<?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>IRCT20190527043729N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-21</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>"Effect of Cupping Method in treatment of Urinary incontinence"</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Efficacy of Cupping Method on Urinary Incontinence in Women: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58677</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 76 Women with Urge or Mixed Urinary Incontinence referred to Farhagyan Clinic, Behbahan  University of Medical Sciences and Pelvic Floor Clinic of Imam Khomeini Hospital belongs to Tehran University of Medical Sciences,  During the year 1400 are available to study and each person is randomly assigned to one of two groups. The randomization method is simple and individual randomization unit. The tool used in randomization is Excel software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Urge Incontinence. Condition 2: Mixed Incontinence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group is treated with Static Hot Dry Cupping, With flaming alcohol cotton, a vacuum is created in each cup so that the cup sticks to the skin. The skin should protrude 2 to 3 cm into the cup. The cups are 45 mm in diameter. 4 to 6 cups, depending on the size of the person, are placed in two rows from below the navel to the pubic area and are kept for twenty minutes, twice a week, for 6 weeks. Intervention 2: Control group: patients will receive one tablet of 2 mg of tolterodine, Produced by Tehran Daru Pharmaceutical Company, twice a day, Intervention time is 6 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 no more information".</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Ghanbaryan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 27, Sarparast Ave., Taleghni St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8897 4535</telephone>
        <email>lghanbaryan@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malihe Tabarraie Arani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Traditional Medicine, Tehran University of Medical Sciences, Giti Alley, Vafamanesh Street, Heravi Square, Pasdaran Street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1668753961</zip>
        <telephone>+98 21 2298 8565</telephone>
        <email>dr.mtabarraie@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>30-70 Old Women with Urge or Mixed urinary Iincontinence; Being symptomatic for at least 3 months;
Not been treated for at least 2 week before study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Acute or Recurrent Urinary Tract Infection
Pregnancy or Lack of Contraception
Chronic Degenerative Neuromuscular Disease
Bladder Cancer or previous record of it
Pain of Bladder or Painful Urine Voiding
Record of Pelvic Surgery during past one year
Excessive Weight Loss
Uncontrolled Diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.41</hc_code>
      <hc_code>N39.46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Urge incontinence</hc_keyword>
      <hc_keyword>Mixed incontinence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group is treated with Static Hot Dry Cupping, With flaming alcohol cotton, a vacuum is created in each cup so that the cup sticks to the skin. The skin should protrude 2 to 3 cm into the cup. The cups are 45 mm in diameter. 4 to 6 cups, depending on the size of the person, are placed in two rows from below the navel to the pubic area and are kept for twenty minutes, twice a week, for 6 weeks.</i_keyword>
      <i_keyword>Control group: patients will receive one tablet of 2 mg of tolterodine, Produced by Tehran Daru Pharmaceutical Company, twice a day, Intervention time is 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency of urinary leakage. Timepoint: At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention. Method of measurement: International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire.</prim_outcome>
      <prim_outcome>The amount of urine leakage. Timepoint: At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention. Method of measurement: International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire.</prim_outcome>
      <prim_outcome>Time leakage: leakage befor sleep. Timepoint: At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention. Method of measurement: International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire.</prim_outcome>
      <prim_outcome>Time of leakage: leakage before reaching the bathroom. Timepoint: At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention. Method of measurement: International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire.</prim_outcome>
      <prim_outcome>Time leakage: leakage of urine with coughing and sneezing. Timepoint: At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention. Method of measurement: International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire.</prim_outcome>
      <prim_outcome>The leakage of urine: leakage of urine with exercise. Timepoint: At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention. Method of measurement: International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire.</prim_outcome>
      <prim_outcome>The leakage of urine: urine leakage after urination immediately prior to wearing underwear. Timepoint: At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention. Method of measurement: International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire.</prim_outcome>
      <prim_outcome>Assessment of changes in quality of life. Timepoint: At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention. Method of measurement: Incontinence Quality of Life (I-QOL) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Presumptive skin complications. Timepoint: 3 weeks after research start and 6 weeks after that (end of intervention). Method of measurement: Measurement form of drug complications According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-29</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>13 Floor, A Block, Headquarters of the Ministry of Health and Medical Education, Simayeiran Street, Between South Flamak and Zar Afshan Street, Qods Town, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
