<?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>IRCT20251121068066N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-15</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the Effect of Alternating Tadalafil and Tamsulosin Compared with Tamsulosin Alone</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Alternate-Day Tadalafil and Tamsulosin Use with Daily Tamsulosin Use on Lower Urinary Tract Symptoms and Sexual Dysfunction in Men with Benign Prostatic Hyperplasia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/92278</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were recruited using convenience sampling. Treatment codes were prepared and placed in blinded packages before the start of the study. After eligibility screening and obtaining written informed consent, participants were sequentially entered into the predetermined randomization sequence according to their order of enrollment. Participants were randomly allocated in a 1:1 ratio to the intervention or control group using block randomization with a block size of four. The corresponding treatment assignment was placed in a sequentially numbered, opaque, sealed envelope and will be performed by an independent urologist who is not involved in the research team.</study_design>
      <phase>2</phase>
      <hc_freetext>Benign Prostatic Hyperplasia; BPH.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:Participants will receive 0.4 mg of tamsulosin from Actover brand daily for 12 weeks. Intervention 2: Intervention group 2: Participants will receive an alternating regimen of tadalafil 5 mg (Mofid) and tamsulosin 0.4 mg (Actover) on alternate days for 12 weeks, such that one medication (tadalafil or tamsulosin) is taken each 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>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 No more information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Soleimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Modarres Hospital, Yadegar-e Imam Expressway, Saadat Abad Intersection, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998734383</zip>
        <telephone>+98 21 2204 7021</telephone>
        <email>mohamad.soleimani.md@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Soleimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Modarres Hospital, Yadegar-e Imam Expressway, Saadat Abad Intersection, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998734383</zip>
        <telephone>+98 21 2204 7021</telephone>
        <email>mohamad.soleimani.md@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men aged ≥50 years.
Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH).
International Prostate Symptom Score (IPSS) &gt;10.
Prostate volume &gt;20 mL.
Ability to complete study questionnaires and participate in the 12-week follow-up.
No use of BPH medications within the previous 2 months or completion of an appropriate washout period.
Provision of written informed consent.</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>PSA ≥4 ng/mL without prior evaluation and exclusion of prostate malignancy.
History or clinical suspicion of prostate cancer.
Previous prostate or lower urinary tract surgery.
Acute urinary retention or current need for indwelling catheterization.
Active urinary tract infection, urethral stricture, bladder stones, or neurogenic bladder.
Severe renal impairment (eGFR &lt;30 mL/min/1.73 m²) or severe hepatic impairment.
Myocardial infarction or stroke within the previous 3 months.
Symptomatic hypotension, unstable cardiovascular disease, or uncontrolled diabetes.
Symptomatic hypotension or unstable cardiovascular disease.
Uncontrolled diabetes mellitus.
Current use of nitrates or medications with clinically significant interactions with tadalafil.
Known hypersensitivity or contraindication to tamsulosin or tadalafil.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Enlarged 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 1:Participants will receive 0.4 mg of tamsulosin from Actover brand daily for 12 weeks.</i_keyword>
      <i_keyword>Intervention group 2: Participants will receive an alternating regimen of tadalafil 5 mg (Mofid) and tamsulosin 0.4 mg (Actover) on alternate days for 12 weeks, such that one medication (tadalafil or tamsulosin) is taken each day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lower urinary tract symptoms (LUTS). Timepoint: Lower urinary tract symptoms  will be evaluated at baseline (prior to treatment) and at 12 weeks following treatment. Method of measurement: Lower urinary tract symptoms will be assessed using the International Prostate Symptom Score (IPSS) questionnaire. This validated instrument evaluates the severity of urinary obstructive and irritative symptoms, with higher scores indicating greater symptom severity.</prim_outcome>
      <prim_outcome>Sexual function. Timepoint: Sexual function will be assessed at baseline and 12 weeks after treatment. Method of measurement: Sexual function will be evaluated using the International Index of Erectile Function (IIEF) questionnaire. This 15-item instrument assesses erectile function and sexual satisfaction.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Peak urinary flow rate (Qmax). Timepoint: Peak urinary flow rate will be assessed at baseline and at 12 weeks following treatment. Method of measurement: Peak urinary flow rate will be measured by uroflowmetry. The outcome will be reported as milliliters per second (mL/s).</sec_outcome>
      <sec_outcome>Post-void residual urine volume. Timepoint: Postvoid residual urine volume will be assessed at baseline and at 12 weeks after treatment. Method of measurement: Postvoid residual urine volume will be measured using a urinary catheter.</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>2026-07-28</approval_date>
        <contact_name>Research Ethics Committee of School of Medicine - Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>School of Medicine, Shahid Beheshti University of Medical Sciences, Koodak‑Yar Street, Daneshjoo Boulevard, Velenjak,Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
