<?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>IRCT20180305038956N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-17</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two prostatectomy methods</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of open  prostatectomy method  And classic TURP (Transurethral Resection of the Prostate)  in patients with prostate benign hyperplasia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30115</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using Sealed envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Benign prostate hyperplasia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At First, uroflowmetry is done for patients,Due to the size of the prostate and after cystoscopy, they undergo open prostatectomy on the same day. This is usually done with spinal anesthesia. Surgery with an incision at the bottom of the abdomen in the suprapubic area done. After removing the prostate, for the control of postoperative bleeding, a catheter is usually inserted into the bladder through the abdomen. After surgical procedure, Q-Max in uroflowmetry before and after surgery, urinary symptoms (obstruction and excitation) and postoperative complications such as bleeding, receiving blood during and after surgery, postoperative catheterization, wound infection , Urethral stricture and bladder neck and urinary retention in the period of one week, one month, three months and six months will be investigated. Intervention 2: Control group: At First, uroflowmetry is done for patients, Due to the size of the prostate and after cystoscopy, surgery for prostatectomy is performed by the TURP method (transurethral resection of the prostate). In this method, with spinal anesthesia, and by passing the camera into the urethral lumen, the part of the prostate that has caused the obstruction  completely clears and removes. After surgical procedure, Q-Max in uroflowmetry before and after surgery, urinary symptoms (obstruction and excitation) and postoperative complications such as bleeding, receiving blood during and after surgery, postoperative catheterization, wound infection , Urethral stricture and bladder neck and urinary retention in the period of one week, one month, three months and six months will be investigated.</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>Hormoz Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Urology , Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8913893111</zip>
        <telephone>+98 35 3626 0000</telephone>
        <email>h.karami@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hormoz Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Urology, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8913893111</zip>
        <telephone>+98 35 3626 0000</telephone>
        <email>h.karami@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The classical indications for prostate surgery
Patients with prostate size between 30 and 70 grams
Complete the informed consent form by the patient</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>80 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Previous prostate surgery with high PSA (Prostate Specific Antigen) Levels
Uncontrolled diabetes
History of CVA (cerebral vascular accident) and neurological diseases
Urinary tract obstruction
Addiction
Use of neurological and anticholinergic drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hyperplasia of prostate</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: At First, uroflowmetry is done for patients,Due to the size of the prostate and after cystoscopy, they undergo open prostatectomy on the same day. This is usually done with spinal anesthesia. Surgery with an incision at the bottom of the abdomen in the suprapubic area done. After removing the prostate, for the control of postoperative bleeding, a catheter is usually inserted into the bladder through the abdomen. After surgical procedure, Q-Max in uroflowmetry before and after surgery, urinary symptoms (obstruction and excitation) and postoperative complications such as bleeding, receiving blood during and after surgery, postoperative catheterization, wound infection , Urethral stricture and bladder neck and urinary retention in the period of one week, one month, three months and six months will be investigated.</i_keyword>
      <i_keyword>Control group: At First, uroflowmetry is done for patients, Due to the size of the prostate and after cystoscopy, surgery for prostatectomy is performed by the TURP method (transurethral resection of the prostate). In this method, with spinal anesthesia, and by passing the camera into the urethral lumen, the part of the prostate that has caused the obstruction  completely clears and removes. After surgical procedure, Q-Max in uroflowmetry before and after surgery, urinary symptoms (obstruction and excitation) and postoperative complications such as bleeding, receiving blood during and after surgery, postoperative catheterization, wound infection , Urethral stricture and bladder neck and urinary retention in the period of one week, one month, three months and six months will be investigated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Benign prostatic hyperplasia. Timepoint: One week after surgery, then one month, 3 months and 6 months after surgery. Method of measurement: The amount of Q-Max (Maximum urinary flow) in the uroflowmetry before and after the surgery.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bleeding. Timepoint: During surgery, up to a week later. Method of measurement: The rate of receiving blood during and after surgery, and expert examination.</sec_outcome>
      <sec_outcome>Wound infection. Timepoint: One week after surgery, then up to 1 month after surgery. Method of measurement: Expert examination.</sec_outcome>
      <sec_outcome>Duration of catheterization after surgery. Timepoint: 1,3,7 days after surgery. Method of measurement: Expert examination.</sec_outcome>
      <sec_outcome>Urethral stricture. Timepoint: 1 week, 1 month and 3 months after surgery. Method of measurement: Expert examination and retrograde urethrography.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-22</approval_date>
        <contact_name>Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Shahid Sadoughi University of Medical Sciences, Bahonar Sq,Yazd. Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
