Comparison of Posterior Tibial Nerve Stimulation and Biofeedback for Fecal Incontinence: Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 12
- 主要终点
- Weekly episodes of fecal incontinence
研究概览
简要总结
Until recently, there is no definite treatment for fecal incontinence that is proven to be effective with low morbidity. The efficacy of biofeedback therapy for incontinence has not been proven on the randomized controlled trials. Sacral nerve stimulation is too expensive although some prospective studies showed the therapeutic potential. Recently, posterior tibial nerve stimulation has been reported to be effective with lower cost in comparison with sacral nerve stimulation. This study is designed to show the efficacy of posterior tibial nerve stimulation compared with biofeedback therapy for fecal incontinence.
详细描述
This prospective randomized controlled trial is designed to compare the efficacy of biofeedback and posterior tibial nerve stimulation for fecal incontinence. Primary endpoint is weekly episodes of fecal incontinence at 1 week after each treatment. Sample size was calculated as 50 patients. Outcomes include weekly episodes and severity of fecal incontinence, quality of life and anal function. Outcomes will be assessed using bowel diary, FISI questionnaire, FIQL questionnaire and anorectal manometry at 1,8,16 and 24 weeks after each treatment for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with 2 or more weekly episodes of fecal incontinence
- •Patient who understands and accepts to sign the informed consent form
排除标准
- •Patient with gas incontinence only
- •Major injury in anal sphincter
- •Anorectal operation history within 24 months
- •Previous spinal injury, tumor or surgery
- •Presence of neurological disease
- •Peripheral vascular disease
- •Severe comorbidity
- •Psychiatric disorder
- •Legally prohibited for clinical trial
- •Pregnancy or breast feeding
- •Previous disease or disability expected to influence the assessment of postoperative quality of life
结局指标
主要结局
Weekly episodes of fecal incontinence
时间窗: 1 week
Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)
次要结局
- Weekly episodes of fecal incontinence(6 months)
- Severity of fecal incontinence(6 months)
- Quality of life associated with fecal incontinence(6 months)
- Anal function(6 months)
研究者
Sung-Bum Kang
Principal Investigator
Seoul National University Bundang Hospital