BOOST: Behavioral Therapy Of Obstetric Sphincter Tears -- Behavioral Therapy versus Usual Care in Primiparous Women with Anal Sphincter Tears and Fecal Incontinence: A Randomized Trial

Overview

Status: Active, not recruiting
Keywords: Fecal Incontinence , Pregnancy , Labor and Delivery
IRB Number: 00043067
Specialty: Urogyn and Pelvic Reconstructive Surgery
Sub Specialties:

Brief Summary

Approximately 5% of women sustain an obstetric anal sphincter injury at their first delivery; of these, about 20% report fecal incontinence postpartum. Over the next 6 months, many women improve, but some don't. Currently, the standard of care is simply expectant management with no treatment. In this cohort study determine the incidence of FI symptoms at 6 and 12 weeks postpartum in primiparous women sustaining an OSASI. .
 
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 primpiarous women sustaining an OASI.
 

Principal Investigator: Ingrid Nygaard
Department: Urogynecology
Co Investigator:

Contact Information

Name:Linda Griffen
Phone: 801-581-7038
Email: linda.griffen@hsc.utah.edu

Inclusion 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 and older
 

 

Exclusion Criteria

Exclusion Criteria Assessed by 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