Fecal Incontinence in ChildrenNCT04472923
Biofeedback Training Fecal Incontinence in Children
A study testing Traditional Treatment and Biofeedback in people with Fecal Incontinence in Children, run by Batterjee Medical College at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Fecal Incontinence in Children
- What is being tested?
- Traditional Treatment and Biofeedback
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2018to 5 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Biofeedback Training on Functional Non-Retentive Fecal Incontinence in Children
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.
Read the 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.
- Conditions
- Fecal Incontinence in Children
- Being tested
- Traditional Treatment, Biofeedback
- Keywords
- Fecal incontinence, Biofeedback, long-term, Children
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional TreatmentProcedure or surgery
Also called Diet and exercises
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.
BiofeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients belonging to the control group received conventional physical therapy program in the form of diet and Kegel exercises. Receives: Procedure: Traditional Treatment |
| Study group | Experimental | Patients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training Receives: Device: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incontinence episodes
Change in the number of incontinence episodes
Measured: 24 months
Incontinence Score using Vaizey incontinence score
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
Measured: 24 months
Secondary outcomes (6)
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
Measured: 24 months
Resting pressure (mm hg)
Pressure during relaxation of the anal sphincter
Measured: 3 months
Squeeze pressure (mm hg)
Pressure during contraction of the anal sphincter
Measured: 3 months
First sensation (volume of the balloon by cm water)
First sensation of the stool in the rectum
Measured: 3 months
First Urge (volume of the balloon by cm water)
The patient is trying to hold defecation and he can
Measured: 3 months
Intense urge (volume of the balloon by cm water)
The Patent can no longer control the defecation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start5 May 2018
- Primary completion4 Jun 2020
- Study completion5 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Incontinence in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Mohamed A. Abdel Ghafar, Batterjee Medical College
- Investigators
- Emad M Abdelrahman, M.D., Study director, Bnha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472923
- Sponsor's protocol ID
- BatterjeeMC
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After Publication, the investigators would like to share the data with other researchers who interested in this topic
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biofeedback Training on Functional Non-Retentive Fecal Incontinence in Children
- ClinicalTrials.gov ID
- NCT04472923
- Acronym / sponsor ID
- BatterjeeMC
- Conditions
- Fecal Incontinence in Children
- Keywords
- Fecal incontinence, Biofeedback, long-term, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Batterjee Medical CollegeUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 5 May 2018 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 5 Jul 2020 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Traditional TreatmentPatients belonging to the control group received conventional physical therapy program in the form of diet and Kegel exercises. |
| Study group | Experimental | Device: BiofeedbackPatients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional TreatmentAlso: Diet and exercisesPatients belonging to the control group received conventional physical therapy program in the form of: 1. Dietetic Regulation: The diet was given in the form of the bulk-forming diet, fruits, vegetables, cereals, and bran. 2. 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. | Procedure or surgery | Control group |
| BiofeedbackPatients 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. | Device | Study group |
Primary outcome
Number of incontinence episodes
Time frame: 24 months
Change in the number of incontinence episodes
Incontinence Score using Vaizey incontinence score
Time frame: 24 months
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
6 secondary outcomes
Fecal Incontinence Quality of life Score
Time frame: 24 months
Resting pressure (mm hg)
Time frame: 3 months
Squeeze pressure (mm hg)
Time frame: 3 months
First sensation (volume of the balloon by cm water)
Time frame: 3 months
First Urge (volume of the balloon by cm water)
Time frame: 3 months
Intense urge (volume of the balloon by cm water)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Individual participant dataSharing planned: Yes. After Publication, the investigators would like to share the data with other researchers who interested in this topic
Related trials for Fecal Incontinence in Children
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Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation
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Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study
Fecal Incontinence
Enrolling by invitationObservational study
Long-Term Health Outcomes in Children Born With Hirschsprung's Disease and Anorectal Malformations at the Colorectal Centre of Excellence in Quebec
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Not yet recruitingEarly Phase 1
Role of (Saline- Glycerin) Rectal Enema in Treatment of Fecal Incontinence in Children
Anorectal Malformation
Not yet recruiting
The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation
Refractory Constipation, Fecal Incontinence in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad M Abdelrahman, M.D. study director
Bnha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Treatment and Biofeedback in people with Fecal Incontinence in Children, run by Batterjee Medical College at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of incontinence episodes (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.