<?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>IRCT20230113057119N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-04</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of yoga training program on pelvic floor muscle strength, bladder neck descent,urinary control, urogenital hiatus diameter and urethral rotation angles in female athletes with stress urinary incontinence due to training intensity.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of yoga training program on pelvic floor muscle strength, bladder neck descent,urinary control, urogenital hiatus diameter and urethral rotation angles in female athletes with stress urinary incontinence due to training intensity.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68047</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random - lottery (in this method, the researcher gives a code or a special number to each member of the society. Then he writes down the number of each of them on a piece of paper, then he pours them into a container and shakes them. Then the papers are separated one by one. take them out, write down their numbers and divide them into experimental and control groups).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stress Urinary Incontinence (SUI).</hc_freetext>
      <i_freetext>Intervention 1: Intervention: Yoga exercises group. After checking the records and evaluation using the form to collect information such as age, sports history, pregnancy history, disease history and drug use, etc and the international form of urinary incontinence from the patients,10 people will be selected with stress urinary incontinence. Then these people will be invited by signing the consent form. until the pre-test (quality of life questionnaire, two-dimensional ultrasound of pelvic floor muscles and clinical assessment of vaginal touch) and after the implementation of yoga rehabilitation exercise program to strengthen pelvic floor muscles and core muscles and breathing exercises for eight weeks in three sessions An hour and a quarter per week and in each session, a post-test (quality of life questionnaire, two-dimensional ultrasound of the pelvic floor muscles and clinical assessment of vaginal palpation) is performed. Intervention 2: Intervention: Yoga exercises group. After checking the records and evaluation using the form to collect information such as age, sports history, pregnancy history, disease history and drug use, etc and the international form of urinary incontinence from the patients,10 people will be selected with stress urinary incontinence. Then these people will be invited by signing the consent form. until the pre-test (quality of life questionnaire, two-dimensional ultrasound of pelvic floor muscles and clinical assessment of vaginal touch) and in these four weeks he continued with his routine activities and finally  a post-test (quality of life questionnaire, two-dimensional ultrasound of the pelvic floor muscles and clinical assessment of vaginal palpation) is performed.</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 The information about the subjects is personal and will not be shared with others.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariborz Hovanlo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Sport and Health Sciences, Shahid Beheshti Univercity, Shahid Dr , Shahriari Square (Univercity Square), Rashiduddin Fazlulla St.,Yaman St., Velenjak,Chamran Highway,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 5821</telephone>
        <email>f_hovanloo@sbu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariborz Hovanlo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Sport and Health Sciences, Shahid Beheshti Univercity, Shahid Dr , Shahriari Square (Univercity Square), Rashiduddin Fazlulla St.,Yaman St., Velenjak,Chamran Highway,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 5821</telephone>
        <email>f_hovanloo@sbu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>be a woman
Suffering from stress urinary incontinence
Sports history
Have not done yoga for at least six months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having diabetes
Lack of cooperation
smoking
urinary tract infection
hormonal drugs
Menopause
high BMI
taking contraceptives
eating disorders
pregnancy less than ten years and more than twice
history of pelvic floor surgery in the previous year
pelvic pain in digital examination</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress incontinence (female) (male)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention: Yoga exercises group. After checking the records and evaluation using the form to collect information such as age, sports history, pregnancy history, disease history and drug use, etc and the international form of urinary incontinence from the patients,10 people will be selected with stress urinary incontinence. Then these people will be invited by signing the consent form. until the pre-test (quality of life questionnaire, two-dimensional ultrasound of pelvic floor muscles and clinical assessment of vaginal touch) and after the implementation of yoga rehabilitation exercise program to strengthen pelvic floor muscles and core muscles and breathing exercises for eight weeks in three sessions An hour and a quarter per week and in each session, a post-test (quality of life questionnaire, two-dimensional ultrasound of the pelvic floor muscles and clinical assessment of vaginal palpation) is performed.</i_keyword>
      <i_keyword>Intervention: Yoga exercises group. After checking the records and evaluation using the form to collect information such as age, sports history, pregnancy history, disease history and drug use, etc and the international form of urinary incontinence from the patients,10 people will be selected with stress urinary incontinence. Then these people will be invited by signing the consent form. until the pre-test (quality of life questionnaire, two-dimensional ultrasound of pelvic floor muscles and clinical assessment of vaginal touch) and in these four weeks he continued with his routine activities and finally  a post-test (quality of life questionnaire, two-dimensional ultrasound of the pelvic floor muscles and clinical assessment of vaginal palpation) is performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urinary Incontinence. Timepoint: Before eight weeks of yoga and after eight weeks of yoga. Method of measurement: Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Urinary Incontinence Quality Of Life. Timepoint: Before and after eight weeks of yoga. Method of measurement: Incontinence Quality Of Life(IQOL).</sec_outcome>
      <sec_outcome>Bladder neck descent. Timepoint: Before and after eight weeks of yoga. Method of measurement: Ultrasound.</sec_outcome>
      <sec_outcome>The diameter of the urogenital hiatus. Timepoint: Before and after eight weeks of yoga. Method of measurement: Ultrasound.</sec_outcome>
      <sec_outcome>Pelvic floor muscle strength. Timepoint: Before and after eight weeks of yoga. Method of measurement: Vaginal touch clinical test.</sec_outcome>
      <sec_outcome>Angles of rotation of the urethra. Timepoint: Before and after eight weeks of yoga. Method of measurement: Ultrasound.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-12</approval_date>
        <contact_name>Shahid Beheshti University</contact_name>
        <contact_address>Unit 1 , East First Floor , NO 32,Moosavi Alley , South Kerman Sq , Qassem Soleimani Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
