Fecal IncontinenceABBINCT00729144
Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial
An observational study of Fecal Incontinence, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fecal Incontinence
- How many people
- 133 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: women with a primary complaint of FI (with or without UI or POP) who are seeking treatment
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
University of California, San Diego Medical Center
La Jolla, California, 92037
Loyola University Medical Center
Maywood, Illinois, 60153
University of Utah
Salt Lake City, Utah, 84132
Kaiser Permanente
San Diego, California, 92120
About this study
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.
Read the 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.
- Conditions
- Fecal Incontinence
- Keywords
- fecal incontinence, bowel incontinence, pelvic floor disorder
- Medical subject headings
- Fecal Incontinence, Pelvic Floor Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation Index and domains
Measured: baseline, 2 wk, 3 mo, 12 mo
Secondary outcomes (5)
Fecal Incontinence Severity Index (FISI)
Measured: baseline, 2 wk, 3 mo, 12 mo
Medical Outcome Study Short-Form (SF-12)
Measured: baseline, 3 mo, 12 mo
Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ)
Measured: baseline, 3 mo, 12 mo
Modified Manchester Health Questionnaire
Measured: baseline, 3 mo, 12 mo
Patient Global Impression of Improvement (PGI-I)
Measured: 3 mo, 12 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Office of Research on Women's Health (ORWH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Holly E Richter, PhD, MD, Study chair, The University of Alabama at BirminghamAlayne Markland, MD, Study chair, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729144
- Sponsor's protocol ID
- 1J06-FI
- Other IDs
- U01HD041249, U10HD041250, U10HD041261, U10HD041267, U10HD054136, U10HD054214, U10HD054215, U10HD054241
- Acronym
- ABBI
- Status last verified
- Oct 2010
- First submitted
- 5 Aug 2008
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25185630Barber 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.
PubMed 21344495
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial
- ClinicalTrials.gov ID
- NCT00729144
- Acronym / sponsor ID
- ABBI / 1J06-FI
- Conditions
- Fecal Incontinence
- Keywords
- fecal incontinence, bowel incontinence, pelvic floor disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Office of Research on Women's Health (ORWH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- women with a primary complaint of FI (with or without UI or POP) who are seeking treatment
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adaptation Index and domains
Time frame: baseline, 2 wk, 3 mo, 12 mo
5 secondary outcomes
Fecal Incontinence Severity Index (FISI)
Time frame: baseline, 2 wk, 3 mo, 12 mo
Medical Outcome Study Short-Form (SF-12)
Time frame: baseline, 3 mo, 12 mo
Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ)
Time frame: baseline, 3 mo, 12 mo
Modified Manchester Health Questionnaire
Time frame: baseline, 3 mo, 12 mo
Patient Global Impression of Improvement (PGI-I)
Time frame: 3 mo, 12 mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
- Derived from this study: PubMed 25185630Jelovsek 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.
- Derived from this study: PubMed 21344495Barber 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.
Related trials for Fecal Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly E Richter, PhD, MD study chair
The University of Alabama at Birmingham
Alayne Markland, MD study chair
The University of Alabama at Birmingham
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Incontinence, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptation Index and domains (time frame: baseline, 2 wk, 3 mo, 12 mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00729144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.