Body Image Scale - Analysis - SAS in Controlling Anal Incontinence by Performing Anal Exercises with Biofeedback or Loperamide: a Randomized Placebo Controlled Trial

Body Image Scale
Study Description
The goals of this trial are to compare the use of loperamide to oral placebo and to compare the use of anal sphincter exercise training with biofeedback to usual care (educational pamphlet) in the treatment of women suffering from fecal incontinence (FI). We will test the following null hypotheses: there is no difference in outcomes between women randomized to loperamide and women randomized to oral placebo for treatment of FI; there is no difference in outcomes between women randomized to anal sphincter exercises with biofeedback and women randomized to usual care (educational pamphlet) for FI treatment; there is no difference between women randomized to both treatments together and women randomized to either FI treatment alone; and there is no correlation between anal manometry measurements and digital anal squeeze strength or measures of FI severity and bother. Women who seek treatment for fecal incontinence, also known as accidental bowel leakage.

身体意象量表（Body Image Scale）
研究描述
本试验的核心目标为对比洛哌丁胺（loperamide）与口服安慰剂（oral placebo）的临床应用效果，同时比较生物反馈辅助肛门括约肌训练（anal sphincter exercise training with biofeedback）与常规护理（健康教育手册，usual care (educational pamphlet)）在女性大便失禁（Fecal Incontinence, FI）治疗中的疗效。本研究将检验以下四项无效假设（null hypotheses）：随机分配至洛哌丁胺组的女性大便失禁患者与随机分配至口服安慰剂组的患者，其治疗结局无显著差异；随机分配至生物反馈辅助肛门括约肌训练组的患者与随机分配至常规护理（健康教育手册）组的患者，其治疗结局无显著差异；同时接受两种联合治疗的女性与仅接受任一单一FI治疗方案的女性，其治疗结局无显著差异；肛门测压法（anal manometry）测量结果与指诊肛门挤压力（digital anal squeeze strength），或大便失禁严重程度与困扰程度的相关指标之间不存在相关性。本研究的纳入对象为寻求大便失禁（也称为意外肠漏，accidental bowel leakage）治疗的女性。