An observational study in Fecal Incontinence, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 8 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2011-01-11.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational
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.
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.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 133 is above the median of 100 across 79 observational studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
women with a primary complaint of FI (with or without UI or POP) who are seeking treatment
Exclusion Criteria:
Adaptation Index and domains
Time frame: baseline, 2 wk, 3 mo, 12 mo
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
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)