<?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>IRCT20140811018760N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-15</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of tecar therapy with biofeedback on the treatment of fecal incontinence in children</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effects of tecar therapy with biofeedback in comparison with biofeedback alone on the treatment of fecal incontinence in children (4-16 years): a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>81</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69372</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by simple randomization method with table of random numbers  assigned to three groups, Blinding description: To hide the allocation of the type of intervention received, it will be written on a piece of paper and placed inside sealed envelopes, consecutively numbered. The envelopes will be opened in the order in which the participants enter the study and the type of group of people will be determined.
Due to the nature of the treatment, it is not possible to blind the patient and the researcher, so only the evaluator will be blind to the grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Children  fecal  incontinence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: biofeedback  therapy. Intervention 2: Intervention group 2: biofeedback  along with tecar therapy. Intervention 3: Control group: routine medical care.</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 Upon request, the desired journal will be sent in consultation with the authors.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariba Ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sciences ,Rehabilitation faculty</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 413339771</telephone>
        <email>ghaderimailbox@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sciences ,Rehabilitation faculty</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5167654455</zip>
        <telephone>+98 413339771</telephone>
        <email>ghaderimailbox@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age range of children is 4 to 16 years
Fecal incontinence for 6 months according to the diagnosis of the referring specialist</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children under 4 years old and over 16 years old
Traumatic sphincter injury or following surgery
Anorectal and anatomical abnormality of the excretory system or digestive system and sexual disorders
Psychological and psychiatric disorders
Understanding problems and children who are not able to cooperate with the physiotherapist for any reason.
Diseases of the spine or nerves that lead to fecal incontinence
Patients with sensory disorders in the anus and perineum</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F98.1</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>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: biofeedback  therapy</i_keyword>
      <i_keyword>Intervention group 2: biofeedback  along with tecar therapy</i_keyword>
      <i_keyword>Control group: routine medical care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of bowel incontinence per week. Timepoint: 6 weeks of treatment period, 6 weeks of follow-up. Method of measurement: Report of the patient or the child's parents.</prim_outcome>
      <prim_outcome>Severity of fecal incontinence. Timepoint: 6 weeks of treatment period,  6 weeks of follow-up. Method of measurement: Rintala   questionnaire.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: 6 weeks of treatment period, 6 weeks of follow-up. Method of measurement: Pediatrics Quality of life questionnaire for fecal incontinent.</prim_outcome>
      <prim_outcome>Severity of constipation. Timepoint: 6 weeks of treatment period,  6 weeks of follow-up. Method of measurement: Pediatrics constipation questionnaire.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-28</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
