<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/NCT04478799</url>
  </required_header>
  <id_info>
    <org_study_id>Banha University</org_study_id>
    <nct_id>NCT04478799</nct_id>
  </id_info>
  <brief_title>Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience</brief_title>
  <official_title>Long Term Outcome of Transcutaneous Posterior Tibial Nerve Stimulation in Treatment of Functional Non-Retentive Fecal Incontinence</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>
      Shafik and colleagues were the first to report the use of posterior tibial nerve stimulation&#xD;
      (PTNS) for FI, and they documented improved continence after 4 weeks course. Subsequent&#xD;
      studies documented percutaneous and transcutaneous PTNS as effective methods for treatment of&#xD;
      FI, with a short term reduction in incontinence episode by 50-80 %. Percutaneous PTNS (PPTNS)&#xD;
      showed a greater effect than transcutaneous PTNS (TPTNS) and this may be assumed due to the&#xD;
      presence of the stimulating electrode very close to the posterior tibial nerve. However,&#xD;
      TPTNS is more preferable to percutaneous PTNS because of the concern about the insertion of a&#xD;
      needle may result in stimulation that is sufficient to produce a neuromodulatory effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment of FNRFI is often difficult and requires prolonged therapies with unexpected&#xD;
      responses and frequent relapses. The corner-stones in treatment of FNRFI are education,&#xD;
      positive motivation, and toilet training. Preparation of children and their parents for a&#xD;
      long-lasting treatment is mandatory with the expectation of many ups and downs. The main goal&#xD;
      is to have regular bowel movements and normal continence and this can be achieved by teaching&#xD;
      the child the importance of regular toilet use and avoid urges.&#xD;
&#xD;
      Many previous studies, reported the short term effect of TPTNS in treatment of FNRFI.&#xD;
      However, there are sufficient studies evaluating the long term effect of TPNS and this has&#xD;
      motivated the authors to conduct of this study The aim of this study is to evaluate the Long&#xD;
      term outcome and quality of life in children with Functional non-retentive fecal incontinence&#xD;
      and received Bilateral Transcutaneous posterior tibial nerve stimulation therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 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 current single-blind randomized controlled study included 102 children with FNRF who were randomly allocated into two groups. Group 1, Bilateral transcutaneous posterior tibial nerve stimulation and group B, Sham TPTNS. Inclusion criteria included those with FI and normal defecation frequency, normal bowel habits and stool consistency. Children younger than 4 years or those who are not cooperative, or those with traumatic sphincter injury, fecal impaction, spinal diseases causing incontinence, anorectal malformation, were excluded from the study.</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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Group A (Transcutanous Posterior Tibial Nerve Stimulation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients belonging to the group A received Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (Sham Control)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients belonging to the group B received Sham Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutanous Posterior Tibial Nerve Stimulation</intervention_name>
    <description>children were managed by bilateral TPTNS following the procedure described in 2006 by Queralto et al(11). A positive auto-adhesive electrode was applied 1.5 inch above the medial malleolus over the S3 dermatome. A second negative electrode was applied just below the same malleolus. Electrical stimulation device (EMS physio Ltd, OX129 F, England) was connected to both electrodes. This device delivers a low frequency current (10 Hz), and the intensity was gradually increased till flexion of the big toe or spread out of the other toes in a fan shape occurred. Then the intensity was lowered to (10 Hz) again to avoid the motor response of the toes. Intensity was determined by the child's sensitivity. The procedure was done for 20-30 minutes and repeated2 times per week for 3 months</description>
    <arm_group_label>Group A (Transcutanous Posterior Tibial Nerve Stimulation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Transcutanous Posterior Tibial Nerve Stimulation</intervention_name>
    <description>Sham transcutaneous stimulation Patients also had twice-weekly 20-30-min sessions for 3 months. The same self-adhesive electrodes as used for group A were employed, placed in a similar position. The stimulator was briefly switched on for 30 s to induce only a minor electrical sensation in the skin, and was then turned off for the rest of the treatment. This short duration was given for only for a few seconds to avoid lower limb stimulation. Patients in all TWO groups were told that they may or may not have any perception of the electrical stimulation. Without prior knowledge of what to expect from treatment, this enabled the sham group to act as a control. In order to improve on the blinding effect of the study, the electronic display window of the stimulators was shielded from the patients in the TWO groups. All patients underwent therapy in individual screened cubicles to prevent comparison between patients of the treatment being administered.</description>
    <arm_group_label>Group B (Sham Control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ranged from (6-14 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 8-22 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>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed S Kharoub, MD</last_name>
    <role>Study Director</role>
    <affiliation>Faculty of Medicine- Benha 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 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 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</investigator_title>
  </responsible_party>
  <keyword>Posterior Tibial Nerve Stimulation</keyword>
  <keyword>Fecal Incontinence</keyword>
  <keyword>Long Term Effect</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, 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/NCT04478799
org study id: Banha University
nct id: NCT04478799
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Shafik and colleagues were the first to report the use of posterior tibial nerve stimulation
      (PTNS) for FI, and they documented improved continence after 4 weeks course. Subsequent
      studies documented percutaneous and transcutaneous PTNS as effective methods for treatment of
      FI, with a short term reduction in incontinence episode by 50-80 %. Percutaneous PTNS (PPTNS)
      showed a greater effect than transcutaneous PTNS (TPTNS) and this may be assumed due to the
      presence of the stimulating electrode very close to the posterior tibial nerve. However,
      TPTNS is more preferable to percutaneous PTNS because of the concern about the insertion of a
      needle may result in stimulation that is sufficient to produce a neuromodulatory effect.
