Behavioral Therapy Of Obstetric Sphincter Tears (BOOST)

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.

Study Overview

• Status: Completed
• Conditions: 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:

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 (Actual): 362

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 and 12 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks postpartum
Fecal urgency	Fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire	24 weeks postpartum

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Richter HE, Nager CW, Burgio KL, Whitworth R, Weidner AC, Schaffer J, Zyczynski HM, Norton P, Jelovsek JE, Meikle SF, Spino C, Gantz M, Graziano S, Brubaker L; NICHD Pelvic Floor Disorders Network. Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women. Female Pelvic Med Reconstr Surg. 2015 Jul-Aug;21(4):182-9. doi: 10.1097/SPV.0000000000000160.

Helpful Links

• Network website

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: July 19, 2010
• First Submitted That Met QC Criteria: July 19, 2010
• First Posted (Estimate): July 21, 2010

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Fecal Incontinence,; bowel incontinence,; pelvic floor disorder
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 20P01