<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/NCT03764891</url>
  </required_header>
  <id_info>
    <org_study_id>107159-E</org_study_id>
    <nct_id>NCT03764891</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of Transvaginal Mesh Procedures for Cystocele Repair: Comparisons of Uphold and Perigee Systems</brief_title>
  <official_title>Far Eastern Memorial Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</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>
      Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women.&#xD;
&#xD;
      The aim of this study was to compare the clinical outcomes of Uphold system and Perigee&#xD;
      system in treating women with cystocele.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women.&#xD;
      Traditional vaginal surgery with native tissue is associated with high recurrence rate. Thus,&#xD;
      synthetic meshes were introduced into POP surgery and became the mainstream. Several&#xD;
      transvaginal mesh procedures, such as Uphold system (Boston Scientific) and Perigee system&#xD;
      (American Medical Systems Inc), have been used for cystocele repair. Perigee system is a&#xD;
      trans-obturator four-arm mesh device attached to proximal and distal arcus tendineus fasciae&#xD;
      pelvis. Nonetheless, Uphold system, is a single incised, two-arm anterior sacrospinous mesh&#xD;
      fixation system. Both systems can be used for cystocele repair, despite Uphold system can be&#xD;
      used for concomitant repair of apical prolapse. The aim of this study was to compare the&#xD;
      clinical outcomes of Uphold system and Perigee system in treating women with cystocele.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2018</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 28, 2020</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>Recurrence rate of pelvic organ prolapse</measure>
    <time_frame>10 year</time_frame>
    <description>Compare the recurrence rate of Uphold system and Perigee system in treating women with cystocele.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>10 years</time_frame>
    <description>Compare the complication rate (such as mesh extrusion, dyspareunia, pelvic pain, voiding difficult, etc) of Uphold system and Perigee system in treating women with cystocele.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">152</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Surgical Mesh</condition>
  <arm_group>
    <arm_group_label>Uphold</arm_group_label>
    <description>Patients who underwent Uphold procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Perigee</arm_group_label>
    <description>Patients who underwent Perigee procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Uphold</intervention_name>
    <description>Uphold system in treating women with cystocele</description>
    <arm_group_label>Uphold</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Perigee</intervention_name>
    <description>Perigee system in treating women with cystocele</description>
    <arm_group_label>Perigee</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pelvic organ prolapse patients underwent Uphold or Perigee surgeries&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Vaginal anterior wall prolapse greater than or equal to second phase of POP-Q&#xD;
&#xD;
          2. Underwent Uphold or Perigee procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  nil&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei</state>
        <zip>22050</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Far Eastern Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Sheng-Mou Hsiao</investigator_full_name>
    <investigator_title>Chief, Department of Obstetrics &amp; Gynecology</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT03764891
org study id: 107159-E
nct id: NCT03764891
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women.

      The aim of this study was to compare the clinical outcomes of Uphold system and Perigee
      system in treating women with cystocele.
Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women.
      Traditional vaginal surgery with native tissue is associated with high recurrence rate. Thus,
      synthetic meshes were introduced into POP surgery and became the mainstream. Several
      transvaginal mesh procedures, such as Uphold system (Boston Scientific) and Perigee system
      (American Medical Systems Inc), have been used for cystocele repair. Perigee system is a
      trans-obturator four-arm mesh device attached to proximal and distal arcus tendineus fasciae
      pelvis. Nonetheless, Uphold system, is a single incised, two-arm anterior sacrospinous mesh
      fixation system. Both systems can be used for cystocele repair, despite Uphold system can be
      used for concomitant repair of apical prolapse. The aim of this study was to compare the
      clinical outcomes of Uphold system and Perigee system in treating women with cystocele.
observational model: Case-Control
time perspective: Retrospective
measure: Recurrence rate of pelvic organ prolapse
time frame: 10 year
description: Compare the recurrence rate of Uphold system and Perigee system in treating women with cystocele.
measure: Complication rate
time frame: 10 years
description: Compare the complication rate (such as mesh extrusion, dyspareunia, pelvic pain, voiding difficult, etc) of Uphold system and Perigee system in treating women with cystocele.
arm group label: Uphold
description: Patients who underwent Uphold procedure
arm group label: Perigee
description: Patients who underwent Perigee procedure
intervention type: Procedure
intervention name: Uphold
description: Uphold system in treating women with cystocele
arm group label: Uphold
intervention type: Procedure
intervention name: Perigee
description: Perigee system in treating women with cystocele
arm group label: Perigee
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Sheng-Mou Hsiao
investigator title: Chief, Department of Obstetrics & Gynecology
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse