<?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>IRCT2017082218362N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-19</date_registration>
      <primary_sponsor>Ahvaz Jundishapur University of Medical Sciences, Vice Chancellor for Research Development and Techn</primary_sponsor>
      <public_title>Comparison of the Effects of Isolated Pelvic Floor Muscles Training, Deep Abdominal Muscles Training and Their Combination in Management of Stress Urinary Incontinence.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Isolated Pelvic Floor Muscles Training, Deep Abdominal Muscles Training and Their Combination in Quality of Life of Females with Stress Urinary Incontinence.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16673</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Table of random numbers will be used to simply assign the subjects in three groups of treatment. The examiner will not be aware of which intervention will be administered to which subject. The patients do not aware of other groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stress urinary incontinence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: Participants in the pelvic training group will be instructed to contract PFM .Vaginal palpation will be applied for the valid evaluation of vaginal squeeze pressure. Contraction of PFM will be progressed by positioning in: 1st session: crook; 2nd: supine; 3rd: side lying; 4th: sitting; 5th: standing; 6th, 7th: walking and last: ADL. Individuals will meet physiotherapist once a week to be instructed new exercise and physiotherapist will check exercises using telephone calls twice a week for 8 weeks. Participants will perform exercises 3 sets, 2 times a day .Each set contains  10 repetition of  isolated MVC of PFM as long as possible (maximum: 10 seconds) and 5 fast contraction(contraction: 1 second, rest:1second). Intervention 2: Intervention 2: Participants in the deep abdominal muscles training group will be instructed to contract Transversus Abdominis. Contraction of TrA will be progressed by positioning in: 1st session: crook; 2nd: crook with flexion and extension of knee; 3rd: crook with flexion and extension of shoulder; 4th: sitting; 5th: standing; 6th, 7th: walking and last: ADL. Individuals will meet physiotherapist once a week to be instructed new exercise and physiotherapist will check exercises using telephone calls twice a week for 8 weeks. Participants will perform exercises 3 sets, 2 times a day .Each set contains  10 repetition of  isolated maximum voluntary contraction of TrA as long as possible (maximum: 10 seconds) and 5 fast contraction (contraction: 1 second, rest:1second ). Intervention 3: Intervention 3 : Participants in the combination of pelvic and abdominal muscles training group will be instructed to contract PFM and TrA. Vaginal palpation will be applied for the evaluation of vaginal squeeze pressure. Cocontraction of PFM and TrA will be progressed by positioning in: 1st session: crook; 2nd: supine; 3rd: side lying; 4th: sitting; 5th: standing; 6th, 7th: walking and last: ADL. Individuals will meet physiotherapist once a week to be instructed new exercise and physiotherapist will check exercises using telephone calls twice a week for 8 weeks. Participants will perform exercises 3 sets, 2 times a day .Each set contains  10 repetition of  isolated maximum voluntary Cocontraction of PFM and TrA  as long as possible (maximum: 10 seconds) and 5 fast contraction (contraction: 1 second, rest:1second ).</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>Dr. Fateme Esfandiarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, University Pardis, Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3374 3108</telephone>
        <email>esfandiarpour_f@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fateme Esfandiarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, University Pardis, Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3374 3108</telephone>
        <email>esfandiarpour_f@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Females with SUI in the age range of 18-60 years will be included in this study if they have complaint of involuntary leakage of urine on effort or on sneezing or coughing. Exclusion Criteria: Subjects will be excluded if they have a history of surgery involving the pelvic floor; neurological or psychiatric disease or a major medical condition; current pregnancy or less than 3 months postpartum; prolapse; severe low back pain or pelvic pain; ongoing urinary tract infections and undergoing concurrent treatment for SUI.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress incontinence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: Participants in the pelvic training group will be instructed to contract PFM .Vaginal palpation will be applied for the valid evaluation of vaginal squeeze pressure. Contraction of PFM will be progressed by positioning in: 1st session: crook; 2nd: supine; 3rd: side lying; 4th: sitting; 5th: standing; 6th, 7th: walking and last: ADL. Individuals will meet physiotherapist once a week to be instructed new exercise and physiotherapist will check exercises using telephone calls twice a week for 8 weeks. Participants will perform exercises 3 sets, 2 times a day .Each set contains  10 repetition of  isolated MVC of PFM as long as possible (maximum: 10 seconds) and 5 fast contraction(contraction: 1 second, rest:1second).</i_keyword>
      <i_keyword>Intervention 2: Participants in the deep abdominal muscles training group will be instructed to contract Transversus Abdominis. Contraction of TrA will be progressed by positioning in: 1st session: crook; 2nd: crook with flexion and extension of knee; 3rd: crook with flexion and extension of shoulder; 4th: sitting; 5th: standing; 6th, 7th: walking and last: ADL. Individuals will meet physiotherapist once a week to be instructed new exercise and physiotherapist will check exercises using telephone calls twice a week for 8 weeks. Participants will perform exercises 3 sets, 2 times a day .Each set contains  10 repetition of  isolated maximum voluntary contraction of TrA as long as possible (maximum: 10 seconds) and 5 fast contraction (contraction: 1 second, rest:1second ).</i_keyword>
      <i_keyword>Intervention 3 : Participants in the combination of pelvic and abdominal muscles training group will be instructed to contract PFM and TrA. Vaginal palpation will be applied for the evaluation of vaginal squeeze pressure. Cocontraction of PFM and TrA will be progressed by positioning in: 1st session: crook; 2nd: supine; 3rd: side lying; 4th: sitting; 5th: standing; 6th, 7th: walking and last: ADL. Individuals will meet physiotherapist once a week to be instructed new exercise and physiotherapist will check exercises using telephone calls twice a week for 8 weeks. Participants will perform exercises 3 sets, 2 times a day .Each set contains  10 repetition of  isolated maximum voluntary Cocontraction of PFM and TrA  as long as possible (maximum: 10 seconds) and 5 fast contraction (contraction: 1 second, rest:1second ).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Incontinence Quality of Life Questionnaire scale. Timepoint: Before and after treatment interventions. Method of measurement: Incontinence Quality of Life Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maximal voluntary contraction of  pelvic floor muscles. Timepoint: Before and post treatment intervention. Method of measurement: perinometer.</sec_outcome>
      <sec_outcome>Endurance of  pelvic floor muscles. Timepoint: Before and post treatment intervention. Method of measurement: perinometer.</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>Ahvaz Jundishapur University of Medical Sciences, Vice Chancellor for Research Development and Techn</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-22</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Central Office, University Campus, Golestan Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
