Behavioral Therapy Of Obstetric Sphincter Tears

Completed

Conditions studied: Fecal Incontinence

In brief

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.

Key facts

Study ID

NCT01166399

Run by

NICHD Pelvic Floor Disorders Network

People needed

362

Starts

2010-07-01

Expected to finish

2012-10-01

Last updated by the study team

2020-09-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California San Diego — La Jolla, California, United States
• Loyola University — Maywood, Illinois, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.