<?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>IRCT2015011020011N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-10</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of patients with dyssynergic defecation after biofeedback therapy  by MR defecography</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of pelvic motion in  patients with chronic constipation due to dyssynergic defecation after biofeedback therapy  by MR defecography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17761</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic costipation and dyssynergic defecation.</hc_freetext>
      <i_freetext>Intervention 1: For control group; standard therapy [The instructions regarding bowel habit, daily exercise (walking for 20 minutes), diaphragmatic breathing exercises (daily for 15 minutes, three times a day), dietary fiber and fluid intake, toilet timing (the patient was taught to attempt having a bowel movement at least twice a day, 30 minutes after meals or walking and consulted to avoid straining more than 5 minutes during defecation). If patients had no bowel movement for more than 48 hours, they were guided to use laxatives, such as polyethylene glycol. The patients were trained about the correct position of defecation. The duration is 3 months and the patients were supervised at least once a week over phone], cognitive-behavioral therapy (once a week). Intervention 2: For experimental group; biofeedback therapy(to correct the dyssynergic pattern of defecation, the patients should learn how to appropriately contract or relax anal and pelvic floor muscles, by visual and verbal feedback. A surface electrode on abdominal muscles and an interarectal pressure probe are used to monitor the activity of the muscles. Each biofeedback therapy session is performed 60 minutes twice a week for 12 sessions, then, once a week for 6 sessions, as a whole 18 sessions over 3 months.), exercise therapy ( three times a day for ten minute), cognitive-behavioral therapy (once a week) and standard therapy .</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afsaneh Nikjooy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madadkaran; Shahnazari Av.; Madar Sq.; Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>afsanehnikjooy@yahoo.com; maroufi.n@iums.ac.ir</email>
        <affiliation>Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afsaneh Nikjooy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madadkaran  St.; Shahnazari Av.; Madar Sq.;Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>afsanehnikjooy@yahoo.com; maroufi.n@iums.ac.ir;</email>
        <affiliation>Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The Patients participate in this study, with chronic constipation who fulfill “ Rome diagnostic criteria” for functional constipation for at least 12 weeks: they need to strain in defecation, have lumpy or hard stools, sensation of incomplete evacuation, and need manual maneuvers to facilitate defecation in more than 1/4 of bowel movements. They have a dyssynergic pattern of defecation. The patients also have diagnostic testing evidence (anorectal manometry or defecography or balloon expulsion test) of dyssynergic defecation. The diagnosis of paradoxical contraction of puborectalis muscle during straining is established by digital rectal examination. Patients were excluded from the study if they had previous anorectal surgery, anorectal tumors, or structural anorectal disorders, which needed operation intervention. Other exclusion criteria were significant cardiovascular, respiratory, neurologic, psychiatric illnesses, sever psychological problems, or endocrine and metabolic diseases that could cause constipation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorder of muscle, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For control group; standard therapy [The instructions regarding bowel habit, daily exercise (walking for 20 minutes), diaphragmatic breathing exercises (daily for 15 minutes, three times a day), dietary fiber and fluid intake, toilet timing (the patient was taught to attempt having a bowel movement at least twice a day, 30 minutes after meals or walking and consulted to avoid straining more than 5 minutes during defecation). If patients had no bowel movement for more than 48 hours, they were guided to use laxatives, such as polyethylene glycol. The patients were trained about the correct position of defecation. The duration is 3 months and the patients were supervised at least once a week over phone], cognitive-behavioral therapy (once a week).</i_keyword>
      <i_keyword>For experimental group; biofeedback therapy(to correct the dyssynergic pattern of defecation, the patients should learn how to appropriately contract or relax anal and pelvic floor muscles, by visual and verbal feedback. A surface electrode on abdominal muscles and an interarectal pressure probe are used to monitor the activity of the muscles. Each biofeedback therapy session is performed 60 minutes twice a week for 12 sessions, then, once a week for 6 sessions, as a whole 18 sessions over 3 months.), exercise therapy ( three times a day for ten minute), cognitive-behavioral therapy (once a week) and standard therapy .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Muscle function((Paradox index &amp; perinal descend index ). Timepoint: before treatment and after its completion (3 months). Method of measurement: MR defecography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Symptomatic changes. Timepoint: before tretment and after its completion. Method of measurement: costipation scoring questionnaire.</sec_outcome>
      <sec_outcome>The quality of life. Timepoint: before tretment and after its completion. Method of measurement: the culturally adapted version of Short Form-36.</sec_outcome>
      <sec_outcome>Severity of depression. Timepoint: before tretment and after its completion. Method of measurement: , the culturally adapted version of Beck Depression Inventory questionnaires.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-16</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Blvd.; Tehran University of Medical Sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
