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Little difference between fecal incontinence therapies for women
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Women with fecal incontinence experience negligible differences in improvement between primary interventions including anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo, according to the results of a randomized factorial trial.
John Eric Jelovsek, MD, director of Data Science for Women’s Health in the department of obstetrics and gynecology at Duke Health, and colleagues wrote that clinicians could consider combinations of loperamide, education, oral placebo and biofeedback, but these combinations result in only slight improvements compared with individual therapies.
“In women with normal stool consistency and fecal incontinence bothersome enough to seek treatment, we were unable to find evidence against the null hypotheses that loperamide is equivalent to placebo, that anal exercises with biofeedback is equivalent to an educational pamphlet, and that loperamide and biofeedback are equivalent to oral placebo and biofeedback or loperamide plus an educational pamphlet,” they wrote.
Between April 2014 and September 2015, researchers enrolled 300 women with at least one instance of fecal incontinence per month for 3 months into the study. They randomly assigned participants into four groups: oral placebo plus anorectal manometry-assisted biofeedback, placebo plus education, loperamide plus education or loperamide plus anorectal manometry-assisted biofeedback. Patients received 2 mg per day of placebo or loperamide with optional dose escalation or reduction. The biofeedback group received six visits.
After 24 weeks, researchers found no significant difference in St. Mark’s fecal incontinence severity scores between loperamide vs. placebo, biofeedback vs. education, loperamide and biofeedback vs. placebo and biofeedback or vs. loperamide plus education.
Researchers noted that there was no difference between percentages of serious adverse events in any treatment group. Constipation was the most common event and was reported by 2% of the loperamide plus biofeedback group and 2% of the loperamide plus education group. Only one serious treatment-related adverse event was recorded: a small bowel obstruction in the placebo plus biofeedback group.
“Additional studies that account for a substantial oral placebo or education response and low treatment adherence will be needed to adequately assess these commonly used primary treatments for fecal incontinence,” the researchers wrote. – by Julia Lowndes
Disclosures: Jelovsek reports grant support from the National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Please see the full study for the other authors’ relevant financial disclosures.
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