placebo. A total of 95 patients (mean age 62.1 years, 92% female) were included. All participants had experienced at least one episode of urgency or fecal incontinence per week for at least 3 months and had previously received conservative or surgical treatment at one of eight specialized hospitals in France. I’ve had it before, but the symptoms didn’t go away.

The researchers defined an urgency episode as “the sudden need to rush to the toilet to defecate.”

To achieve statistical power, to ensure that urinary incontinence was addressed as a treatment goal, and because fecal incontinence alone may not adequately express urinary urgency, Leroi et al. A composite endpoint combining episodes was used.

“In fact, some patients have no fecal incontinence, or only a few episodes, and are unable to defer defecation, requiring strict planning of access to toilet facilities, which can limit the patient’s ability to leave the house. “This is common,” the researchers wrote.

Each patient received 10 initial injections into various submucosal sites within the rectum from a sclerotherapy needle during flexible sigmoidoscopy without the use of sedation, followed by injections to flush out any remaining fluid. I received the last injection at the first injection site. The intervention injection was 1 mL of Botox diluted in saline.

The primary endpoint was assessed using patient bowel movements diary for 21 days leading up to the 3-month follow-up appointment. At the 3-month visit, his number of fecal incontinence and urgency attacks per day had decreased by more than 50%, with 72% of patients in the Botox group versus 46% of patients in the placebo group. was approved.P=0.0001).

Treatment effects persisted after 6 months, with an average of 0.38 fewer fecal incontinence or urge episodes per day in the intervention group than in the placebo group (P=0.03). In this follow-up study, 76% of Botox patients and 43% of placebo patients found the injections beneficial or useful, and 76% and 37%, respectively, reported that the injections improved their quality of life (Pboth <0.0001). A similar proportion of patients in each group said they would seek another injection.

No serious adverse events occurred. Constipation, reported by 40% of participants in both groups, was the most common adverse event. At 6 months, patients in the placebo group can choose to receive Botox injections in an open-label extension phase.

The researchers concluded that some improvement in the placebo group was likely due to a placebo effect, stating that “positive developments in functional gastrointestinal symptoms are often observed after any therapeutic intervention, even in simulation. He said that this was due to the fact that he had