<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/NCT03809806</url>
  </required_header>
  <id_info>
    <org_study_id>02/2019</org_study_id>
    <nct_id>NCT03809806</nct_id>
  </id_info>
  <brief_title>Four-arm Mesh for Vaginal Stump Prolapse</brief_title>
  <official_title>Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes</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>
      To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery&#xD;
      using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy&#xD;
      (stage III and IV vc Pelvic Organ Prolapse Quantification [POP-Q] system staging).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pelvic reconstructive procedures were primarily performed using the transvaginal four arm&#xD;
      polypropylene mesh, which was inserted through: upper arms- anterior part of obturator&#xD;
      foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent&#xD;
      hysterectomy in the past apart from one which underwent vaginal hysterectomy during the&#xD;
      procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective&#xD;
      evaluations included Pelvic Organ Prolapse Quantification [POP-Q] staging, preoperative and&#xD;
      1-year postoperative questionnaires were performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients with vaginal stump prolapse who had undergone hysterectomy in the past</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure</measure>
    <time_frame>1 year</time_frame>
    <description>assessment of POPQ 1 year after mesh operation, Pelvic Organ Prolapse Quantification system (POP-Q) refers to an objective, site-specific system for describing, quantifying, and staging pelvic support in women. It provides a standardized tool for documenting, comparing, and communicating clinical findings with proven interobserver and intraobserver reliability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sexual function 1 year after procedure</measure>
    <time_frame>1 year</time_frame>
    <description>assessment of sexual function before and 1 year after the procedure with the use of The Female Sexual Function Index questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary incontinence 1 year after procedure</measure>
    <time_frame>1 year</time_frame>
    <description>assessment of urinary incontinence before and 1 year after the procedure with the use of the Urogenital Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life 1 year after procedure</measure>
    <time_frame>1 year</time_frame>
    <description>assessment of quality of life before and 1 year after the procedure with the use of The Short Form Health Survey (SF 36)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Sexual Function Abnormal</condition>
  <arm_group>
    <arm_group_label>patients after hysterectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>modified anterior transvaginal mesh surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>4-arm polypropylene mesh surgery</intervention_name>
    <description>Pelvic reconstructive procedures were performed with the use of 4-arm mesh:upper arms through- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments.</description>
    <arm_group_label>patients after hysterectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>The Female Sexual Function Index (FSFI) questionnaire</intervention_name>
    <description>patients fulfilled questionnaire before and 1 year after procedure</description>
    <arm_group_label>patients after hysterectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>King Health Questionnaire (KHQ)</intervention_name>
    <description>patients fulfilled questionnaire before and 1 year after procedure</description>
    <arm_group_label>patients after hysterectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pelvic Organ Prolapse Quantification (POPQ) staging</intervention_name>
    <description>Pelvic Organ Prolapse staging before and 1 year after the procedure</description>
    <arm_group_label>patients after hysterectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Postoperative questionnaire</intervention_name>
    <description>Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure</description>
    <arm_group_label>patients after hysterectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>The Short Form Health Survey (SF 36) questionnaire</intervention_name>
    <description>patients fulfilled questionnaire before and 1 year after procedure</description>
    <arm_group_label>patients after hysterectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pelvic Organ Prolapse Quantification (POPQ) III and IV vc after hysterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  malignant diseases&#xD;
&#xD;
          -  unability to understand informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomasz Rechberger, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd Gynecology Department Medical University in Lublin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>2nd Gynecology Department</name>
      <address>
        <city>Lublin</city>
        <zip>20-954</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <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>vaginal stump prolapse</keyword>
  <keyword>sexual function</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <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/NCT03809806
org study id: 02/2019
nct id: NCT03809806
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery
      using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy
      (stage III and IV vc Pelvic Organ Prolapse Quantification [POP-Q] system staging).
Pelvic reconstructive procedures were primarily performed using the transvaginal four arm
      polypropylene mesh, which was inserted through: upper arms- anterior part of obturator
      foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent
      hysterectomy in the past apart from one which underwent vaginal hysterectomy during the
      procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective
      evaluations included Pelvic Organ Prolapse Quantification [POP-Q] staging, preoperative and
      1-year postoperative questionnaires were performed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients with vaginal stump prolapse who had undergone hysterectomy in the past
primary purpose: Treatment
masking: None (Open Label)
measure: Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure
time frame: 1 year
description: assessment of POPQ 1 year after mesh operation, Pelvic Organ Prolapse Quantification system (POP-Q) refers to an objective, site-specific system for describing, quantifying, and staging pelvic support in women. It provides a standardized tool for documenting, comparing, and communicating clinical findings with proven interobserver and intraobserver reliability
measure: Sexual function 1 year after procedure
time frame: 1 year
description: assessment of sexual function before and 1 year after the procedure with the use of The Female Sexual Function Index questionnaire
measure: Urinary incontinence 1 year after procedure
time frame: 1 year
description: assessment of urinary incontinence before and 1 year after the procedure with the use of the Urogenital Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7) questionnaire
measure: quality of life 1 year after procedure
time frame: 1 year
description: assessment of quality of life before and 1 year after the procedure with the use of The Short Form Health Survey (SF 36)
arm group label: patients after hysterectomy
arm group type: Other
description: modified anterior transvaginal mesh surgery
intervention type: Procedure
intervention name: 4-arm polypropylene mesh surgery
description: Pelvic reconstructive procedures were performed with the use of 4-arm mesh:upper arms through- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments.
arm group label: patients after hysterectomy
intervention type: Diagnostic Test
intervention name: The Female Sexual Function Index (FSFI) questionnaire
description: patients fulfilled questionnaire before and 1 year after procedure
arm group label: patients after hysterectomy
intervention type: Diagnostic Test
intervention name: King Health Questionnaire (KHQ)
description: patients fulfilled questionnaire before and 1 year after procedure
arm group label: patients after hysterectomy
intervention type: Diagnostic Test
intervention name: Pelvic Organ Prolapse Quantification (POPQ) staging
description: Pelvic Organ Prolapse staging before and 1 year after the procedure
arm group label: patients after hysterectomy
intervention type: Diagnostic Test
intervention name: Postoperative questionnaire
description: Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure
arm group label: patients after hysterectomy
intervention type: Diagnostic Test
intervention name: The Short Form Health Survey (SF 36) questionnaire
description: patients fulfilled questionnaire before and 1 year after procedure
arm group label: patients after hysterectomy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Tomasz Rechberger, Professor
role: Principal Investigator
affiliation: 2nd Gynecology Department Medical University in Lublin
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Lublin
investigator full name: Paweł Miotła
investigator title: Clinical Professor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No