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Behavioral Therapy Of Obstetric Sphincter Tears


BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study




The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12 and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks postpartum, subjects will be 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. Flatal incontinence will be assessed at 24 weeks, based on the Fecal Incontinence Severity Index, and fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire. A sample size of approximately 400-450 subjects will be enrolled.

Study Status: Completed


Condition Intervention Phase
Fecal Incontinence n/a Phase 3

Verified by NICHD Pelvic Floor Disorders Network September, 2013

Sponsored by: NICHD Pelvic Floor Disorders Network
Information provided by: NICHD Pelvic Floor Disorders Network identifier: NCT01166399

Study Type: Interventional

Study Design: Observational Model: Cohort, Time Perspective: Prospective

Cleveland Clinic
Cleveland, Ohio 44195
United States

Holly E Richter, PhD, MD., Study Chair

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