Clinical trial NCT04472923: Biofeedback Training Fecal Incontinence in Children
Official title: Effect of Biofeedback Training on Functional Non-Retentive Fecal Incontinence in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence in Children
Keywords: Fecal incontinence
Biofeedback
long-term
Children
Lead sponsor: Batterjee Medical College
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2020-07-16
Enrollment: 108
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of incontinence episodes
timeFrame: 24 months
measure: Incontinence Score using Vaizey incontinence score
timeFrame: 24 months
Secondary outcomes:
measure: Fecal Incontinence Quality of life Score
timeFrame: 24 months
measure: Resting pressure (mm hg)
timeFrame: 3 months
measure: Squeeze pressure (mm hg)
timeFrame: 3 months
measure: First sensation (volume of the balloon by cm water)
timeFrame: 3 months
measure: First Urge (volume of the balloon by cm water)
timeFrame: 3 months
measure: Intense urge (volume of the balloon by cm water)
timeFrame: 3 months
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: Al Qalyubia Governorate
Study officials:
affiliation: Bnha University
name: Emad M Abdelrahman, M.D.
role: STUDY_DIRECTOR
References: