<?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>IRCT20210925052576N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of Sildenafil and Tadalafil in the treatment of benign prostatic hyperplasia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Sildenafil and Tadalafil in the treatment of benign prostatic hyperplasia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58960</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: This study is uniquely designed as a single arm study with two consecutive interventions; each patient will be treated with Sildenafil for 6 weeks, then going through a 4 week washout period and lastly, they will be treated with Tadalafil for 6 weeks. The effectiveness of these regiments will be evaluated separately on each patient. Previous studies have shown that prostate size prior to treatment for BPH, profoundly affects the outcome of therapy; therefore, in order to eliminate this confounding factor; every patient will take both drug interventions in consecutive, separate stages and the results will be compared in order to establish the superior treatment choice.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Benign prostatic hyperplasia (BPH).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (first stage) : 50 milligram sildenafil tablet, nightly, for 6 weeks. Intervention 2: Intervention group( second stage) : 5 milligram tadalafil tablet, nightly, for 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
all data is shareable after undergoing a anonymity procedure with removal of patients name and surname.

When:
available from september 2022

To whom:
medical researchers

Conditions:
descriptive analysis is permitted.

Where to obtain:
email to: mazyar1995@gmail.com

How to obtain:
evaluation of the resume of the researcher who have asked for the data and emailing the files to them after making sure of their prior experience in medical research.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mazyar Zahir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohadaye Hesarak Blvd, Simon bolivar Blvd, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477899679</zip>
        <telephone>+98 21 4486 7262</telephone>
        <email>mazyar1995@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Samzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohadaye Hesarak Blvd, Simon bolivar Blvd, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477899679</zip>
        <telephone>+98 21 4486 7262</telephone>
        <email>o_samzadeh@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosed with Benign Prostatic Hyperplasia (BPH) with lower urinary tract symptoms(LUTS)
No prior history of other treatments in last month</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unwilling to take part in the study
Concurrent treatment with Nitrates
History of cardiac diseases or hypotension
History of prostate surgery
History of Lumbar discopathy or prior herniated disc surgery
History of extensive pelvic or perineal surgeries
Being a known case of neurogenic bladder or presence of its symptoms
Having an active urinary tract infection (UTI)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Enlarged prostate with lower urinary tract symptoms</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (first stage) : 50 milligram sildenafil tablet, nightly, for 6 weeks</i_keyword>
      <i_keyword>Intervention group( second stage) : 5 milligram tadalafil tablet, nightly, for 6 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-void residue (PVR). Timepoint: Measurement of post-void residue on first appointment( before treatment with sildenafil) and after 6 weeks (after treatment with sildenafil),  10 weeks( after washout period and before treatment with tadalafil) and 16 weeks( after treatment with tadalafil). Method of measurement: Bladder ultrasonography.</prim_outcome>
      <prim_outcome>International Prostate Symptom Score (IPSS). Timepoint: Calculation of International Prostate Symptom Score(IPSS) on first appointment( before treatment with sildenafil) and after 6 weeks (after treatment with sildenafil),  10 weeks( after washout period and before treatment with tadalafil) and 16 weeks( after treatment with tadalafil). Method of measurement: IPSS questionnaire.</prim_outcome>
      <prim_outcome>Initial prostate size. Timepoint: prior to treatment. Method of measurement: prostate ultrasonography.</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>hospital facilities</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-04</approval_date>
        <contact_name>Ethics committee of Islamic Azad University Tehran Medical Unit</contact_name>
        <contact_address>Gol-e-Yakh st, Ayeene blvd, Amir-pa-barja st, Shariati st, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
