Behavioral Therapy Of Obstetric Sphincter Tears (BOOST)

NICHD Pelvic Floor Disorders Network

Status: Completed

Conditions: Fecal Incontinence

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01166399

20P01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 362 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Assessed by 2 weeks postpartum

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

Inclusion Criteria at 2 weeks postpartum

1. Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease)
2. Pre-pregnancy ano-rectal surgery (e.g., surgery for hemorrhoids, fissures, sphincterotomy)
3. 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)
4. Neurological condition that would predispose to FI (e.g., spinal cord injury, multiple sclerosis)
5. Presence of rectovaginal fistula
6. Any participation in other pharmacologic or behavioral studies for FI
7. Previous pregnancy >=28 weeks delivered vaginally or by Cesarean section

Trial design

362 participants in 1 patient group

Primiparous women with an obstetric anal sphincter tear

Description:

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.