<?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>IRCT20240409061460N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-22</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of bladder botox and tamsulosin tablets in the treatment of symptomatic benign prostatic hyperplasia (BPH) patients.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of intravesical injection of Botox with oral tamsulosin 0.4 mg in the treatment of lower urinary tract symptom disorders (LUTS) in patients with symptomatic benign prostatic hyperplasia (BPH).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76422</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation is done by block method. 5 blocks of 8 are used.
In this way, the number of 5 blocks of 8 will be randomly extracted using WIN PEPI software. 8 compounds will be from two groups A (injection group) and group B (oral pill group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Benign prostatic hyperplasia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group will be injected with Botox in the bladder neck area.The way to inject Botox is that every 100 international units of Bo-A will be diluted in 2 ml of NT saline. The injection dose will be determined according to the prostate volume. For prostate volume less than 30 cc, between 30 and 60 cc and more than 60 cc, respectively, 100, 200 and 300 international units of BoNT-A under spinal anesthesia in the operation room will be injected in the neck area of ​​the bladder. Intervention 2: Control group: Patients in this group will be treated with tamsulosin 0.4 mg orally once a day.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dinyar Khazaeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Faculty of Medicine</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3373 8383</telephone>
        <email>khazaeli-d@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dinyar Khazaeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Faculty of Medicine</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3373 8383</telephone>
        <email>khazaeli-d@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Prostate volume more than 30 ml
2- Obtaining a score higher than 8 from the International Prostate Symptom Score (IPSS)
3- Serum level total prostate specific antigen (tPSA) less than 10ng/mL
4- maximum urinary flow rate (Qmax) less than 16 ml/s
5- Voided volume (VV) more than 150 ml</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>1- Having an active and recurrent urinary tract infection
2- History of previous prostatectomy
3- History of prostate cancer
4- Bladder or prostate stones
5- History of using phenylephrine, pseudoephedrine, imipramine, cholinergic, anticholinergic, estrogen, androgen and steroid since 4 weeks before the intervention
6- Biopsy from 6 weeks before the intervention
7- History of unstable angina pectoris, primary neurological disease that affects bladder function, such as multiple sclerosis, myasthenia gravis, Parkinson's
8- History of BoNT-A intraprostatic administration
9- Taking ASA, warfarin and NSAIDs from 6 days before the intervention
10- History of bladder sensitivity to BoNT-A</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D29.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign neoplasm of prostate</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: Patients in this group will be injected with Botox in the bladder neck area.The way to inject Botox is that every 100 international units of Bo-A will be diluted in 2 ml of NT saline. The injection dose will be determined according to the prostate volume. For prostate volume less than 30 cc, between 30 and 60 cc and more than 60 cc, respectively, 100, 200 and 300 international units of BoNT-A under spinal anesthesia in the operation room will be injected in the neck area of ​​the bladder.</i_keyword>
      <i_keyword>Control group: Patients in this group will be treated with tamsulosin 0.4 mg orally once a day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maximum urinary flow rate. Timepoint: Before and 3 months after the intervention. Method of measurement: Uroflowmetry test.</prim_outcome>
      <prim_outcome>Total Prostate Specific Antigen. Timepoint: Before and 3 months after the intervention. Method of measurement: ELISA test on blood sample.</prim_outcome>
      <prim_outcome>Prostate volume. Timepoint: Before and 3 months after the intervention. Method of measurement: Examination of ultrasound results.</prim_outcome>
      <prim_outcome>Prostate symptoms. Timepoint: Before and 3 months after the intervention. Method of measurement: International Prostate Symptom Score.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-06</approval_date>
        <contact_name>Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Ahvaz Academic City - Vice-Chancellor for Research and Technology, Jundishapur University of Medical Sciences and Healthcare Services, Ahvaz - ground floor Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
