Clinical trial NCT00729144: Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial
Official title: Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Keywords: fecal incontinence
bowel incontinence
pelvic floor disorder
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: Office of Research on Women's Health (ORWH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-08-07
Enrollment: 133
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with a primary complaint of FI (with or without UI or POP) who are seeking treatment

Brief summary: This study focuses on the validation of the Adaptation Index instrument as a measurement of adaptive behaviors used to reduce symptoms of FI and to describe the use of adaptive behaviors among women with FI.

Detailed description: It is common knowledge that women with pelvic floor dysfunction will develop, initiate and adopt behaviors which mitigate their symptoms or impairment. For some women, this involves wearing a pad and for others, knowledge of restroom locations. Little is known about the role of such behaviors in helping women adapt to urinary incontinence (UI), pelvic organ prolapse (POP), or fecal incontinence (FI). Additionally, there are no studies that address the persistence of these behaviors following treatment as measured by traditional outcomes. Results of a pilot study that assessed quality of life (QOL) in women with pelvic floor disorders (PFD) indicated that women relied heavily on behavioral adaptation in order to cope with PFD symptoms. Subsequently, a draft Adaptation Index was developed with input from investigators of the Pelvic Floor Disorders Network (PFDN). This measure was further refined by focus groups as part of the 1J06 protocol. The 1J06 study is investigating the properties of this tool in subjects with UI and POP. This study focuses on the validation of this instrument as a measurement of adaptive behaviors used to reduce symptoms of FI and to describe the use of adaptive behaviors among women with FI.

Eligibility criteria: Inclusion Criteria:

* Primary complaint of FI with liquid, solid stool, or mucous incontinence, occurring at least monthly for 3 consecutive months. These women are planning to have treatment for FI.
* Women with prior treatment, including surgery for their FI, UI, and/or POP may be included if they now have a primary complaint of FI as defined above and are planning to have additional or new treatment for FI.

Exclusion Criteria:

* Diagnosis of interstitial cystitis, , bladder or colo-rectal malignancy or inflammatory bowel disease
* Refusal or inability to provide written consent
* Inability to complete telephone interviews conducted in English or Spanish
* Prior pelvic irradiation
* Incontinence only to flatus
* Prior removal of any portion of the colon or rectum
* Current or history of rectovaginal fistula(e)
* Rectal prolapse
* Neurologic disorders known to affect continence, including Multiple Sclerosis, Spinal Cord Injury, Debilitating Stroke, and Parkinson's Disease

Primary outcomes:
measure: Adaptation Index and domains
timeFrame: baseline, 2 wk, 3 mo, 12 mo
Secondary outcomes:
measure: Fecal Incontinence Severity Index (FISI)
timeFrame: baseline, 2 wk, 3 mo, 12 mo
measure: Medical Outcome Study Short-Form (SF-12)
timeFrame: baseline, 3 mo, 12 mo
measure: Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ)
timeFrame: baseline, 3 mo, 12 mo
measure: Modified Manchester Health Questionnaire
timeFrame: baseline, 3 mo, 12 mo
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 3 mo, 12 mo
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: University of California, San Diego Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
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: The University of Alabama at Birmingham
name: Holly E Richter, PhD, MD
role: STUDY_CHAIR
affiliation: The University of Alabama at Birmingham
name: Alayne Markland, MD
role: STUDY_CHAIR
References:
citation: Jelovsek JE, Chen Z, Markland AD, Brubaker L, Dyer KY, Meikle S, Rahn DD, Siddiqui NY, Tuteja A, Barber MD. Minimum important differences for scales assessing symptom severity and quality of life in patients with fecal incontinence. Female Pelvic Med Reconstr Surg. 2014 Nov-Dec;20(6):342-8. doi: 10.1097/SPV.0000000000000078.
citation: Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.