<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04472923</url>
  </required_header>
  <id_info>
    <org_study_id>BatterjeeMC</org_study_id>
    <nct_id>NCT04472923</nct_id>
  </id_info>
  <brief_title>Biofeedback Training Fecal Incontinence in Children</brief_title>
  <official_title>Effect of Biofeedback Training on Functional Non-Retentive Fecal Incontinence in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Batterjee Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Batterjee Medical College</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fecal incontinence (FI) is the inability to control bowel movements, causing stool to leak&#xD;
      from rectum it ranges from an occasional leakage of stool while passing gas to a complete&#xD;
      loss of bowel control after the age of 4 years1. Functional non-retentive fecal incontinence&#xD;
      (FNRFI) is fecal incontinence in a child with a mental age of more than 4 years with no&#xD;
      evidence of metabolic, inflammatory, or anatomical cause2.&#xD;
&#xD;
      The long-term result of biofeedback therapy is one of the most important subjects of&#xD;
      controversy, and few studies have extended to 2 years of follow-up 11. So, the purpose of&#xD;
      this study was to evaluate quantitatively the short-term and long-term efficacy of&#xD;
      biofeedback training as a treatment tool designed to control functional non-retentive fecal&#xD;
      incontinence in children and its long term impact on the quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional non-retentive fecal incontinence (FNRFI) is fecal incontinence in a child with a&#xD;
      mental age of more than 4 years with no evidence of metabolic, inflammatory, or anatomical&#xD;
      cause2.&#xD;
&#xD;
      It is an extremely embarrassing and psychologically frustrating shameful problem with a bad&#xD;
      impact on children3. It can lead to social isolation, loss of self-confidence, depression,&#xD;
      and behavioral problems4. The underlying mechanism of functional non-retentive fecal&#xD;
      incontinence is largely unknown. The pathophysiology seems to be complex and it is considered&#xD;
      to be a multifactorial disorder5. Approximately 95% of the children had no organic cause and&#xD;
      these children are considered to have a functional defecation disorder. Of this, in&#xD;
      approximately 80% of these children FI is results of constipation and is treated with&#xD;
      laxatives, the remaining 20% without signs of fecal retention is classified as FNRFI6 The&#xD;
      negative psychological and social impact for these children is high, however, and requires&#xD;
      adequate intervention7. Biofeedback therapy is a feasible option that has been used for fecal&#xD;
      incontinence over several decades8. The underlying premise of biofeedback, as with learning&#xD;
      any physical activity, is that &quot;practice makes perfect&quot; if the learner is provided with&#xD;
      accurate feedback to make adjustments to optimize performance So, the purpose of this study&#xD;
      was to evaluate quantitatively the short-term and long-term efficacy of biofeedback training&#xD;
      as a treatment tool designed to control functional non-retentive fecal incontinence in&#xD;
      children and its long term impact on the quality of life.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The present study included 100 children of both sexes that were included with an age ranged&#xD;
      from (5-14 years) with FNRFI with normal bowel habits, normal defecation frequency, and&#xD;
      normal stool consistency with incontinence score ranging from 6-24 according to Vaizey score&#xD;
      12. Exclusion criteria included; children who have traumatic sphincter injury, fecal&#xD;
      impaction, spinal diseases causing incontinence, anorectal malformation, and children who&#xD;
      were not cooperative. Patients included in this study were randomly divided and allocated&#xD;
      into two groups Control group and Study group. Written informed consent was obtained from&#xD;
      parents of all included children.&#xD;
&#xD;
      A detailed history was taken including bowel habits, duration history of trauma. Complete&#xD;
      physical examination to exclude patients requiring surgical correction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2018</start_date>
  <completion_date type="Actual">July 5, 2020</completion_date>
  <primary_completion_date type="Actual">June 4, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.&#xD;
A detailed history was taken including bowel habits, duration history of trauma. Complete physical examination to exclude patients requiring surgical correction</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of incontinence episodes</measure>
    <time_frame>24 months</time_frame>
    <description>Change in the number of incontinence episodes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incontinence Score using Vaizey incontinence score</measure>
    <time_frame>24 months</time_frame>
    <description>Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fecal Incontinence Quality of life Score</measure>
    <time_frame>24 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting pressure (mm hg)</measure>
    <time_frame>3 months</time_frame>
    <description>Pressure during relaxation of the anal sphincter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Squeeze pressure (mm hg)</measure>
    <time_frame>3 months</time_frame>
    <description>Pressure during contraction of the anal sphincter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First sensation (volume of the balloon by cm water)</measure>
    <time_frame>3 months</time_frame>
