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Behavioral Therapy Of Obstetric Sphincter Tears (BOOST)

This study has been completed.
Sponsor:
Collaborators:
Office of Research on Women's Health (ORWH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
dwallace, RTI International
ClinicalTrials.gov Identifier:
NCT01166399
First received: July 19, 2010
Last updated: September 27, 2013
Last verified: September 2013
History of Changes
  Purpose

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 Phase
Fecal Incontinence
 Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NICHD Pelvic Floor Disorders Network:

Primary Outcome Measures:
  • Incidence of FI [ Time Frame: 6 and 12 months postpartum ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks postpartum ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks postpartum ] [ Designated as safety issue: No ]
    Fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire
Enrollment: 362
Study Start Date: July 2010
Study Completion Date: October 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166399

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California San Diego
La Jolla, California, United States, 92037
United States, Illinois
Loyola University
Maywood, Illinois, United States, 60153
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
United States, Utah
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)
Investigators
Study Chair: Holly E Richter, PhD, MD University of Alabama at Birmingham
  More Information

Additional Information:
Study survey website  This link exits the ClinicalTrials.gov site
Network website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: dwallace, Project Director, RTI International
ClinicalTrials.gov Identifier: NCT01166399     History of Changes
Other Study ID Numbers: 20P01
Study First Received: July 19, 2010
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by NICHD Pelvic Floor Disorders Network:
Fecal Incontinence,
bowel incontinence,
pelvic floor disorder

Additional relevant MeSH terms:
Fecal Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on March 03, 2015