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Behavioral Therapy Of Obstetric Sphincter Tears (BOOST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01166399
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : September 10, 2020
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):
NICHD Pelvic Floor Disorders Network

Study Description
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Brief Summary:
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 or disease
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 Design
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Study Type : Observational
Actual Enrollment : 362 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study
Study Start Date : July 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of FI [ Time Frame: 6 and 12 months postpartum ]
    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 :
  1. Incidence of FI [ Time Frame: 24 weeks postpartum ]
    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.

  2. Fecal urgency [ Time Frame: 24 weeks postpartum ]
    Fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166399


Locations
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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
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Study Chair: Holly E Richter, PhD, MD University of Alabama at Birmingham
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier: NCT01166399    
Other Study ID Numbers: 20P01
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Keywords provided by NICHD Pelvic Floor Disorders Network:
Fecal Incontinence,
bowel incontinence,
pelvic floor disorder
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases