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Behavioral Therapy Of Obstetric Sphincter Tears

Study:

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

Rationale:

n/a

Purpose:

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

Recruiting:
n/a

Condition Intervention Phase
Fecal Incontinence n/a Phase 3

Verified by Susan Meikle, MD MSPH January, 2013

Sponsored by: Susan Meikle, MD MSPH
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.