<?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>IRCT2016101730339N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-04</date_registration>
      <primary_sponsor>Vice Cancellor for Research , Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparative effect of Percutaneous Tibial Nerve Stimulation versus Transcutaneous Posterior Tibial Nerve Stimulation efficacy in the treatment of Overactive Bladder Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effect of Percutaneous Tibial Nerve Stimulation versus Transcutaneous Posterior Tibial Nerve Stimulation efficacy in the treatment of Overactive Bladder Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24135</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overactive Bladder Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: On the second group, Posterior Tibial Nerve Stimulation method is done with a surface pad electrod on the 5 cm to superior side of the medial Malleolus and posterior to tibia. The null electrod is located on the arch of the same foot by the surface Pad.The electrical stimulation is done by the 0.5 to 0.9 mAmp and 20 Hz current by the voltage which can induce plantar flextion on the toe or other toes. Each time stimulation is done for 30 mins for a single session , 3 session a week and total sessions of 12. Intervention 2: In the first group, Posterior Tibial Nerve Stimulation method is done with a single gauge 34 filliform needle inserted on the 5 cm to superior side of the medial Malleolus and posterior to tibia. The null electrod is located on the arch of the same foot by the surface Pad.The electrical stimulation is done by the 0.5 to 0.9 mAmp and 20 Hz current by the voltage which can induce plantar flextion on the toe or other toes. Each time stimulation is done for 30 mins for a single session , 3 session a week and total sessions of 12.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Esmail Nouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Medicine and Rehabilitation, Behafarin St., Karim Khan Zand Ave., Tehran , Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8214 1229</telephone>
        <email>drn94778@gmail.com,&#13;
pghaboussi@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences (IUMS), Faculty of Medicine</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Gholamreza Raissi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Medicine and Rehabilitation, Behafarin St., Karim Khan Zand Ave., Tehran , Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8214 1229</telephone>
        <email>graissi@gmail.com</email>
        <affiliation>Iran University of Medical Sciences (IUMS), Faculty of Medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria:&#13;
Criteria for Overactive Bladder by American Urological Association 2014 Guideline:&#13;
Each of these Items:&#13;
 Urgency: Sudden feeling of voiding that is irressitable;&#13;
 Frequency: Urination for more than 7 times during wakefulness;&#13;
 Nocturia: Waking for uriantion for more than 1 time;&#13;
 Incontinence: Sudden Involuntary Urine Leakage;&#13;
 Minimun of 18 years for age;&#13;
 Irrisponsiveness to Medical Therapy or Behavioral Change Therapies like Lifestyle Modification and Exercise Therapy;&#13;
 No Usge of Anticholinergic Medications&#13;
&#13;
Exclusion Criteria:&#13;
 Diabetes Mellitus;&#13;
 Pregnancy or Intention for that;&#13;
 Urinary Tract Infection or Recurrent Urinary Tract Infection (For more than 4 times a year);&#13;
 Pacemaker Device;&#13;
 Neurological Diseases;&#13;
 Lack of Cooperation or Follow Up</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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 Incl.: calcified, contracted or overactive Bladder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>On the second group, Posterior Tibial Nerve Stimulation method is done with a surface pad electrod on the 5 cm to superior side of the medial Malleolus and posterior to tibia. The null electrod is located on the arch of the same foot by the surface Pad.The electrical stimulation is done by the 0.5 to 0.9 mAmp and 20 Hz current by the voltage which can induce plantar flextion on the toe or other toes. Each time stimulation is done for 30 mins for a single session , 3 session a week and total sessions of 12.</i_keyword>
      <i_keyword>In the first group, Posterior Tibial Nerve Stimulation method is done with a single gauge 34 filliform needle inserted on the 5 cm to superior side of the medial Malleolus and posterior to tibia. The null electrod is located on the arch of the same foot by the surface Pad.The electrical stimulation is done by the 0.5 to 0.9 mAmp and 20 Hz current by the voltage which can induce plantar flextion on the toe or other toes. Each time stimulation is done for 30 mins for a single session , 3 session a week and total sessions of 12.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Overactive Bladder Symptom. Timepoint: 0, 1 and 6  months after treatment. Method of measurement: Overactive Bladder Symtom Score.</prim_outcome>
      <prim_outcome>Quality Of Life due to Incontinence. Timepoint: 0, 1 and 6 months after treatment. Method of measurement: Incontinence - Quality Of Life Questionnaire Items.</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>Vice Cancellor for Research , Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-02</approval_date>
        <contact_name>Ethics Commitee of Iran University Of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway. Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
