<?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>IRCT20241010063320N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-25</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>comparison of Effect of TTNS vs anticholinergic in OAB</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of quality of life and clinical results of posterior tibial nerve stimulation and selective anticholinergic treatment in multiple sclerosis patients with neurogenic bladder in a randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79537</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to each of the study groups using a random number table. In this way, at the time of the patient's consultation, the questionnaires, randomly half of them are in the physiotherapy group and the other half of them are in the drug treatment sub-group. The placement of the questionnaire is random and confusing, and the questionnaires and treatment method are all covered with white paper and cannot be distinguished from the content inside at the time of use. Then randomly at the time of visit, an envelope is taken by the doctor, who is unaware of the treatment method, and the method of treatment is determined from it, and the patient also fills the questionnaire inside the same envelope. The patient's name is written on this envelope and the patient fills out the questionnaire again during the next follow-up to check the changes in his condition after the treatment, Blinding description: The method of blinding is that both the doctor and the patient are unaware of the content of the cards at the time of conducting this research. At the beginning of the study, questionnaire envelopes were printed for the total number of participants, which are all the same, then this questionnaire and the name of the treatment method, which is either physiotherapy or drug treatment, are placed inside each envelope containing the questionnaire separately. And all this After closing, the envelopes are randomly placed together and the doctor gives each patient an envelope, so both the doctor and the patient are unaware of the treatment method.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Over active bladder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Treatment with transcutaneous posterior tibial nerve stimulation. Intervention 2: Intervention group: Treatment with selective anticholinergics.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All the data including the initial history and all the questionnaires before and after the treatment can be published

When:
Access period starts 6 months after publication

To whom:
Only for researchers in academic and scientific institutions

Conditions:
Making citations to articles and scientific and academic uses

Where to obtain:
Responding to requests sent to emails

How to obtain:
After the request to zeinabashoori1373@gmail.com email will be answered within a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeiab ashoori ghazi mahaleh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 8, west rashid ave , khodami blvd, vanak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1994615716</zip>
        <telephone>+98 21 8879 1483</telephone>
        <email>Zeinabashoori1372@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam emami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valinezhad ave , hasheminezhad hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1969414713</zip>
        <telephone>+98 21 8116</telephone>
        <email>Emami59658@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Multiple sclerosis confirmed by a neurologist
Urodynamic findings based on overactive bladder</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sacral peripheral nerve lesions
UTI
Specific prostate size in digital rectal examination
Bladder outlet obstruction
Pregnancy
Diabet melitus type 2
Severe cardio_pulmonary disease
History of urinary control surgery
Current bladder malignancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N32.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified disorders of bladder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Treatment with transcutaneous posterior tibial nerve stimulation</i_keyword>
      <i_keyword>Intervention group: Treatment with selective anticholinergics</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Questionnaire ICIQ_OAB. Timepoint: Comparison between questionnaires in both groups, one at the beginning of treatment and the other 12 weeks after treatment. Method of measurement: Questionnaire ICIQ_OAB &amp; Questionnaire ICIQ_QOL.</prim_outcome>
      <prim_outcome>Questionnaire ICIQ_QOL. Timepoint: Comparison between questionnaires in both groups, one at the beginning of treatment and the other 12 weeks after treatment. Method of measurement: Questionnaire ICIQ_QOL.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-28</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>No 8 mwst rashid gharbi ave, khodami blvd, vanak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
