CAPABLE Study Synopsis
Fecal incontinence is also called accidental bowel leakage. Many women experience
this very embarrassing problem which can be difficult to manage.
Doctors recommend a number of non-surgical treatments for fecal incontinence. They
include:
- Changes in diet and behaviors
- Medications: Often a large number of women with fecal incontinence will complain
of leaking only with loose or watery stools. Anti-diarrhea medications such as loperamide
(Imodium) are at times prescribed to help create more formed stools and decrease
urgent feelings of needing to go to the bathroom. Currently this medication is not
prescribed routinely for women who have only fecal incontinence although it is frequently
prescribed for women who complain of fecal incontinence and loose or watery stools.
- Pelvic muscle training exercises just as we use for other pelvic floor disorders.
The goal of the CAPABLE study is to learn more about the last two treatments: medications
and pelvic muscle training. Specifically, this study will compare the following
treatments for fecal incontinence to see if one treatment or both together are better
than usual care at improving fecal incontinence:
- Loperamide only
- Pelvic muscle training only
- Loperamide and pelvic muscle training together
- Usual care / placebo pill
Women will be randomly assigned to one of the four groups above. Treatment will
continue for 6 months. Women will report their symptoms throughout the study by
answering questionnaires and completing a bowel diary. Recruitment began in March
of 2014. The results are expected to be available in the spring of 2017.
STUDY RESULTS:
Eric Jelovsek J, Markland AD, Whitehead WE, Barber MD, Newman DK, Rogers RG, Dyer K, Visco A, Sung VW, Sutkin G, Meikle SF, Gantz MG, Pelvic Floor Disorders Network. Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods. Contemporary clinical trials. 2015 Sep; 44.
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Markland AD, Jelovsek JE, Whitehead WE, Newman DK, Andy UU, Dyer K, Harm-Ernandes I, Cichowski S, McCormick J, Rardin C, Sutkin G, Shaffer A, Meikle S, Pelvic Floor Disorders Network. Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol. Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society. 2017 Jan; 29(1).
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Jelovsek JE, Markland AD, Whitehead WE, Barber MD, Newman DK, Rogers RG, Dyer K, Visco AG, Sutkin G, Zyczynski HM, Carper B, Meikle SF, Sung VW, Gantz MG, National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial. Lancet Gastroenterol Hepatol. 2019 Sep; 4(9): 698-710.
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Richter HE, Jelovsek JE, Iyer P, Rogers RG, Meyer I, Newman DK, Bradley MS, Harm-Ernandes I, Dyer KY, Wohlrab K, Mazloomdoost D, Gantz MG, Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network and the National Institutes of Health Office of Research on Women's Health. Characteristics Associated With Clinically Important Treatment Responses in Women Undergoing Nonsurgical Therapy for Fecal Incontinence. Am. J. Gastroenterol. 2020 Jan; 115(1): 115-127.
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Read more about this study at clinicaltrials.gov.