NCT01166399
Behavioral Therapy Of Obstetric Sphincter Tears
COMPLETED
NCT01166399
OBSERVATIONAL
BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study
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.
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
Fecal Incontinence
- NICHD Pelvic Floor Disorders Network