<?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>IRCT20190909044734N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-21</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of magnet therapy on the improvement of urinary incontinence</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of magnetic therapy on the improvement of stress urinary incontinency in obese women referred to Ghadir mother and child hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42326</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Volunteer patients were randomly assigned to one of two intervention or control groups with blocked randomization method. six blocks with the size of four were considered and 12 subjects were placed in each group, Blinding description: Patients were aware of the second group at the time of filling out the informed consent form and were therefore not blind to the groups. The therapists were also aware of both groups and types of treatment, and the just the  person who evaluate the patients was completely blind to the groups and treatment received, and the data were also analyzed by someone who was completely blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pelvic floor disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They received magnet therapy and pelvic floor exercises. Intervention 2: Control group:They only received pelvic floor exercises.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty, Abiverdi 1 st, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194733669</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>leabbasi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation, Chamran Boulevard, 1 Abivardi Ave.  Learn to pronounce</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194733669</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>leabbasi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women 21 years and older
with similar number of deliveries
with stress urinary incontinence
Body mass index in the range of 30-35
Lack of neurological diseases such as multiple sclerosis.
Lack of sensory and motor disorders.
Lack of mental illnesses (preventing proper communication and understanding)
no musculoskeletal disorders.
presence of urine leakage during coughing
urine leakage of about 200-250 ml.
incontinence questionnaire score Urine and quality of life should be at least 6 (normal is 21).
Ability to perform pad test
The patient should participate in the study voluntarily and by signing the consent form.</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People with other types of urinary incontinence  such as urgent urinary incontinence, functional urinary incontinence, mixed urinary incontinence.
History of any heart failure and illness such as severe cardiac arrhythmia
hypertension.
Pacemaker and metal In the body
Acute infection
Malignancy
Pregnancy or try for pregnancy
Surgery to treat stress urinary incontinence.
Vaginal bleeding
History of pelvic surgery between 3-8 weeks ago
History of pelvic radiation
Having Pelvic ulcer or burn.
History of medication for urinary incontinence in the past three months such as alpha-adrenergic, diuretic, serotonin, epinephrine.
High blood sugar glucose 100mmol / lit</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 group: They received magnet therapy and pelvic floor exercises</i_keyword>
      <i_keyword>Control group:They only received pelvic floor exercises</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The quality of life questionnaire,. Timepoint: Before the intervention and treatment of the eighth session and one month after the last treatment session. Method of measurement: I-QOL questionnaire.</prim_outcome>
      <prim_outcome>Urinary incontinence intensity,. Timepoint: Before the intervention and treatment of the eighth session and one month after the last treatment session. Method of measurement: By determining the amount of urine absorbed in the pad.</prim_outcome>
      <prim_outcome>Urinary incontinence frequency,. Timepoint: Before the intervention and treatment of the eighth session and one month after the last treatment session. Method of measurement: Using the patient self report.</prim_outcome>
      <prim_outcome>Urine frequency,. Timepoint: Before the intervention and treatment of the eighth session and one month after the last treatment session. Method of measurement: Using the patient self report.</prim_outcome>
      <prim_outcome>Delivery frequency,. Timepoint: Before the intervention and treatment of the eighth session and one month after the last treatment session. Method of measurement: Using the patient self report.</prim_outcome>
      <prim_outcome>BMI. Timepoint: Before the intervention and treatment of the eighth session and one month after the last treatment session. Method of measurement: using BMI index.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-17</approval_date>
        <contact_name>Ethics committee of research of Shiraz Faculty of Rehabilitation Sciences</contact_name>
        <contact_address>Abyvardi 1 Street. Chamran Blvd. shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
