<?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>IRCT2013113015597N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-19</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Tadalafil on Lower Urinary tract Symptoms of patients with ureteral stents</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effectiveness of Tadalafil versus placebo on lower urinary tract symptoms in male patients with ureteral stent, A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14824</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Tadalafil and placebo were packed by pharmacologist colleagues in similar packages of 35 identical numbers, and as A1, B2, B3, A4 ... were encoded. None of physicians, nurses, patients and statistical analyzers is aware of Coding method. The patients receive one of the packages randomly.</study_design>
      <phase>2-3</phase>
      <hc_freetext>LUTS associated with ureteral stents.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, tadalafil tablet (Chemidarou company) 10 mg once daily is given for 4 weeks by oral route. Intervention 2: In the control group, a placebo tablet (same shape, size and color of tadalafil which was made from starch by Pharmacy faculty of Tabriz University of Medical Sciences) is given for 4 weeks by oral route.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Abbas Jabbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Hospital, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5155969748</zip>
        <telephone>+98 41 1335 7328</telephone>
        <email>abbasjabbari@yahoo.com</email>
        <affiliation>Urology Department, Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sakineh Hajebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Hospital, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1334 7054</telephone>
        <email>hajebrahimis@gmail.com</email>
        <affiliation>Urology Department, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Male patients (+15 years) that underwent unilateral ureteral stenting. &#13;
Exclusion criteria: Patient's refusal of study; high blood pressure; history of heart disease; history of respiratory disease; history of stroke; hypotension (systolic blood pressure less than 90 mmHg); hepatic and renal failure; history of retinitis pigmentosa; severe headache; consumption of nitrate drugs and a positive urine culture</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>70 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R30-39</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>hematuria, dysuria, pain , urgency , frequency, incontinance</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, tadalafil tablet (Chemidarou company) 10 mg once daily is given for 4 weeks by oral route.</i_keyword>
      <i_keyword>In the control group, a placebo tablet (same shape, size and color of tadalafil which was made from starch by Pharmacy faculty of Tabriz University of Medical Sciences) is given for 4 weeks by oral route.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urinary symptoms (urgency; frequency; nocturia; dysuria; hematuria; incomplete emptying)  in patients with ureteral stents. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Standard questionnaire (USSQ).</prim_outcome>
      <prim_outcome>Abdominal pain, flank pain, inguinal and genital pain and pain severity and its association with physical activity, rest, voiding,… in patients with ureteral stent. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Standard questionnaire (USSQ).</prim_outcome>
      <prim_outcome>General health in patient with ureteral stent. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Standard questionnaire (USSQ).</prim_outcome>
      <prim_outcome>Sexual matters in patients with ureteral stent. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Standard questionnaire (USSQ).</prim_outcome>
      <prim_outcome>Work performance in patients with ureteral stent. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Standard questionnaire (USSQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cardiovascular side effects. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Musculoskeletal side effects. Timepoint: 4 Weeks after intervention (only at the end of study). Method of measurement: Questionnaire.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-09-11</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, Tabriz University of Medical Sciences, Daneshgah st, Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
