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Controlling Anal Incontinence in Women by Performing Anal Exercises with Biofeedback or Loperamide: A Randomized Clinical Trial
152 Pages Posted: 17 Mar 2019
More...Abstract
Background: Study objectives were to compare fecal incontinence treatments, loperamide and anal muscle exercises with biofeedback, to oral placebo and education. Combination therapy was also compared to each individual therapy.
Methods: This was a randomized factorial trial between April 2014 and April 2016. Participants were recruited from eight clinical sites in the United States. Three hundred women with at least monthly fecal incontinence were randomized to one of four groups: 1) oral placebo plus education only (n=42), 2) placebo and anorectal manometry-assisted biofeedback (n=84), 3) loperamide plus education only (n=88) and 4) loperamide and biofeedback (n=86). Participants received 2 mg/day of loperamide or oral placebo with the option of dose escalation or reduction. Women randomized to biofeedback received six visits, including strength and sensory biofeedback training. All participants received a standardized fecal incontinence patient education pamphlet and were followed 24 weeks after starting treatment. Primary analysis was intent-to-treat using general linear mixed modeling to compare changes in St. Mark's scores from baseline to 24 weeks. A -5 point change in the score was considered a minimum clinically important difference. ClinicalTrials.gov Identifier: NCT02008565.
Findings: At 24 weeks, there were no significant differences between loperamide versus oral placebo (model estimated score change, 95%CI) (-1.5 points, -3.4 - 0.4; P = 0.12), biofeedback versus education (-0.7 points, -2.6 - 1.2; P = 0.47), loperamide and biofeedback versus oral placebo and biofeedback (-1.9 points, -4.1 - 0.3; P = 0.09) or versus loperamide plus education (-1.1 points, -3.4 - 1.1; P = 0.33).
Interpretation: There were no significant differences between loperamide versus placebo, anal exercises with biofeedback versus education alone, or the combination of therapies compared to each treatment alone in improvement of fecal incontinence symptoms.
Trial Registration Number: ClinicalTrials.gov Identifier: NCT02008565.
Funding: Eunice Kennedy Shriver NICHD and the NIH Office of Research on Women's Health.
Declaration of Interest: Pelvic Floor Disorders Network Equipment was purchased at or below cost from Medspira by RTI on behalf of the PFDN in return for PFDN providing consultation on mcompass biofeedback software modifications. Medspira had no input into the design, implementation, data collection or analysis of this trial.
Ethical Approval: All sites received Institutional Review Board approval and all participants gave written informed consent.
Suggested Citation: Suggested Citation