<?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>IRCT20190517043609N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-03</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of surgery and stem cell therapy in the treatment of women’s urinary incontinence</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of comparison of medium-term results of single incision mini-sling and stem cell therapy in the treatment of women’s stress urinary incontinence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47057</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used by using blocks of size 6, in each block consisting 3 part is for surgical intervention group and 3 is for injection intervention group, with the aim that the groups progress in a balanced way over time and
This method continues until the sample size reaches 30 people (including 15 intervention groups and 15 control groups or 5 blocks of 6), Blinding description: The study is single blind and the patient do not know the type of treatment (surgery or injection) performed but the primary researcher (physician and data collector) knows the type of treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Stress Urinary incontinence.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: In the stem cell injection group: After obtaining written consent, the mucosal tissue sample is separated from the volunteer patients by the physician and placed in a phosphate buffer solution containing antibiotics and amphotericin and sent immediately to the university stem cell center. The cells collected for injection into the patient are given to the physician as a suspension. After obtaining the required amount of stem cells (6 10 10 64), the sample is sent to the urology operating room as freez, and after melting with normal saline, it is 0.9% diluted (up to 4 cc) and with a cystoscope in two areas in the sphincter. The external urine is injected (8 injections 0.5 cc). After three months, the injection is given again. Intervention 2: Intervention group2: In the other group, for mini-sling surgery with mesh insertion, after venous sedation and lithotomy position with a 1 cm mid-urethral incision, a short arm mesh of Boston company is inserted.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahbube Mirzaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Science,Emam khomeini Blv,Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>mirzaeimahboubeh@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahbube Mirzaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Science;Emam Khomeini Blv,Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>mirzaeimahboubeh@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women at least 18 years old
history of SUI (Stress Urinary Incontinence)
Failure to respond to conservative managements after 3 months
Urine leak in the initial examination during coughing or Valsalva maneuver</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>persistent urinary tract infection (UTI)
proved Vesicouretral Reflux (VUR)
History of previous Stress urinary incontinence surgery
history of neurological diseases such as Cerebro Vascular Accident(CVA) ,muscular dystrophy or Multiple Sclerosis(MS)
Obesity (Body Mass Index(BMI)&gt; 40)
Localized fibrosis and stiffness at the injection site in the cystoscopy
high grade cystocele and rectocele (equal to or more than 3 according to the pelvic organ prolapse quantification system (POP-Q)
Overactive bladder symptoms (Uninhibited contractions, low capacity, low compliance in urodynamic study)
Medium to severe bladder trabeculation and or open bladder neck in cystourethroscopy
Residue of urine &gt; 100cc and or maximum flow rates of lower than 15 ml/s
Pregnant or intending future pregnancies
coagulation disorders
history of Bulking agent injection in urethra</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: In the stem cell injection group: After obtaining written consent, the mucosal tissue sample is separated from the volunteer patients by the physician and placed in a phosphate buffer solution containing antibiotics and amphotericin and sent immediately to the university stem cell center. The cells collected for injection into the patient are given to the physician as a suspension. After obtaining the required amount of stem cells (6 10 10 64), the sample is sent to the urology operating room as freez, and after melting with normal saline, it is 0.9% diluted (up to 4 cc) and with a cystoscope in two areas in the sphincter. The external urine is injected (8 injections 0.5 cc). After three months, the injection is given again.</i_keyword>
      <i_keyword>Intervention group2: In the other group, for mini-sling surgery with mesh insertion, after venous sedation and lithotomy position with a 1 cm mid-urethral incision, a short arm mesh of Boston company is inserted.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Examination of stress urinary. Timepoint: 1, 3, 6 and 12 months after the intervention ( surgery or stem cell injection). Method of measurement: International Urinary Incontinence Questionnaire(IIQ score).</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>2016-08-25</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman University of Medical Sciences; Emam Khomeini blvd Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
