Biofeedback Training Fecal Incontinence in Children
Primary Purpose
Fecal Incontinence in Children
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Traditional Treatment
Biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence in Children focused on measuring Fecal incontinence, Biofeedback, long-term, Children
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
Sites / Locations
- Benha University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Study group
Arm Description
Patients belonging to the control group received conventional physical therapy program in the form of diet and Kegel exercises.
Patients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training
Outcomes
Primary Outcome Measures
Number of incontinence episodes
Change in the number of incontinence episodes
Incontinence Score using Vaizey incontinence score
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
Secondary Outcome Measures
Fecal Incontinence Quality of life Score
Change in quality of life score measured on a scale between 1 and 4, where 1 is very affected and 4 is not affected
Resting pressure (mm hg)
Pressure during relaxation of the anal sphincter
Squeeze pressure (mm hg)
Pressure during contraction of the anal sphincter
First sensation (volume of the balloon by cm water)
First sensation of the stool in the rectum
First Urge (volume of the balloon by cm water)
The patient is trying to hold defecation and he can
Intense urge (volume of the balloon by cm water)
The Patent can no longer control the defecation
Full Information
NCT ID
NCT04472923
First Posted
July 7, 2020
Last Updated
July 12, 2020
Sponsor
Batterjee Medical College
Collaborators
Benha University
1. Study Identification
Unique Protocol Identification Number
NCT04472923
Brief Title
Biofeedback Training Fecal Incontinence in Children
Official Title
Effect of Biofeedback Training on Functional Non-Retentive Fecal Incontinence in Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2018 (Actual)
Primary Completion Date
June 4, 2020 (Actual)
Study Completion Date
July 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Batterjee Medical College
Collaborators
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence in Children
Keywords
Fecal incontinence, Biofeedback, long-term, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients belonging to the control group received conventional physical therapy program in the form of diet and Kegel exercises.
Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training
Intervention Type
Procedure
Intervention Name(s)
Traditional Treatment
Other Intervention Name(s)
Diet and exercises
Intervention Description
Patients belonging to the control group received conventional physical therapy program in the form of:
Dietetic Regulation: The diet was given in the form of the bulk-forming diet, fruits, vegetables, cereals, and bran.
Pelvic floor muscle exercises (Kegal exercises): The patient was instructed to lie crock lying position with knees bent. He/she was instructed to pull his/her pelvic muscles upward and inward and hold the contraction for 6 seconds as if to hold back a defecation movement, followed by relaxation for 6 seconds. The exercise was repeated 25 times. Gradually increase the time until reaching 10 seconds of contraction and relaxation for each with repetition up to 30 times. The exercises applied twice per week for 3 months.
Intervention Type
Device
Intervention Name(s)
Biofeedback
Intervention Description
Patients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training.
Biofeedback was planned after full guardians' education. Local hygiene for perianal skin for soiling episodes and using zinc oxide cream to prevent excoriation. Biofeedback was done using two types of catheters; a 24-channel water-perfused catheter with latex balloon for sensory training and a double-lumen rectal PVC balloon clothed catheter (MMS U-72210) for strength training. Each biofeedback session took 30 minutes with two sessions per week for 3 months.
Primary Outcome Measure Information:
Title
Number of incontinence episodes
Description
Change in the number of incontinence episodes
Time Frame
24 months
Title
Incontinence Score using Vaizey incontinence score
Description
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Fecal Incontinence Quality of life Score
Description
Change in quality of life score measured on a scale between 1 and 4, where 1 is very affected and 4 is not affected
Time Frame
24 months
Title
Resting pressure (mm hg)
Description
Pressure during relaxation of the anal sphincter
Time Frame
3 months
Title
Squeeze pressure (mm hg)
Description
Pressure during contraction of the anal sphincter
Time Frame
3 months
Title
First sensation (volume of the balloon by cm water)
Description
First sensation of the stool in the rectum
Time Frame
3 months
Title
First Urge (volume of the balloon by cm water)
Description
The patient is trying to hold defecation and he can
Time Frame
3 months
Title
Intense urge (volume of the balloon by cm water)
Description
The Patent can no longer control the defecation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad M Abdelrahman, M.D.
Organizational Affiliation
Bnha University
Official's Role
Study Director
Facility Information:
Facility Name
Benha University
City
Banhā
State/Province
Al Qalyubia Governorate
ZIP/Postal Code
13511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After Publication, the investigators would like to share the data with other researchers who interested in this topic
IPD Sharing Time Frame
After publication
IPD Sharing Access Criteria
Not available now
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