<?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>IRCT20171201037697N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-04</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Study on the effect of PRP on the treatment of urinary incontinenece</public_title>
      <acronym></acronym>
      <scientific_title>Study on the effect of paraurethral injection of platelet rich plasma on the treatment of stress urinary incontinence in women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31122</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stress urinary incontinence.</hc_freetext>
      <i_freetext>Intervention 1: intervention group:blood sampling was done.20ml of intravenous blood was taken on anticoagulant (ACD) and centrifuged in15ml Falcon tubes for 10 minutes at 800 RPM, and after separation and transfer of platelet-rich plasma"Which was deposited on RBCs", was added to 15ml new falcons and re-centrifuged for 15 minutes at 3500 RPM, after removing of upper part of plasma , concentrated platelet was obtained. About 3ml of this concentrate was taken with an insulin syringe and then in the operating room under general anesthesia with cyctourethroscopy and special needles injected at two points of the rabdosphingter(in the middle of the urethra) by the urologist. and then Platelet-rich-plasma was injected at two points with lower depth in the submucosa separately for supportive effect .This method did not require hospitalization after intervention. Intervention 2: Control group: after receiving satisfaction and performing routine preoperative tests, in the operating room  and under general anesthesia, patients were treated with midurethral sling surgury by the urologist (standard treatment of urinary stress incontinence). they were admitted and monitored for 24-24 hours after surgery.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefe eslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eghlid .shhrmian village.mahdieh clinic</address>
        <city>Eghlid</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7381689611</zip>
        <telephone>+98 71 4452 0136</telephone>
        <email>Atefe_eslami70@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.azar daneshpajooh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman.shahid gharani Ave</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613747181</zip>
        <telephone>+98 32235011</telephone>
        <email>Azdaneshpajooh@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female
Existence of Stress urinary incontinence(SUI) symptom
Confirm of SUI based on urodinamic test
Positive cough stress test
Age 30 - 65 Yr
No reply to conversative treeatment or intrested in surgical treatment for SUI</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>post void residual (PVR) more than 100cc
evidence of Detrusor overactivity in urodynamic test before surgery
Positive history for midurethral sling surgery or any surgery on external genitalia ,bladder, bladder neck or urethra
Genitourinary  system infection
Genitourinary system malignancy
Positive  history of bleeding disorders or  recent anticoagulant treatment
Positive recent history of Genitourinary fistula or urethral diverticulum
Positive recent history of cyctocele or rectocele
Uncontrolled diabetes mellitus
Any contraindication for surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress incontinence (female) (male)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group:blood sampling was done.20ml of intravenous blood was taken on anticoagulant (ACD) and centrifuged in15ml Falcon tubes for 10 minutes at 800 RPM, and after separation and transfer of platelet-rich plasma"Which was deposited on RBCs", was added to 15ml new falcons and re-centrifuged for 15 minutes at 3500 RPM, after removing of upper part of plasma , concentrated platelet was obtained. About 3ml of this concentrate was taken with an insulin syringe and then in the operating room under general anesthesia with cyctourethroscopy and special needles injected at two points of the rabdosphingter(in the middle of the urethra) by the urologist. and then Platelet-rich-plasma was injected at two points with lower depth in the submucosa separately for supportive effect .This method did not require hospitalization after intervention.</i_keyword>
      <i_keyword>Control group: after receiving satisfaction and performing routine preoperative tests, in the operating room  and under general anesthesia, patients were treated with midurethral sling surgury by the urologist (standard treatment of urinary stress incontinence). they were admitted and monitored for 24-24 hours after surgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Severity of urinary incontinence. Timepoint: 0,1,3 month ofter intervention. Method of measurement: International Consultation on Incontinence Questionnaire(ICIQ) ,                                                The Questionnaire for Urinary Incontinence Diagnosis(QUID ) ,                                               clinical examination( cough stress test).</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: 0,1,3 month ofter intervention. Method of measurement: The Incontinence Quality of Life questionnaire(I-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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-25</approval_date>
        <contact_name>Ethics committee of kerman university of medical sciences</contact_name>
        <contact_address>Kerman.haft bagh alavi AVe.paradis of kerman university of medical sciences Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
