<?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>IRCT20181204041841N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-16</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise on urinary incontinence</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect  of Swiss ball and Kegel exercise on pelvic floor muscles  strength  and severity of  urinary incontinence in women with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35875</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 56 women with MS and urinary incontinence will be selected based on inclusion criteria. All of the patients are randomly assigned  to one of the following two groups according to a computer-generated randomization list: G1 Swiss ball (n=28 ) and G2 Kegel  exercise (n=28), Blinding description: It is a single- blind study. In this study, the researcher after   obtaining informed consent from the patients, will design two intervention groups for them.These two groups are:   G1(Swiss ball) and G2(Kegel exercise), So 56 MS patients with urinary incontinence are randomly assigned to one of two groups and all of the patients are blind to the randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the Swiss ball group will perform pelvic floor muscle exercises with assistance of Swiss ball  and in the rehabilitation clinic of Ahvaz University of Medical Sciences under the supervision of the researcher. These exercises will be performed three times per week for 12 weeks and each session lasts 45 minutes. All patients are evaluated and compared before the intervention and at the end of the third month. These evaluations are include: Pelvic floor muscles testing (By Prenometer) and ICIQ- UI SF questionnaire completion. Intervention 2: Control group: In the Kegel group, the patients will be trained how to perform pelvic floor muscle exercises. These exercises are include: sleeping on the back with bended knees, Sitting and standing and will be done at home. These contractions start at 3 seconds and gradually takes up to 10 seconds. These exercises are performed three times per day for 12 consecutive weeks.  All patients are evaluated and compared before the intervention and at the end of the third month. These evaluations are include: Pelvic floor muscles testing (By Prenometer) and ICIQ- UI SF questionnaire completion.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nosrat Zaheryan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of Nursing and Midwifery, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3446 2503</telephone>
        <email>zaheryan_n@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nosrat Zaheryan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of Nursing and Midwifery, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3446 2503</telephone>
        <email>zaheryan_n@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>women with definitive diagnosis of MS
Have symptoms of urinary incontinence
Expanded disability status scale (EDSS) score less than 5(According to the diagnosis of the neurologist)
Being married
18-45 years of age
Relapsing--remitting form of MS
No history of cesarean section or vaginal delivery during the last 6 months
Having the reading and writing literacy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Severe cognitive problems
MS attack relapsed over the past three months
pregnancy
Use diuretics and hypotensive drugs
postmenopausal
urinary tract infection
history of diabetes
Having fatigue too(increased muscle weakness)
pelvic organ prolapse and previous gynecological surgery
BMI Above 30</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the Swiss ball group will perform pelvic floor muscle exercises with assistance of Swiss ball  and in the rehabilitation clinic of Ahvaz University of Medical Sciences under the supervision of the researcher. These exercises will be performed three times per week for 12 weeks and each session lasts 45 minutes. All patients are evaluated and compared before the intervention and at the end of the third month. These evaluations are include: Pelvic floor muscles testing (By Prenometer) and ICIQ- UI SF questionnaire completion.</i_keyword>
      <i_keyword>Control group: In the Kegel group, the patients will be trained how to perform pelvic floor muscle exercises. These exercises are include: sleeping on the back with bended knees, Sitting and standing and will be done at home. These contractions start at 3 seconds and gradually takes up to 10 seconds. These exercises are performed three times per day for 12 consecutive weeks.  All patients are evaluated and compared before the intervention and at the end of the third month. These evaluations are include: Pelvic floor muscles testing (By Prenometer) and ICIQ- UI SF questionnaire completion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pelvic floor muscles strength. Timepoint: Before the start of the intervention and 12 weeks after the beginning of the exercises. Method of measurement: Perineometer.</prim_outcome>
      <prim_outcome>Urinary incontinence. Timepoint: Before the start of the intervention and 12 weeks after the  beginning of the exercises. Method of measurement: ICIQ - UI SF questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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 University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-01</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University Of Medical Sciences and  Health Services</contact_name>
        <contact_address>Ahvaz Jundishapur University Of Medical Sciences and Health Services,Golestan Blvd, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
