<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/NCT03809819</url>
  </required_header>
  <id_info>
    <org_study_id>03/2019</org_study_id>
    <nct_id>NCT03809819</nct_id>
  </id_info>
  <brief_title>Urogynecological and Sexual Functions After Vecchietti Operation</brief_title>
  <official_title>Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lublin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lublin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to establish the urogynecological and sexual functions after&#xD;
      Vecchietti operation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty were&#xD;
      included. A control group of 13 age-matched, childless, sexually active women were examined&#xD;
      during the same period. All patients underwent the basic evaluation of anatomical outcomes.&#xD;
      Sexual outcomes were established by polish validated FSFI questionnaire. Continence status&#xD;
      was assessed by polish validated UDI-6 and IIQ-7 questionnaires. The UDI-6 is subdivided in&#xD;
      three domains: stress incontinence, irritative and obstructive discomfort. The IIQ-7 measures&#xD;
      the implications of urinary incontinence for normal daily functioning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>sexual functions after Vecchietti operation</measure>
    <time_frame>8 years</time_frame>
    <description>assessment of sexual functions after Vecchietti operation with the use of The Female Sexual Function Index (FSFI) questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary incontinence after Vecchietti operation</measure>
    <time_frame>8 years</time_frame>
    <description>assessment of Urinary incontinence after Vecchietti operation with the use of the Urinary Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">26</enrollment>
  <condition>Mayer-Rokitansky-Kuster Syndrome</condition>
  <arm_group>
    <arm_group_label>Patients with MRKHS</arm_group_label>
    <description>Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>A control group of 13 age-matched, childless, sexually active women</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic Vecchietti vaginoplasty</intervention_name>
    <description>Patients who underwent laparoscopic Vecchietti vaginoplasty</description>
    <arm_group_label>Patients with MRKHS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FSFI questionnaire</intervention_name>
    <description>Completion of FSFI questionnaire</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Patients with MRKHS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>UDI-6 questionnaire</intervention_name>
    <description>Completion of UDI-6 questionnaire</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Patients with MRKHS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IIQ-7 questionnaire</intervention_name>
    <description>Completion of IIQ-7 questionnaire</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Patients with MRKHS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty were&#xD;
        included. A control group of 13 age-matched, childless, sexually active women were examined&#xD;
        during the same period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty&#xD;
&#xD;
          -  control group of 13 age-matched, childless, sexually active women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unability to understand informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Paweł Miotła, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University in Lublin</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Lublin</investigator_affiliation>
    <investigator_full_name>Paweł Miotła</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Laparoscopic Vecchietti vaginoplasty</keyword>
  <keyword>sexual function</keyword>
  <keyword>urinary incontinence</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03809819
org study id: 03/2019
nct id: NCT03809819
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to establish the urogynecological and sexual functions after
      Vecchietti operation.
Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty were
      included. A control group of 13 age-matched, childless, sexually active women were examined
      during the same period. All patients underwent the basic evaluation of anatomical outcomes.
      Sexual outcomes were established by polish validated FSFI questionnaire. Continence status
      was assessed by polish validated UDI-6 and IIQ-7 questionnaires. The UDI-6 is subdivided in
      three domains: stress incontinence, irritative and obstructive discomfort. The IIQ-7 measures
      the implications of urinary incontinence for normal daily functioning.
observational model: Case-Control
time perspective: Retrospective
measure: sexual functions after Vecchietti operation
time frame: 8 years
description: assessment of sexual functions after Vecchietti operation with the use of The Female Sexual Function Index (FSFI) questionnaire
measure: Urinary incontinence after Vecchietti operation
time frame: 8 years
description: assessment of Urinary incontinence after Vecchietti operation with the use of the Urinary Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7)
arm group label: Patients with MRKHS
description: Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
arm group label: Control group
description: A control group of 13 age-matched, childless, sexually active women
intervention type: Procedure
intervention name: laparoscopic Vecchietti vaginoplasty
description: Patients who underwent laparoscopic Vecchietti vaginoplasty
arm group label: Patients with MRKHS
intervention type: Diagnostic Test
intervention name: FSFI questionnaire
description: Completion of FSFI questionnaire
arm group label: Control group
arm group label: Patients with MRKHS
intervention type: Diagnostic Test
intervention name: UDI-6 questionnaire
description: Completion of UDI-6 questionnaire
arm group label: Control group
arm group label: Patients with MRKHS
intervention type: Diagnostic Test
intervention name: IIQ-7 questionnaire
description: Completion of IIQ-7 questionnaire
arm group label: Control group
arm group label: Patients with MRKHS
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Paweł Miotła, PhD
role: Principal Investigator
affiliation: Medical University in Lublin
responsible party type: Principal Investigator
investigator affiliation: Medical University of Lublin
investigator full name: Paweł Miotła
investigator title: Clinical Professor
sharing ipd: No