Clinical, Anatomic, and Physiologic Characteristics of Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Fecal incontinence severity as measured by mean Vaizey score
研究概览
简要总结
Fecal incontinence (FI) is clinically subtyped as urge FI and passive FI based on symptoms, however the pathophysiologic significance of this subtyping is not known. FI is commonly encountered in women with pelvic floor disorders. This study aims to compare characteristics of clinical severity, quality of life, anatomy, and physiology of urge FI versus passive FI. Urogynecology patients greater than age 18 with FI at least monthly over the last 3 months will be recruited for participation. Participants will be divided into urge FI subtype and passive FI subtype. Participants will complete validated questionnaires on clinical severity and quality of life, both as related to FI and general heath. Participants will undergo pelvic examination, endoanal ultrasound and anorectal manometry for evaluation of anatomic and physiologic pathology. Results between both groups will be compared. The investigators hypothesize that clinical, anatomic, and physiologic characteristics differ between urge-predominant fecal incontinence and passive-predominant fecal incontinence in women with pelvic floor disorders.
详细描述
Fecal incontinence greatly affects quality of life and can negatively impact an individual's activity level, body image, and likelihood of institutionalization. Female sex and advancing age are known independent risk factors for fecal incontinence. Among community dwelling adults, the prevalence of fecal incontinence has ranged from 0.4 to 18 percent. Prevalence rates of fecal incontinence are even higher in women with pelvic floor disorders, reaching up to 41%, illustrating the large bearing on quality of life of this patient population.
Fecal incontinence can be subtyped into three clinical subtypes: urge fecal incontinence, passive fecal incontinence, and fecal seepage. Urge incontinence refers to loss of fecal matter in spite of active attempts to retain contents; passive incontinence refers to involuntary loss of stool without awareness. Despite the clinical distinction of fecal incontinence subtypes, the pathophysiology of these subtypes is not known. Existing practice guidelines recommend categorizing patients into these subtypes, evaluating symptom severity by patient-reported outcomes, and assessing function of the anorectal complex with imaging and physiologic tests to best tailor management options. Although the framework for subtyping fecal incontinence exists, specific associations between subtypes and clinical, anatomic, and physiologic findings in women with pelvic floor disorders are not well delineated. Further characterizing the subtypes in relation to specific clinical, anatomic, and physiologic findings may allow us to better approach the treatment of women with fecal incontinence.
Our comparison of the two fecal incontinence subtypes, urge-predominant fecal incontinence and passive fecal incontinence, will be evaluated for clinical severity, impact on quality of life, and anatomic and physiologic characteristics using validated instruments.
Primary Aim:
To compare the severity of urge fecal incontinence versus passive fecal incontinence in women with pelvic floor disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women greater than age 18 with fecal incontinence at least monthly over the last 3 months
排除标准
- •Malignancy
- •Rectal prolapse
- •Prior colorectal surgery
- •Prior radiation
- •Fecal impaction
- •Sole flatal incontinence
- •Neurologic disorders
结局指标
主要结局
Fecal incontinence severity as measured by mean Vaizey score
时间窗: Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.
Vaizey score range 0 to 24
次要结局
- Anal anatomy patency as measured by mean anal sphincter complex thickness (millimeters).(Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.)
- Anal anatomy patency as measured by presence or absence of defects using endoanal ultrasound.(Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.)
- Anal function as measured by the anorectal manometry measurements (see description below).(Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.)
- Rectal function as measured by the anorectal manometry measurements (see description below).(Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.)