NCT01166399

Behavioral Therapy Of Obstetric Sphincter Tears

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 362 (actual)
• Sponsor: NICHD Pelvic Floor Disorders Network · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary aim of the "BOOST Cohort Study" is to determine the incidence of FI symptoms at 6 and 12 weeks postpartum in primiparous women sustaining an OASI. Secondary aims of the cohort study are: 1. To determine the incidence rates of FI symptoms at 24 weeks post delivery in primiparous women sustaining an OASI 2. To examine the relationship between the modified WHO sphincter tear classification types and FI symptoms 3. To examine predictors (socio-demographic, physical and clinical) associated with WHO sphincter tear classifications (3a, 3b and 4) and predictors associated with FI symptoms 4. To evaluate the incidence of fecal urgency and flatal incontinence at 24 weeks postpartum in primiparous women sustaining an OASI.

Conditions

• Fecal Incontinence

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-06-01
• Completion: 2012-10-01
• First posted: 2010-07-21
• Last updated: 2020-09-10

Locations

8 sites across 1 country: United States