Behavioral Therapy Of Obstetric Sphincter Tears

NICHD Pelvic Floor Disorders Network362 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

362

Conditions

Fecal Incontinence

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California San Diego

La Jolla, California, United States

Loyola University

Maywood, Illinois, United States

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Incidence of FI

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.

Time frame: 6 and 12 months postpartum

Secondary Outcomes

Incidence of FI

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.

Time frame: 24 weeks postpartum

Fecal urgency

Fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire

Time frame: 24 weeks postpartum

Data from ClinicalTrials.gov

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