<?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>IRCT201012285486N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-01-28</date_registration>
      <primary_sponsor>Vice chancellor for research Tehran  university of medical sciences</primary_sponsor>
      <public_title>A comparative study of whole body vibration training and exercise therapy in treating females stress urinary incontinence</public_title>
      <acronym>WBVT &amp; Exercise therapy - SUI</acronym>
      <scientific_title>A comparative study of whole body vibration training and exercise therapy in treating females stress urinary incontinence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5887</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stress Urinary incontinence.</hc_freetext>
      <i_freetext>Intervention 1: Pelvic floor muscles strengthening exercises in the exercise therapy group. Intervention 2: Whole body vibration training  in WBVT group.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Objectives: To determine the effect of whole body vibration training program (WBVT) in comparison with exercise therapy (ET) program on stress urine incontinence.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Method: The study was designed as a randomized clinical trial. 43  women with SUI were randomly assigned in two groups; WBVT (21) and ET (22). All participants received either 10 sessions of WBVT or exercise therapy program under supervision.&lt;br /&gt;&#13;
Quality of life and incontinence intensity were evaluated by IQOL questionnaire and visual analogue score , Pelvic floor muscle (PFM) strength ,PFM static  and PFM dynamic were also evaluated  All measurements were conducted both pre and post intervention in all participants.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Results: It is obvious that both WBVT and ET methods are effective in management of SUI. This study showed the positive effects of exercise therapy and vibration training program in reducing the severity of incontinence, increasing IQOL questionnaire score, improvement of pelvic muscle strengths, the static and the dynamic tests of pelvic floor muscle in both groups. &lt;br /&gt;&#13;
We found significant difference in each groups pre and post intervention. (p= 0.000); but there was no significant difference in comparison of two groups' outcomes.&lt;br /&gt;&#13;
Conclusions: The findings of this study showed the beneficial effects of new exercise protocol and WBVT in improving the physical condition and quality of life in patients with urinary incontinence in 3 week treatment period.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Key Words: Stress Urinary Incontinence , Exercise therapy ,Whole body vibration training, Randomized clinical trial&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
           </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 Azar Moezy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sports Medicine department -Medical School-  Tehran university  of medical sceinces -Hemat Highway -</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8294 3424</telephone>
        <email>Moeziazr@sina.tums.ac.ir</email>
        <affiliation>Tehran university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Azar Moezy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sports Medicine department -Medical School-  Tehran university  of medical sceinces -Hemat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8294 3424</telephone>
        <email>moeziazr@sina.tums.ac.ir</email>
        <affiliation>TUMS</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: the development of genuine stress incontinence based on patient history, medical examination, a cotton-swab test urine culture; not being pregnant, breast feeding and menopause; age between 35 to 50 years; no history of exercise therapy for SUI in past 3 months; lack of neurological diseases such as MS, CVA, Spina bifida; no risk factor for pelvic visceral prolapse and outlet obstruction and detrusor instability; no high residual urine volume; no outlet obstruction and chronic constipation; lack of chronic disease, chronic respiratory disease; no contraindications for Vibration therapy and exercise therapy; no history of surgical treatment for incontinence; no history of pelvic cancers; no history of taking drugs that affect the urine; an read and write;&#13;
 Exclusion criteria: unwillingness of the patient for continuing the treatment sessions; pregnancy and diseases that may impede participation in the study; absence of patients in treatment sessions and genital and urinary infection;</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>50 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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Pelvic floor muscles strengthening exercises in the exercise therapy group</i_keyword>
      <i_keyword>Whole body vibration training  in WBVT group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urinary Incontinence. Timepoint: Before and after the intervention. Method of measurement: Assesment and examination.</prim_outcome>
      <prim_outcome>IQOL Questionnaire. Timepoint: Before and after the intervention. Method of measurement: IQOL Questionnaire score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pelvic floor muscle strength. Timepoint: Before and after the intervention. Method of measurement: The pelvic floor muscle strength and endurance with Manual Muscle Testing and completed questionnair.</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 Tehran  university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Ethics committe of vice chancellor for research ,Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Bluv Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
