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Behavioral Therapy Of Obstetric Sphincter Tears

NCT01166399 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 362

Last updated 2020-09-10

No results posted yet for this study

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.

Conditions

  • Fecal Incontinence

Sponsors & Collaborators

  • Office of Research on Women's Health (ORWH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • NICHD Pelvic Floor Disorders Network

    lead NETWORK

Principal Investigators

  • Holly E Richter, PhD, MD · University of Alabama at Birmingham

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-06-30
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166399 on ClinicalTrials.gov