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临床试验/NCT04472923
NCT04472923已完成不适用

Effect of Biofeedback Training on Functional Non-Retentive Fecal Incontinence in Children

Batterjee Medical College1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2018年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Number of incontinence episodes

研究概览

简要总结

Fecal incontinence (FI) is the inability to control bowel movements, causing stool to leak from rectum it ranges from an occasional leakage of stool while passing gas to a complete loss of bowel control after the age of 4 years1. Functional non-retentive fecal incontinence (FNRFI) is fecal incontinence in a child with a mental age of more than 4 years with no evidence of metabolic, inflammatory, or anatomical cause2.

The long-term result of biofeedback therapy is one of the most important subjects of controversy, and few studies have extended to 2 years of follow-up 11. So, the purpose of this study was to evaluate quantitatively the short-term and long-term efficacy of biofeedback training as a treatment tool designed to control functional non-retentive fecal incontinence in children and its long term impact on the quality of life.

详细描述

Functional non-retentive fecal incontinence (FNRFI) is fecal incontinence in a child with a mental age of more than 4 years with no evidence of metabolic, inflammatory, or anatomical cause2.

It is an extremely embarrassing and psychologically frustrating shameful problem with a bad impact on children3. It can lead to social isolation, loss of self-confidence, depression, and behavioral problems4. The underlying mechanism of functional non-retentive fecal incontinence is largely unknown. The pathophysiology seems to be complex and it is considered to be a multifactorial disorder5. Approximately 95% of the children had no organic cause and these children are considered to have a functional defecation disorder. Of this, in approximately 80% of these children FI is results of constipation and is treated with laxatives, the remaining 20% without signs of fecal retention is classified as FNRFI6 The negative psychological and social impact for these children is high, however, and requires adequate intervention7. Biofeedback therapy is a feasible option that has been used for fecal incontinence over several decades8. The underlying premise of biofeedback, as with learning any physical activity, is that "practice makes perfect" if the learner is provided with accurate feedback to make adjustments to optimize performance So, the purpose of this study was to evaluate quantitatively the short-term and long-term efficacy of biofeedback training as a treatment tool designed to control functional non-retentive fecal incontinence in children and its long term impact on the quality of life.

Methods:

The present study included 100 children of both sexes that were included with an age ranged from (5-14 years) with FNRFI with normal bowel habits, normal defecation frequency, and normal stool consistency with incontinence score ranging from 6-24 according to Vaizey score 12. Exclusion criteria included; children who have traumatic sphincter injury, fecal impaction, spinal diseases causing incontinence, anorectal malformation, and children who were not cooperative. Patients included in this study were randomly divided and allocated into two groups Control group and Study group. Written informed consent was obtained from parents of all included children.

A detailed history was taken including bowel habits, duration history of trauma. Complete physical examination to exclude patients requiring surgical correction.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age ranged from (5-14 years) with FNRFI with normal bowel habits
  • •Children with normal defecation frequency and normal stool consistency
  • •Children with incontinence score ranging from 6-24 according to Vaizey score

排除标准

  • •Children who have traumatic sphincter injury.
  • •Children who have Fecal impaction
  • •Children who have Spinal diseases causing incontinence
  • •Children who have Anorectal malformation
  • •Children who were not cooperative

研究组 & 干预措施

Control group

Active Comparator

Patients belonging to the control group received conventional physical therapy program in the form of diet and Kegel exercises.

干预措施: Traditional Treatment (Procedure)

Study group

Experimental

Patients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training

干预措施: Biofeedback (Device)

结局指标

主要结局

Number of incontinence episodes

时间窗: 24 months

Change in the number of incontinence episodes

Incontinence Score using Vaizey incontinence score

时间窗: 24 months

Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

次要结局

  • Fecal Incontinence Quality of life Score(24 months)
  • Resting pressure (mm hg)(3 months)
  • Squeeze pressure (mm hg)(3 months)
  • First sensation (volume of the balloon by cm water)(3 months)
  • First Urge (volume of the balloon by cm water)(3 months)
  • Intense urge (volume of the balloon by cm water)(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed A. Abdel Ghafar

Associate Professor of Physical Therapy

Batterjee Medical College

研究点 (1)

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