<?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>IRCT20130306012728N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-02</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the surgical result of urethroplasty by vaginal wall flap in female urethral stricture in a pilot study</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the surgical result of urethroplasty by vaginal wall flap in female urethral stricture in a pilot study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30853</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>female urethral stricture.</hc_freetext>
      <i_freetext>Intervention group: Patients with urinary tract stenosis aged over 18 years who indicated  stenosis treatment  of the urinary tract and had no proper reaction to coservative, drug and dilatation therapies, or an unreliable uncertainty in the conduct of the abovementioned measures, and pvr was more than 100 they were prepared for orthoplasty using vaginal flaps.Patients are placed in the dorsal position of the lithotomy and foley catheter was inserted into the urinary bladder. the anterior wall of the vaginal  two parallel incisions on the two sides of the meatus to the proximal maximal of 4 cm {depending on the length of the stenosis} are given  and a 1.8 to 2 cm  of the vaginal wall flap is dissected. Then the distal part of the flap is fluttered to the proximal flap and the inner part of the flap is tubularized  over bigger size of foley catheter[20fr] with absorbable vicryle. The second layer of folded  vaginal wall is sutured to native vagina with 3-0 vicryl.Then the  foley catheter is removed after 2 weeks..</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:
Through publication as an article

When:
Through publication as an article

To whom:
Through publication as an article

Conditions:
Through publication as an article

Where to obtain:
Through publication as an article

How to obtain:
Through publication as an article

Comments:
Through publication as an article</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Hamed Marofi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urology department, Educational and treatment center of Imam Reza, Golgasht Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>51666-14756</zip>
        <telephone>+98 41 3335 7328</telephone>
        <email>hamedmarofi5@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Prof. Sakineh Hajebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Urology,Imam Reza educational and treatment center, Golgasht Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>04151666-14756</zip>
        <telephone>+98 984133357328</telephone>
        <email>hajebrahimis@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with urinary tract stricture                                               aged over 18 years who had stricure of the urethra                      and did not respond to conservative, drug and dilatation treatments,                                                                                          or did not have an informed consent to the above measures,    and had a higher than 100 cc pvr ,                                                      if satisfied with orthoplasty Using the vaginal flap</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients with skin problems such as Lichen planus                            or Immunosupercise,                                                                                or virginal patients,                                                                                          not the deliberate consent of the above surgery [after the describtion],                                                                                          or those who have had neurogenic bladder in the eurorodynamics , are excluded from the action list.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N35.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other urethral stricture</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with urinary tract stenosis aged over 18 years who indicated  stenosis treatment  of the urinary tract and had no proper reaction to coservative, drug and dilatation therapies, or an unreliable uncertainty in the conduct of the abovementioned measures, and pvr was more than 100 they were prepared for orthoplasty using vaginal flaps.Patients are placed in the dorsal position of the lithotomy and foley catheter was inserted into the urinary bladder. the anterior wall of the vaginal  two parallel incisions on the two sides of the meatus to the proximal maximal of 4 cm {depending on the length of the stenosis} are given  and a 1.8 to 2 cm  of the vaginal wall flap is dissected. Then the distal part of the flap is fluttered to the proximal flap and the inner part of the flap is tubularized  over bigger size of foley catheter[20fr] with absorbable vicryle. The second layer of folded  vaginal wall is sutured to native vagina with 3-0 vicryl.Then the  foley catheter is removed after 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Females urethral stricture. Timepoint: 3 to 12 months after intervention. Method of measurement: Eurodynamic- questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Normal voiding. Timepoint: 3-12  months after intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Recurrence of symptoms. Timepoint: 3-12 months after intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Create fistulas. Timepoint: 3-12  months after intervention. Method of measurement: questionnaire and cystoscopy.</sec_outcome>
      <sec_outcome>Create Incontinence. Timepoint: 3-12  months after intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Recurrence of stricture. Timepoint: 3-12  months after intervention. Method of measurement: With Eurodynamics and Cystoscopy.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-30</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Attar Neyshabouri Street, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
