<?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>IRCT2017050618760N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-27</date_registration>
      <primary_sponsor>Vice Chancellor for research of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of stabilization exercises focusing on pelvic floor on postnatal Stress urinary incontinence and low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of stabilization exercises focusing on pelvic floor on postnatal Stress urinary incontinence and low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16924</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 through Random Allocation software (RAS), Blinding description: Women's assessment at the beginning and end of the study will be conducted by a physiotherapist who is not present in the training process and is blind to women's allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Stress urinary incontinence. Condition 2: Low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: women participated in a 12-week program that involved performing a home based progressive stabilization exercises focusing on pelvic floor. The first session was for educating the correct contraction of transverse abdominis muscle using pressure biofeedback and PFM contraction using vaginal examination. Pamphlet and a video CD were given to all participants in this group and the exercises were monitored weekly through telephone interviews. Each week, permission to start new exercises was given only if the participant had no problem performing the previous exercise. Intervention 2: Control group: no treatment.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahime Khorasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz university of medical science, Tabriz, East Azarbayjan, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5157635411</zip>
        <telephone>+98 41 3331 1293</telephone>
        <email>Fahime_khorasani71@yahoo.com</email>
        <affiliation>Tabriz university of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fariba Ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valieasr, North Tavanir, school of rehabilitation</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5157635411</zip>
        <telephone>+98 33311392</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>Women who lived in Tabriz experienced stress urinary incontinence and back pain after 3-6 months of natural childbirth. The urinary incontinence and back pain of pregnancy are those that start during the pregnancy period or after the childbirth.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Caesarean section
urogenital diseases or infections
receive other treatments for SUI or LBP
history of pelvic floor or spinal surgeries
malignancies
pelvic or spinal fractures
having twins or multiple children
specific low back pain
severe urinary incontinence
LBP or UI before pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.3</hc_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress incontinence</hc_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: women participated in a 12-week program that involved performing a home based progressive stabilization exercises focusing on pelvic floor. The first session was for educating the correct contraction of transverse abdominis muscle using pressure biofeedback and PFM contraction using vaginal examination. Pamphlet and a video CD were given to all participants in this group and the exercises were monitored weekly through telephone interviews. Each week, permission to start new exercises was given only if the participant had no problem performing the previous exercise.</i_keyword>
      <i_keyword>Control group: no treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disability. Timepoint: Beginning and end of the study with an interval of 12 weeks. Method of measurement: Oswestry questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Beginning and end of the study with an interval of 12 weeks. Method of measurement: VAS scale.</prim_outcome>
      <prim_outcome>Intensity of stress urinary incontinence. Timepoint: Beginning and end of the study with an interval of 12 weeks. Method of measurement: Urinary incontinence questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Strength of pelvic floor muscles. Timepoint: Beginning and end of the study with an interval of 12 weeks. Method of measurement: Manual muscle testing.</sec_outcome>
      <sec_outcome>Endurance of pelvic floor muscles. Timepoint: Beginning and end of the study with an interval of 12 weeks. Method of measurement: Manual muscle testing.</sec_outcome>
      <sec_outcome>Strength of transverse abdominis. Timepoint: Beginning and end of the study with an interval of 12 weeks. Method of measurement: Pressure Biofeedback.</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>Vice Chancellor for research of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-24</approval_date>
        <contact_name>Ethics Committee of Vice Chancellor for Research of Tabriz University of Medical Science</contact_name>
        <contact_address>Tabriz, daneshgah square, tabriz university of medical science Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
