<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20180714040466N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-09</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of electrical stimulation on fecal incontinence in children</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Posterior Tibial Nerve Electrical Stimulation with Conventional Treatments on Improving the Control of Functional Retentive Fecal Incontinence in Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/88040</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization as follows: Based on the number of patients in each group, the particular sort of treatment (the conventional treatment group and the posterior tibial nerve electrical stimulation group) is written on a piece of paper. Each paper is placed in a sealed envelope. One envelope will be chosen randomly by the therapist at the first session of the patient treatment and the patient's treatment technique is selected based on that. If any of the patients is omitted from the study, one envelope related to the excluded patient treatment group will be replaced and they will mixed again.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Functional Retentive Fecal Incontinence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the posterior tibial nerve stimulation group, patients will receive treatment three times per week for 8 weeks, for a total of 24 sessions. The procedure is performed with the patient lying in the supine position. The positive electrode is placed 1.5 inches above the medial malleolus, and the negative electrode is placed below the same malleolus. The current intensity is increased until flexion of the great toe and abduction of the other toes are observed, then reduced to a level at which the patient experiences only tingling or pins-and-needles sensation. Each treatment session lasts 20 minutes. Diaphragmatic breathing exercises, a daily bowel evacuation program, and adherence to a high-fiber diet will also be taught to the patients. Intervention 2: Control group: Patients in the routine treatment group will receive diaphragmatic breathing exercises, a daily bowel evacuation program, and adherence to a high-fiber diet three times per week for 8 weeks, for a total of 24 sessions.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No further information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Ghiasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam Al-Anbia Hops, Jame jam Blvd</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9815733169</zip>
        <telephone>+98 54 3322 0501</telephone>
        <email>f_ghiasi_p@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Ghiasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam Al-Anbia Hops, Jame jam Blvd</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9815733169</zip>
        <telephone>+98 54 3322 0501</telephone>
        <email>f_ghiasi_p@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 4 years
Having at least two of the Rome IV Criteria
Having been Under Drug Therapy and a Dietary Regimen for at least 3 months</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient's unwillingness to continue participation
Having any Organic Disease
Having a history of Intestinal Surgery
Having Urinary Incontinence Concomitant with Fecal Incontinence</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R15</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fecal incontinence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the posterior tibial nerve stimulation group, patients will receive treatment three times per week for 8 weeks, for a total of 24 sessions. The procedure is performed with the patient lying in the supine position. The positive electrode is placed 1.5 inches above the medial malleolus, and the negative electrode is placed below the same malleolus. The current intensity is increased until flexion of the great toe and abduction of the other toes are observed, then reduced to a level at which the patient experiences only tingling or pins-and-needles sensation. Each treatment session lasts 20 minutes. Diaphragmatic breathing exercises, a daily bowel evacuation program, and adherence to a high-fiber diet will also be taught to the patients.</i_keyword>
      <i_keyword>Control group: Patients in the routine treatment group will receive diaphragmatic breathing exercises, a daily bowel evacuation program, and adherence to a high-fiber diet three times per week for 8 weeks, for a total of 24 sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of fecal incontinence. Timepoint: Before and after the intervention. Method of measurement: Rintala questionnaire.</prim_outcome>
      <prim_outcome>Anal sphincter resting pressure. Timepoint: Before and after the intervention. Method of measurement: The pressure biofeedback.</prim_outcome>
      <prim_outcome>Maximum anal sphincter squeeze pressure. Timepoint: Before and after the intervention. Method of measurement: The pressure biofeedback.</prim_outcome>
      <prim_outcome>First rectal sensation. Timepoint: Before and after the intervention. Method of measurement: The pressure biofeedback.</prim_outcome>
      <prim_outcome>First urge of defecate. Timepoint: Before and after the intervention. Method of measurement: The pressure biofeedback.</prim_outcome>
      <prim_outcome>Strong urge to defecate. Timepoint: Before and after the intervention. Method of measurement: The pressure biofeedback.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-05-04</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Dr. Hesabi Square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
