Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.
Abstract
The goals of this trial are to determine the efficacy and safety of two treatments
for women experiencing fecal incontinence. First, we aim to compare the use of loperamide
to placebo and second, to compare the use of anal sphincter exercises with biofeedback
to usual care. The primary outcome is the change from baseline in the St. Mark's (Vaizey)
Score 24weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN)
trial, subjects are enrolling from eight PFDN clinical centers across the United States.
A centralized data coordinating center supervises data collection and analysis. These
two first-line treatments for fecal incontinence are being investigated simultaneously
using a two-by-two randomized factorial design: a medication intervention (loperamide
versus placebo) and a pelvic floor strength and sensory training intervention (anal
sphincter exercises with manometry-assisted biofeedback versus usual care using an
educational pamphlet). Interventionists providing the anal sphincter exercise training
with biofeedback have received standardized training and assessment. Symptom severity,
diary, standardized anorectal manometry and health-related quality of life outcomes
are assessed using validated instruments administered by researchers masked to randomized
interventions. Cost effectiveness analyses will be performed using prospectively collected
data on care costs and resource utilization. This article describes the rationale
and design of this randomized trial, focusing on specific research concepts of interest
to researchers in the field of female pelvic floor disorders and all other providers
who care for patients with fecal incontinence.
Type
Journal articleSubject
Anal sphincter exercisesFactorial design
Fecal incontinence
Loperamide
Manometry-assisted biofeedback
Randomized placebo controlled trial
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https://hdl.handle.net/10161/15137Published Version (Please cite this version)
10.1016/j.cct.2015.08.009Publication Info
Eric Jelovsek, J; Markland, Alayne D; Whitehead, William E; Barber, Matthew D; Newman,
Diane K; Rogers, Rebecca G; ... Pelvic Floor Disorders Network (2015). Controlling anal incontinence in women by performing anal exercises with biofeedback
or loperamide (CAPABLe) trial: Design and methods. Contemp Clin Trials, 44. pp. 164-174. 10.1016/j.cct.2015.08.009. Retrieved from https://hdl.handle.net/10161/15137.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Matthew Don Barber
W. Allen Addison, M.D. Distinguished Professor of Obstetrics and Gynecology
Anthony Gabriele Visco
Professor of Obstetrics and Gynecology
Robotic sacrocolpopexy, robotic hysterectomy, outcomes for surgical and non-surgical
treatments of urinary incontinence and pelvic organ prolapse, robotic surgery, mesh
erosion, Botox therapy for urge incontinence, innovation and entrepreneurship.
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