Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents is Effective for the Treatment of Fecal Incontinence in Women - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- symptom diary
研究概览
简要总结
Background: Biofeedback and medical treatments have been extensively used for moderate fecal incontinence. There is limited data comparing and combining these two treatments.
Aim: To evaluate the effect of biofeedback and medical treatments, separately and in combination.
Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal incontinence were included. The patients were randomized to start with either biofeedback (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both groups continued with a combination treatments, i.e. medical treatment was added to biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 older than 18 years of age
- •Patients with at least one or more episodes of FI during a period of 2 weeks as recorded by bowel function diary
- •Patients from whom written consent was obtained
排除标准
- •Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
- •Presence of neurological diseases or peripheral vascular disease
- •Uncontrolled diabetes mellitus
- •Congenital anorectal malformations
- •Recent colorectal or gastrointestinal surgery
- •Presence of external full-thickness rectal prolapse
- •Inflammatory bowel disease
- •Chronic diarrhoea
- •Use of tibial nerve or sacral nerve stimulations
- •Ongoing pregnancy
- •Any malignant disease
研究组 & 干预措施
Biofeedback
干预措施: Biofeedback (Behavioral)
medical treatment
干预措施: Loperamide (Drug)
medical treatment
干预措施: Stool bulking agent (stericulia or isphagula husk) (Drug)
combination of the two treatments
干预措施: Combination of biofeedback and medical treatment (Other)
结局指标
主要结局
symptom diary
时间窗: Up to eight months
次要结局
未报告次要终点
研究者
Jenny Sjödahl
PhD
University Hospital, Linkoeping