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Behavioral Therapy Of Obstetric Sphincter Tears (BOOST)
This study has been completed.
Sponsor:
NICHD Pelvic Floor Disorders Network
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
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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.
| 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:
Further study details as provided by dwallace, RTI International:
Primary Outcome Measures:
- 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:
- 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.
- 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
| 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 |
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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.
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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:
- To determine the incidence rates of FI symptoms at 24 weeks post delivery in primiparous women sustaining an OASI
- To examine the relationship between the modified WHO sphincter tear classification types and FI symptoms
- To examine predictors (socio-demographic, physical and clinical) associated with WHO sphincter tear classifications (3a, 3b and 4) and predictors associated with FI symptoms
- 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 (Adult, Senior) |
| 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
- Vaginal delivery >= 28 weeks singleton gestation
- Documented repair to the anal sphincter at delivery
- First vaginal delivery
- Ambulatory
- Able to give informed consent 6 Adult women >= 18 years of age
Inclusion Criteria at 2 weeks postpartum
- Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease)
- Pre-pregnancy ano-rectal surgery (e.g., surgery for hemorrhoids, fissures, sphincterotomy)
- 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)
- Neurological condition that would predispose to FI (e.g., spinal cord injury, multiple sclerosis)
- Presence of rectovaginal fistula
- Any participation in other pharmacologic or behavioral studies for FI
- Previous pregnancy >=28 weeks delivered vaginally or by Cesarean section
Contacts and Locations
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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
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by dwallace, RTI International:
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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 |
ClinicalTrials.gov processed this record on August 21, 2017