Behavioral Therapy Of Obstetric Sphincter Tears

NCT01166399 | Completed DMC

• 1 other identifier: 20P01
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 8

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.

Conditions

Fecal Incontinence

Keywords

Fecal Incontinence,; bowel incontinence,; pelvic floor disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  6 and 12 months postpartum

Secondary Outcomes (2)

• Incidence of FI

  24 weeks postpartum

• Fecal urgency

  24 weeks postpartum

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead
• Office of Research on Women's Health (ORWH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Richter HE, Nager CW, Burgio KL, Whitworth R, Weidner AC, Schaffer J, Zyczynski HM, Norton P, Jelovsek JE, Meikle SF, Spino C, Gantz M, Graziano S, Brubaker L; NICHD Pelvic Floor Disorders Network. Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women. Female Pelvic Med Reconstr Surg. 2015 Jul-Aug;21(4):182-9. doi: 10.1097/SPV.0000000000000160.

  PMID: 25679358 DERIVED

MeSH Terms

Conditions

Fecal Incontinence; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Holly E Richter, PhD, MD

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2012
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

US (8)