Treatment of FNRFI is often difficult and requires prolonged therapies with unexpected
      responses and frequent relapses. The corner-stones in treatment of FNRFI are education,
      positive motivation, and toilet training. Preparation of children and their parents for a
      long-lasting treatment is mandatory with the expectation of many ups and downs. The main goal
      is to have regular bowel movements and normal continence and this can be achieved by teaching
      the child the importance of regular toilet use and avoid urges.

      Many previous studies, reported the short term effect of TPTNS in treatment of FNRFI.
      However, there are sufficient studies evaluating the long term effect of TPNS and this has
      motivated the authors to conduct of this study The aim of this study is to evaluate the Long
      term outcome and quality of life in children with Functional non-retentive fecal incontinence
      and received Bilateral Transcutaneous posterior tibial nerve stimulation therapy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The current single-blind randomized controlled study included 102 children with FNRF who were randomly allocated into two groups. Group 1, Bilateral transcutaneous posterior tibial nerve stimulation and group B, Sham TPTNS. Inclusion criteria included those with FI and normal defecation frequency, normal bowel habits and stool consistency. Children younger than 4 years or those who are not cooperative, or those with traumatic sphincter injury, fecal impaction, spinal diseases causing incontinence, anorectal malformation, were excluded from the study.
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
arm group label: Group A (Transcutanous Posterior Tibial Nerve Stimulation)
arm group type: Experimental
description: Patients belonging to the group A received Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises
arm group label: Group B (Sham Control)
arm group type: Sham Comparator
description: Patients belonging to the group B received Sham Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises
intervention type: Device
intervention name: Transcutanous Posterior Tibial Nerve Stimulation
description: children were managed by bilateral TPTNS following the procedure described in 2006 by Queralto et al(11). A positive auto-adhesive electrode was applied 1.5 inch above the medial malleolus over the S3 dermatome. A second negative electrode was applied just below the same malleolus. Electrical stimulation device (EMS physio Ltd, OX129 F, England) was connected to both electrodes. This device delivers a low frequency current (10 Hz), and the intensity was gradually increased till flexion of the big toe or spread out of the other toes in a fan shape occurred. Then the intensity was lowered to (10 Hz) again to avoid the motor response of the toes. Intensity was determined by the child's sensitivity. The procedure was done for 20-30 minutes and repeated2 times per week for 3 months
arm group label: Group A (Transcutanous Posterior Tibial Nerve Stimulation)
intervention type: Device
intervention name: Sham Transcutanous Posterior Tibial Nerve Stimulation
description: Sham transcutaneous stimulation Patients also had twice-weekly 20-30-min sessions for 3 months. The same self-adhesive electrodes as used for group A were employed, placed in a similar position. The stimulator was briefly switched on for 30 s to induce only a minor electrical sensation in the skin, and was then turned off for the rest of the treatment. This short duration was given for only for a few seconds to avoid lower limb stimulation. Patients in all TWO groups were told that they may or may not have any perception of the electrical stimulation. Without prior knowledge of what to expect from treatment, this enabled the sham group to act as a control. In order to improve on the blinding effect of the study, the electronic display window of the stimulators was shielded from the patients in the TWO groups. All patients underwent therapy in individual screened cubicles to prevent comparison between patients of the treatment being administered.
arm group label: Group B (Sham Control)
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: No
last name: Mohamed S Kharoub, MD
role: Study Director
affiliation: Faculty of Medicine- Benha 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
mesh term: Fecal Incontinence
sharing ipd: Yes
ipd description: After Publication, 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