<?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>IRCT20131203015634N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-27</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of oral sodium bicarbonate on the symptoms of overactive bladder and acidic urine</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of oral sodium bicarbonate and tolterodine in women with symptoms of overactive bladder and  acidic urine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60909</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the table of random numbers, some people are given sodium bicarbonate tablets and others are given tolterodine tablets, so that according to the random numbers table, people with even numbers of sodium bicarbonate tablets are given and people who were given individual numbers are given tolterodine tablets. The number will be 72 and there are two groups, each of which 36 people will enter, Blinding description: The two groups in the first group receive tolterodine and the second group receive sodium bicarbonate. While the tablets are packed in a white pharmacy, respectively, they will be referred to the case and control group after randomization. Patients  are not aware of the type of drug given. The patient receives the first package drug and 36 patients receive the second group drug and the analysis is performed.</study_design>
      <phase>2-3</phase>
      <hc_freetext>over active bladder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Women with acidic urine and hyperactive bladder symptoms over 18 years of age who are randomly selected and treated with sodium bicarbonate 500 twice a day by 36 patients in the intervention group. Sodium bicarbonate tablets produced by Raha Pharmaceutical Company. Intervention 2: Control group: Control group: Women with acidic urine and symptoms of hyperactive bladder over 18 years old who are randomly selected and treated with tolterodine 1 mg twice daily in 36 patients in the control group. Tehran Daroo Pharmaceutical Company has been produced.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Jahed Bozorgan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>" SIDE OF AYATOLLAH TALEGANI HOSPITAL , SHAHID ARABI AVENUE , YAMAN AVENUE ,SHAHID CHAMRAN HIGHW</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1185817311</zip>
        <telephone>+98 21 5506 6263</telephone>
        <email>tayebe.jahed@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tayebeh Jahed Bozorgan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>47 / 5,000 Translation results "Shahid Chamran Highway, Yemen Street, Arabi Street"</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1185817311</zip>
        <telephone>+98 21 5506 6263</telephone>
        <email>tayebe.jahed@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients referred to the gynecology clinic included all patients over 18 years of age who voluntarily and knowingly complained of overactive bladder symptoms who had these symptoms for at least 12 weeks and received no treatment, had a frequency of more than 8 times and more than 2 times nocturia, urinary pH less than 6 and lacked of relaxation. Patients under 18 years of age, urinary pH more than 6, kidney stones, stress incontinence, history of abdominal menopause surgery, heart problems, urinary tract infections, malignancies, pelvic pain,   neurogenic bladder , Use of antidepressants, anticholinergics, alphablockers, beta-3 agonists, and history of allergies to anticholinergics, sodium bicarbonate, rectocell, cystocell, and uterine prolapse, frequency Less than 8 and nocturia less than 2 in 24 hours are not included in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>If the patient does not want to continue taking. Allergic reaction to the drug. The patient becomes pregnant. Reluctance to continue cooperation in the project. They are excluded from the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N32.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overactive bladder</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: Women with acidic urine and hyperactive bladder symptoms over 18 years of age who are randomly selected and treated with sodium bicarbonate 500 twice a day by 36 patients in the intervention group. Sodium bicarbonate tablets produced by Raha Pharmaceutical Company.</i_keyword>
      <i_keyword>Control group: Control group: Women with acidic urine and symptoms of hyperactive bladder over 18 years old who are randomly selected and treated with tolterodine 1 mg twice daily in 36 patients in the control group. Tehran Daroo Pharmaceutical Company has been produced.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>OVER ACTIVE BLADDER SCORE POINT. Timepoint: One month after taking the drug. Method of measurement: questionnaire OAB-V8.</prim_outcome>
      <prim_outcome>URINE PH. Timepoint: Before administration of tolterodine and sodium bicarbonate at the beginning of the study and one month after receiving tolterodine and sodium bicarbonate. Method of measurement: urine dipstick.</prim_outcome>
      <prim_outcome>Oab-v8 questionnaire score based on score before and after receiving tolterodine and sodium bicarbonate. Timepoint: Before administration of tolterodine and sodium bicarbonate at the beginning of the study and one month after receiving tolterodine and sodium bicarbonate. Method of measurement: Scoring based on the score of the questionnaire.</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>2022-01-04</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Mahdieh Hospital, Fadaiyan-e-Islam Blvd. tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
