<?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>IRCT20171021036916N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-17</date_registration>
      <primary_sponsor>Vice chancellor for research, Ahwaz JundiShapur University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Kegel exercise with and without Kegel Master device on the sexual function and  satisfaction in the middle-aged woman</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Kegel exercise with and without Kegel Master device on the sexual function and  satisfaction in the middle-aged woman</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28723</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study the subjects will be divided into two groups of 43, using block randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Female genital prolapsed. Condition 2: sexual function. Condition 3: Sexual satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Each participant should lie down on the back while bending her knee.then they will be asked to perform Kegel exercises without the device (including vaginal muscles contractions for 5-10 seconds with 5-10 seconds rest in between), three times a day for thirty times, for a total duration of 12 weeks. Intervention 2: Intervention group: The keglemaster device will buy from the ronas medicine company.The participant will be trained to open the device first and place the spring on the nearest place of the hinge. Then, The participant lies on the back while bending her knee, and slowly put the device in her vagina and opens it till it is completely fit. While doing the Kegel exercises, if no pressure was felt inside the vagina muscle, The participant need to relocate the spring and move it one step forward. the vaginal contraction should take 2 seconds. Each participant will do the kegel exercises with a keglemaster device in three sets every day with thirty repetitions each for twelve weeks.</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 There is Not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samane tafakh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Midwifery Department, Nursing &amp; Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1579461357</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>tafakh@ac.ajums.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Purandokht Afshari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Midwifery Department, Nursing &amp; Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1579461357</zip>
        <telephone>+98 61337338396</telephone>
        <email>pafshary@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Middle-aged woman
Permanent marriage
A score of 28 or less with a Prinometer
Normal urine culture</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Urogenital infection
Any systemic disorders
Addicted to drugs and alcohol
Experience of severe emotional stress within the previous three months
Physical or mental diseases affected on sexual function
Taking medicines affected on sexual function
Underlying medical diseases
Having urinary incontinence
mental or physical problems of husband affecting on couple sexual function</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N81</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female genital prolapse</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Each participant should lie down on the back while bending her knee.then they will be asked to perform Kegel exercises without the device (including vaginal muscles contractions for 5-10 seconds with 5-10 seconds rest in between), three times a day for thirty times, for a total duration of 12 weeks.</i_keyword>
      <i_keyword>Intervention group: The keglemaster device will buy from the ronas medicine company.The participant will be trained to open the device first and place the spring on the nearest place of the hinge. Then, The participant lies on the back while bending her knee, and slowly put the device in her vagina and opens it till it is completely fit. While doing the Kegel exercises, if no pressure was felt inside the vagina muscle, The participant need to relocate the spring and move it one step forward. the vaginal contraction should take 2 seconds. Each participant will do the kegel exercises with a keglemaster device in three sets every day with thirty repetitions each for twelve weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function. Timepoint: Before the intervention and after 3 months. Method of measurement: Standard questionnaire (FSFI).</prim_outcome>
      <prim_outcome>Sexual satisfaction. Timepoint: Before and 3 months after interventions. Method of measurement: Larson s standard sexual satisfaction questionarie.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pelvic floor muscles strength. 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>Vice chancellor for research, Ahwaz JundiShapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-21</approval_date>
        <contact_name>Ethical Committee of Ahvaz Jundishapur University of Medical Sciences.</contact_name>
        <contact_address>Ground Floor, Department of Research and Information Technology Jundishapur University of Medical Sciences, City University, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
