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The Behavioral Therapy versus Usual Care in Primiparous Women with Anal Sphincter Tears and Fecal Incontinence Study, a collaborative cohort study with 8 site locations is designed to determine the postpartum incidence of fecal incontinence (FI) symptoms in primiparous women sustaining an obstetric anal sphincter injury (OASI). The recruitment for this study was completed in June 2011, and the participants are currently in a follow-up phase.

Participants are primiparous women who had a sphincter repair at the time of a singleton vaginal delivery. PFDN Investigators and their research staff work with the Obstetrics (OB) Department at their site to approach potential participants. OB providers and resident staff are trained on how to identify and record the occurrence of an OASI for the study. Potential participants were contacted during the postpartum period and information on delivery conditions was collected by a review of medical records. At 6, 12 and 24 weeks postpartum, participants are being contacted by telephone for evaluation of FI symptoms. Symptoms of FI will be defined by at least monthly symptoms of leakage of liquid, solid stool, and mucus. These interviews are conducted by the site study coordinator and assess the presence of FI symptoms. The Fecal Incontinence Severity Index (FISI) is used at all three data collection points; whereas, the first question of the Modified Manchester Questionnaire is used at 24 weeks.

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STUDY RESULTS

Richter HE, Nager CW, Burgio KL, Whitworth R, Weidner AC, Schaffer J, Zyczynski HM, Norton P, Jelovsek JE, Meikle SF, Spino C, Gantz M, Graziano S, Brubaker L, NICHD Pelvic Floor Disorders Network. Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women. Female pelvic medicine & reconstructive surgery. 2015 Jul; 21(4): 182-9.

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ClinicalTrials.gov

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Read more about this study at clinicaltrials.gov.