Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 8
- 主要终点
- Adaptation Index and domains
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Adaptation Index and domains
时间窗: baseline, 2 wk, 3 mo, 12 mo
次要结局
- 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)(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)