<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03267472</url>
  </required_header>
  <id_info>
    <org_study_id>genitourinary fistula</org_study_id>
    <nct_id>NCT03267472</nct_id>
  </id_info>
  <brief_title>Pattern of Genitourinary Fistula in Upper Egypt</brief_title>
  <official_title>the Genitourinary Fistula Experience in Upper Egypt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      the pattern of genitourinary fistula in upper egypt&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A genitourinary fistula is defined as an abnormal communication between the urinary (ureters,&#xD;
      bladder, urethra) and the genital (uterus, cervix, vagina) systems.&#xD;
&#xD;
      The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great&#xD;
      challenge for women in developing countries.&#xD;
&#xD;
      The new classification of genitourinary fistula divides genitourinary fistulae into four main&#xD;
      types, depending on the distance of the distal edge of the fistula from the external urinary&#xD;
      meatus. These four types are further subclassified by the size of the fistula, extent of&#xD;
      associated scarring, vaginal length or special considerations:&#xD;
&#xD;
      Type 1: Distal edge of fistula &gt; 3.5 cm from external urinary meatus Type 2: Distal edge of&#xD;
      fistula 2.5-3.5 cm from external urinary meatus Type 3: Distal edge of fistula 1.5 - &lt; 2.5 cm&#xD;
      from external urinary meatus&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 20, 2017</start_date>
  <completion_date type="Anticipated">October 20, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 20, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prevalence of genitourinary fistula in upper egypt</measure>
    <time_frame>5 years</time_frame>
    <description>to detect how many numbers of cases of genitourinary fistula in upper egypt .</description>
  </primary_outcome>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Data Collection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A genitourinary fistula is defined as an abnormal communication between the urinary&#xD;
        (ureters, bladder, urethra) and the genital (uterus, cervix, vagina) systems.&#xD;
&#xD;
        The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great&#xD;
        challenge for women in developing countries. The new classification of genitourinary&#xD;
        fistula divides genitourinary fistulae into four main types, depending on the distance of&#xD;
        the distal edge of the fistula from the external urinary meatus.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - any female with genitourinary fistula&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>AHMED FARAHAT HASSAN</investigator_full_name>
    <investigator_title>ahmed farahat hassan</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03267472
org study id: genitourinary fistula
nct id: NCT03267472
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
the pattern of genitourinary fistula in upper egypt
A genitourinary fistula is defined as an abnormal communication between the urinary (ureters,
      bladder, urethra) and the genital (uterus, cervix, vagina) systems.

      The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great
      challenge for women in developing countries.

      The new classification of genitourinary fistula divides genitourinary fistulae into four main
      types, depending on the distance of the distal edge of the fistula from the external urinary
      meatus. These four types are further subclassified by the size of the fistula, extent of
      associated scarring, vaginal length or special considerations:

      Type 1: Distal edge of fistula > 3.5 cm from external urinary meatus Type 2: Distal edge of
      fistula 2.5-3.5 cm from external urinary meatus Type 3: Distal edge of fistula 1.5 - < 2.5 cm
      from external urinary meatus
observational model: Case-Control
time perspective: Retrospective
measure: prevalence of genitourinary fistula in upper egypt
time frame: 5 years
description: to detect how many numbers of cases of genitourinary fistula in upper egypt .
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: AHMED FARAHAT HASSAN
investigator title: ahmed farahat hassan
mesh term: Fistula