Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.
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.
Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH, United States. Electronic address: jelovsj@ccf.org.
J
J
Eric Jelovsek
Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.
Alayne D
AD
Markland
Department of Gastroenterology, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
William E
WE
Whitehead
Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH, United States.
Matthew D
MD
Barber
Division of Urology, Department of Surgery, University of Pennsylvania, Philadelphia, PA, United States.
Diane K
DK
Newman
Departments of Obstetrics and Gynecology and Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM, United States.
Rebecca G
RG
Rogers
Department of Obstetrics and Gynecology Kaiser Permanente, San Diego, CA, United States.
Keisha
K
Dyer
Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, United States.
Anthony
A
Visco
Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, United States.
Vivian W
VW
Sung
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.
Gary
G
Sutkin
The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States.
Susan F
SF
Meikle
RTI International, Research Triangle Park, NC, United States.
Marie G
MG
Gantz
Anal sphincter exercises; Factorial design; Fecal incontinence; Loperamide; Manometry-assisted biofeedback; Randomized placebo controlled trial