Clinical trial NCT01166399: Behavioral Therapy Of Obstetric Sphincter Tears
Official title: BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Keywords: Fecal Incontinence,
bowel incontinence,
pelvic floor disorder
Lead sponsor: NICHD Pelvic Floor Disorders Network
Sponsor class: NETWORK
Collaborators: name: Office of Research on Women's Health (ORWH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-07-21
Enrollment: 362
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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:

1. To determine the incidence rates of FI symptoms at 24 weeks post delivery in primiparous women sustaining an OASI
2. To examine the relationship between the modified WHO sphincter tear classification types and FI symptoms
3. To examine predictors (socio-demographic, physical and clinical) associated with WHO sphincter tear classifications (3a, 3b and 4) and predictors associated with FI symptoms
4. To evaluate the incidence of fecal urgency and flatal incontinence at 24 weeks postpartum in primiparous women sustaining an OASI.

Eligibility criteria: Inclusion Criteria Assessed by 2 weeks postpartum

1. Vaginal delivery \>= 28 weeks singleton gestation
2. Documented repair to the anal sphincter at delivery
3. First vaginal delivery
4. Ambulatory
5. Able to give informed consent 6 Adult women \>= 18 years of age

Inclusion Criteria at 2 weeks postpartum

1. Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease)
2. Pre-pregnancy ano-rectal surgery (e.g., surgery for hemorrhoids, fissures, sphincterotomy)
3. 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)
4. Neurological condition that would predispose to FI (e.g., spinal cord injury, multiple sclerosis)
5. Presence of rectovaginal fistula
6. Any participation in other pharmacologic or behavioral studies for FI
7. Previous pregnancy \>=28 weeks delivered vaginally or by Cesarean section

Primary outcomes:
measure: Incidence of FI
timeFrame: 6 and 12 months postpartum
Secondary outcomes:
measure: Incidence of FI
timeFrame: 24 weeks postpartum
measure: Fecal urgency
timeFrame: 24 weeks postpartum
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Alabama at Birmingham
name: Holly E Richter, PhD, MD
role: STUDY_CHAIR
References:
citation: 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.