<?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>IRCT20201225049827N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-16</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Clinical Efficacy of Transurethral Resection of the Prostate Combined with Oral Anticholinergics or Botulinum Toxin–A Injection to Treat Benign Prostatic Hyperplasia with Overactive Bladder, Randomized Clinical Trial Study</public_title>
      <acronym></acronym>
      <scientific_title>Clinical Efficacy of Transurethral Resection of the Prostate Combined with Oral Anticholinergics or Botulinum Toxin–A Injection to Treat Benign Prostatic Hyperplasia with Overactive Bladder, Randomized Clinical Trial Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53817</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who meet the inclusion criteria are simply randomized by computer software at the time of admission by someone who is not aware of the interventions. They are divided into two groups. Then an envelope containing the type of intervention that is not clear will be given to them and they will be referred to the operating room, Blinding description: The principal investigator, the health care personnel (physicians, nurses) who are responsible for patient care, the data collectors, and those who evaluate the outcome are blind and unaware of the patient's treatment process.
The Data Protection and Supervision Committee is not aware.</study_design>
      <phase>3</phase>
      <hc_freetext>LUTS In patients with benign prostatic hyperplasia.</hc_freetext>
      <i_freetext>Intervention 1: Disport Botox injection of 300 mg diluted with 10 cc of normal saline is injected into the bladder detrusor once after transurethral resection of the prostate. Intervention 2: Control group: One month after transurethral resection of the prostate, they are treated with oral sulifenacin (vesicare 5mg) at a dose of 5 mg daily for 6 months.</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>Seyed Farzad Allame</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada-e-Tajrish Hospital, Shahrdary Street. Tajrish Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 2271 8003</telephone>
        <email>farzadallame@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Farzad Allame</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada-e-Tajrish Hospital, Shahrdary Street. Tajrish Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 2271 8003</telephone>
        <email>farzadallame@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obstructive symptoms of urinary obstruction defined by IPSS and enlarged prostate on DRE examination
Consent to enter the study
Existence of LUTS symptoms
OAB and DO approval with biodynamics and Eurodynamics study</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>84 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Patients with neurological diseases such as Parkinson's or stroke
Prostate or bladder cancer
People who have had bladder or prostate surgery in the past
Dissatisfaction with enrollment
Allergy to sulifenacin or Botox</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z87.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Personal history of diseases of genitourinary system</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>Disport Botox injection of 300 mg diluted with 10 cc of normal saline is injected into the bladder detrusor once after transurethral resection of the prostate.</i_keyword>
      <i_keyword>Control group: One month after transurethral resection of the prostate, they are treated with oral sulifenacin (vesicare 5mg) at a dose of 5 mg daily for 6 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>IPSS(International Prostate Score System) in two groups of botulinum and sulifenacin injection after TURP(Trans Urethral Resection Of Prostate) at 1, 3 and 6 months after treatment. Timepoint: 1, 3 and 6 months after transurethral resection of the prostate are checked. Method of measurement: Based on the International Index of Prostate Symptoms.</prim_outcome>
      <prim_outcome>Urgent incontinence in the two groups of botulinum and sulifenacin injections after TURP(International Prostate Score System) is performed at 1, 3 and 6 months after treatment. Timepoint: 1, 3 and 6 months after transurethral resection of the prostate are checked. Method of measurement: It is done based on the patient's question.</prim_outcome>
      <prim_outcome>Prostate volume in the two treatment groups of botulinum and sulifenacin injection after TURP(International Prostate Score System) is done at 1, 3 and 6 months after treatment. Timepoint: 1, 3 and 6 months after transurethral resection of the prostate are checked. Method of measurement: It is done based on ultrasound.</prim_outcome>
      <prim_outcome>PVR(Post Voiding Residue) is performed in two treatment groups botulinum and sulifenacin injection after TURP(International Prostate Score System) at 1, 3 and 6 months after treatment. Timepoint: 1, 3 and 6 months after transurethral resection of the prostate are checked. Method of measurement: Based on Urodynamic test.</prim_outcome>
      <prim_outcome>Q MAX(Q maximum) is administered in two treatment groups  botulinum and sulifenacin injection after TURP(International Prostate Score System) at 1, 3 and 6 months after treatment. Timepoint: 1, 3 and 6 months after transurethral resection of the prostate are checked. Method of measurement: Based on Urodynamic test.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-27</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahrdari St. Shohada-E-Tajrish Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
