BOOST: Behavioral Therapy Of Obstetric Sphincter Tears

Sponsor

NICHD Pelvic Floor Disorders Network (Other)

Overall Status

Completed

CT.gov ID

NCT01166399

Collaborator

Office of Research on Women's Health (ORWH) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

362

Enrollment

Locations

Duration (Months)

45.3

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence

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:

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.

Study Design

Study Type:

Observational

Actual Enrollment :

362 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Incidence of FI [6 and 12 months postpartum]
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.

Secondary Outcome Measures

Incidence of FI [24 weeks postpartum]
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 [24 weeks postpartum]
Fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria Assessed by 2 weeks postpartum

Vaginal delivery >= 28 weeks singleton gestation
Documented repair to the anal sphincter at delivery
First vaginal delivery
Ambulatory
Able to give informed consent 6 Adult women >= 18 years of age

Inclusion Criteria at 2 weeks postpartum

Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease)
Pre-pregnancy ano-rectal surgery (e.g., surgery for hemorrhoids, fissures, sphincterotomy)
Pre-pregnancy FI (defined as the leakage of liquid/solid stool and mucus >= once per month for at least 12 weeks prior to this pregnancy)
Neurological condition that would predispose to FI (e.g., spinal cord injury, multiple sclerosis)
Presence of rectovaginal fistula
Any participation in other pharmacologic or behavioral studies for FI
Previous pregnancy >=28 weeks delivered vaginally or by Cesarean section

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of California San Diego	La Jolla	California	United States	92037
3	Loyola University	Maywood	Illinois	United States	60153
4	Duke University	Durham	North Carolina	United States	27710
5	Cleveland Clinic	Cleveland	Ohio	United States	44195
6	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15260
7	University of Texas Southwestern	Dallas	Texas	United States	75390
8	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

NICHD Pelvic Floor Disorders Network
Office of Research on Women's Health (ORWH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)