Behavioral Therapy Of Obstetric Sphincter Tears (BOOST)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study|
- Incidence of FI [ Time Frame: 6 and 12 months postpartum ] [ Designated as safety issue: No ]The primary aim for this study is to determine the incidence of FI symptoms (based on the FISI)at 6 and 12 weeks postpartum in primiparous women sustaining an OASI.
- Incidence of FI [ Time Frame: 24 weeks postpartum ] [ Designated as safety issue: No ]A secondary aim for this study is to determine the incidence of FI symptoms (based on the FISI) at 24 weeks postpartum in primiparous women sustaining an OASI.
- Fecal urgency [ Time Frame: 24 weeks postpartum ] [ Designated as safety issue: No ]Fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire
|Study Start Date:||July 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Primiparous women with an obstetric anal sphincter tear
Subjects in this trial will be primiparous women who underwent anal sphincter repair at the time of a singleton vaginal delivery. Sphincter tears will be clinically characterized at the time of delivery as <50% tear through the anal sphincter (modified WHO 3a), >50% (modified WHO 3b), or complete tear through the anal sphincter (4th degree). Subjects in this study will not have receive study interventions.
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:
- To determine the incidence rates of FI symptoms at 24 weeks post delivery in primiparous women sustaining an OASI
- To examine the relationship between the modified WHO sphincter tear classification types and FI symptoms
- To examine predictors (socio-demographic, physical and clinical) associated with WHO sphincter tear classifications (3a, 3b and 4) and predictors associated with FI symptoms
- To evaluate the incidence of fecal urgency and flatal incontinence at 24 weeks postpartum in primiparous women sustaining an OASI.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166399
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of California San Diego|
|La Jolla, California, United States, 92037|
|United States, Illinois|
|Maywood, Illinois, United States, 60153|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15260|
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Study Chair:||Holly E Richter, PhD, MD||University of Alabama at Birmingham|