Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation: A Comparative Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- anal sphincter muscle activity
研究概览
简要总结
This study aimed to investigate and compare the effect of electrical stimulation and biofeedback with electrical stimulation alone on fecal incontinence in children with repaired imperforate anus, with ages from 6 to 10 years.
详细描述
A comparative, randomized, clinical trial regarding children who complain of fecal incontinence after operative repair of imperforate anus, to evaluate the effect of biofeedback assisted pelvic floor muscles training through animated games combined with anal electrical stimulation and anal electrical stimulation with pelvic floor muscles training through measuring anal muscles activity and implementing a bowel diary.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
who run the randomization process
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with repaired anorectal malformation
- •evident spared anal sphincter muscles by MRI
- •the age range from 6 to 10 years
- •able to follow instructions
- •Faecal symptoms will be evaluated for a month to confirm study eligibility.
排除标准
- •children with absent anal sphincter muscles by MRI
- •children with post-colon surgery other than ARM
- •neurologic/neuropathic disorder
- •sensory or hearing deficits
- •psychological disturbances.
研究组 & 干预措施
ES group
receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy
干预措施: behavioral therapy (Behavioral)
ES group
receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy
干预措施: electrical stimulation (Device)
ES group
receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy
干预措施: pelvic floor muscles training (Other)
Combined group
receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy
干预措施: electrical stimulation (Device)
Combined group
receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy
干预措施: behavioral therapy (Behavioral)
Combined group
receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy
干预措施: biofeedback (Device)
结局指标
主要结局
anal sphincter muscle activity
时间窗: before and after 3 months of treatment
The anal sphincter muscles, comprising the internal and external sphincters, play a critical role in maintaining continence and regulating the release of feces. In the context of fecal incontinence in children with repaired anorectal malformation, the activity of these muscles is crucial for understanding their functional restoration post-surgery. Electrical stimulation and biofeedback therapies aim to enhance the tone and coordination of these muscles, improving their ability to control defecation. By assessing the activity of the anal sphincter muscles through method like pressure measurement, the study will determine how these interventions influence muscle function and whether they contribute to a reduction in fecal incontinence episodes. The analysis of sphincter muscle activity is key in evaluating the effectiveness of these therapies in strengthening the muscles and improving overall bowel control.
次要结局
- fecal soiling frequency(a weak before treatment and the last weak of treatment)
研究者
Amany Gomaa Atiaa
Lecturer
Sinai University