Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Stablish a correlation between Wexner fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence
研究概览
简要总结
The purpose of this study is to stablish a correlation between fecal incontinence severity scales (Wexner & St. Mark's) and manometric values obtained using the Anopress® portable manometry and values obtained using endoanal ultrasound in women with fecal incontinence.
详细描述
The Anopress® portable anal manometry will be used to measure the pressures of the anal canal in different phases: rest, squeeze, strain and endurance.
All female patients referred with the diagnosis of fecal incontinence giving written informed consent will undergo a endoanal portable manometry at our outpatients clinics. They will be asked to fill out the severity questionaries (Sant Mark's and Wexner). All data will be collected for analysis.
An endoanal ultrasound will be performed in all patients to assess the sphincter integrity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with the clinical diagnosis of fecal incontinence
- •Age ≥ 18 years.
- •Informed consent signed by the patient and the researcher.
排除标准
- •Patients with psychiatric illnesses, addictions or any disorder that prevents understanding of the study.
- •Inability to read or understand the questionnaires.
- •Inability to read or understand any of the informed consent languages (Catalan, Spanish).
- •Any patient who, due to his medical characteristics, presents a high individual risk when being included and completing the study.
结局指标
主要结局
Stablish a correlation between Wexner fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence
时间窗: During the procedure
Spearman and Pearson correlation will be used to assess correlations between values
Stablish a correlation between St. Mark's fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence
时间窗: During the procedure
Spearman and Pearson correlation will be used to assess correlations between values
次要结局
- Stablish a correlation between St.Mark's fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence(During the procedure)
- Stablish a correlation between Wexner fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence(During the procedure)