An observational study in Fecal Incontinence, sponsored by NICHD Pelvic Floor Disorders Network. Completed at 8 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by NICHD Pelvic Floor Disorders Network · Observational
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:
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 362 is above the median of 100 across 79 observational studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →NICHD Pelvic Floor Disorders Network is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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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).
Inclusion Criteria Assessed by 2 weeks postpartum
Inclusion Criteria at 2 weeks postpartum
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.
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
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
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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NICHD Pelvic Floor Disorders Network