    <description>First sensation of the stool in the rectum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First Urge (volume of the balloon by cm water)</measure>
    <time_frame>3 months</time_frame>
    <description>The patient is trying to hold defecation and he can</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intense urge (volume of the balloon by cm water)</measure>
    <time_frame>3 months</time_frame>
    <description>The Patent can no longer control the defecation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Fecal Incontinence in Children</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients belonging to the control group received conventional physical therapy program in the form of diet and Kegel exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traditional Treatment</intervention_name>
    <description>Patients belonging to the control group received conventional physical therapy program in the form of:&#xD;
Dietetic Regulation: The diet was given in the form of the bulk-forming diet, fruits, vegetables, cereals, and bran.&#xD;
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.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Diet and exercises</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biofeedback</intervention_name>
    <description>Patients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training.&#xD;
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.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ranged from (5-14 years) with FNRFI with normal bowel habits&#xD;
&#xD;
          -  Children with normal defecation frequency and normal stool consistency&#xD;
&#xD;
          -  Children with incontinence score ranging from 6-24 according to Vaizey score&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who have traumatic sphincter injury.&#xD;
&#xD;
          -  Children who have Fecal impaction&#xD;
&#xD;
          -  Children who have Spinal diseases causing incontinence&#xD;
&#xD;
          -  Children who have Anorectal malformation&#xD;
&#xD;
          -  Children who were not cooperative&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emad M Abdelrahman, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Bnha University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Benha University</name>
      <address>
        <city>Banhā</city>
        <state>Al Qalyubia Governorate</state>
        <zip>13511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 12, 2020</last_update_submitted>
  <last_update_submitted_qc>July 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Batterjee Medical College</investigator_affiliation>
    <investigator_full_name>Mohamed A. Abdel Ghafar</investigator_full_name>
    <investigator_title>Associate Professor of Physical Therapy</investigator_title>
  </responsible_party>
  <keyword>Fecal incontinence</keyword>
  <keyword>Biofeedback</keyword>
  <keyword>long-term</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After Publication, the investigators would like to share the data with other researchers who interested in this topic</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>After publication</ipd_time_frame>
    <ipd_access_criteria>Not available now</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04472923
org study id: BatterjeeMC
nct id: NCT04472923
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: Double (Participant, Outcomes Assessor)
measure: Number of incontinence episodes
time frame: 24 months
description: Change in the number of incontinence episodes
measure: Incontinence Score using Vaizey incontinence score
time frame: 24 months
description: Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
measure: Fecal Incontinence Quality of life Score
time frame: 24 months
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
measure: Resting pressure (mm hg)
time frame: 3 months
description: Pressure during relaxation of the anal sphincter
measure: Squeeze pressure (mm hg)
time frame: 3 months
description: Pressure during contraction of the anal sphincter
measure: First sensation (volume of the balloon by cm water)
time frame: 3 months
description: First sensation of the stool in the rectum
measure: First Urge (volume of the balloon by cm water)
time frame: 3 months
description: The patient is trying to hold defecation and he can
measure: Intense urge (volume of the balloon by cm water)
time frame: 3 months
description: The Patent can no longer control the defecation
arm group label: Control group
arm group type: Active Comparator
description: Patients belonging to the control group received conventional physical therapy program in the form of diet and Kegel exercises.
arm group label: Study group
arm group type: Experimental
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: Traditional Treatment
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.
arm group label: Control group
other name: Diet and exercises
intervention type: Device
intervention name: Biofeedback
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.
arm group label: Study group
criteria: 
gender: All
minimum age: 5 Years
maximum age: 14 Years
healthy volunteers: No
last name: Emad M Abdelrahman, M.D.
role: Study Director
affiliation: Bnha University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Batterjee Medical College
investigator full name: Mohamed A. Abdel Ghafar
investigator title: Associate Professor of Physical Therapy
mesh term: Fecal Incontinence
sharing ipd: Yes
ipd description: After Publication, the investigators would like to share the data with other researchers who interested in this topic
ipd info type: Study Protocol
ipd time frame: After publication
ipd access criteria: Not available now