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| ID | Type | Description | Link |
|---|---|---|---|
| U01HD041249 | U.S. NIH Grant/Contract | View source | |
| U10HD041250 | U.S. NIH Grant/Contract | View source | |
| U10HD041261 | U.S. NIH Grant/Contract | View source | |
| U10HD041267 | U.S. NIH Grant/Contract | View source | |
| U10HD054136 | U.S. NIH Grant/Contract | View source | |
| U10HD054214 | U.S. NIH Grant/Contract | View source | |
| U10HD054215 | U.S. NIH Grant/Contract | View source | |
| U10HD054241 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Office of Research on Women's Health (ORWH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Adaptation Index and domains | baseline, 2 wk, 3 mo, 12 mo |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Incontinence Severity Index (FISI) | baseline, 2 wk, 3 mo, 12 mo | |
| Medical Outcome Study Short-Form (SF-12) | baseline, 3 mo, 12 mo | |
| Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) |
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Inclusion Criteria:
Exclusion Criteria:
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women with a primary complaint of FI (with or without UI or POP) who are seeking treatment
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| Name | Affiliation | Role |
|---|---|---|
| Holly E Richter, PhD, MD | The University of Alabama at Birmingham | Study Chair |
| Alayne Markland, MD | The University of Alabama at Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| University of California, San Diego Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25185630 | Derived | 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. | |
| 21344495 | Derived | 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. |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| baseline, 3 mo, 12 mo |
| Modified Manchester Health Questionnaire | baseline, 3 mo, 12 mo |
| Patient Global Impression of Improvement (PGI-I) | 3 mo, 12 mo |
| La Jolla |
| California |
| 92037 |
| United States |
| Kaiser Permanente | San Diego | California | 92120 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |