<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/NCT02248935</url>
  </required_header>
  <id_info>
    <org_study_id>599819-2</org_study_id>
    <nct_id>NCT02248935</nct_id>
  </id_info>
  <brief_title>Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy</brief_title>
  <official_title>Prospective Cohort Study Comparing Two Lightweight Y Meshes After Robotic-Assisted Laparoscopic Sacrocolpopexy Longterm Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Atlantic Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Atlantic Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse&#xD;
      from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y&#xD;
      smartmesh lightweight mesh.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Cure Rate</measure>
    <time_frame>5-6 years</time_frame>
    <description>To be considered a &quot;clinical cure&quot; subjects must meet all of the following criteria: no re-operation for or non-surgical treatment of pelvic organ prolapse since the index surgery; no symptoms of vaginal bulge as measured by a validated symptom questionnaire; no Pelvic Organ Prolapse Quantification (POP-Q) points greater than 0; POP-Q point C less than or equal to -5; an answer of &quot;satisfied&quot; or &quot;very satisfied&quot; on validated Surgical Satisfaction Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Anatomic Outcome</measure>
    <time_frame>5-6 year</time_frame>
    <description>POP-Q measurements of Pelvic Organ Prolapse will be measured comparing both mesh groups and entire combined cohort compared to 12 month findings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mesh exposure/erosion</measure>
    <time_frame>5-6 years</time_frame>
    <description>The rate of mesh exposure or erosion will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>5-6 years</time_frame>
    <description>any other complications related to the index surgery will be documented</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Comparison</measure>
    <time_frame>5-6 years</time_frame>
    <description>to compare related symptoms such as urinary frequency, bowel function, and sexual function both between mesh groups and for the entire group compared to 12 month findings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Satisfaction</measure>
    <time_frame>5-6 years</time_frame>
    <description>The validated Surgical Satisfaction Questionnaire will be used to measure overall surgical satisfaction</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">316</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Repair with Alyte or Restorelle Y-Mesh</arm_group_label>
    <description>Women who underwent their index robotic-assisted laparoscopic sacrocolpopexy at Morristown Medical Center or Overlook Medical Center using either the Alyte Y-mesh or Restorelle Y-smartmesh between 1/2007 and 8/2011.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women who had a robotic-assisted laparoscopic sacrocolpopexy using either mentioned Y-mesh&#xD;
        during the listed timeframe. All of the index cases were performed by fellowship-trained&#xD;
        FPMRS specialists.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who underwent robotic-assisted laparoscopic sacrocolpopexy between&#xD;
             January 2007 to August 2011 using either Alyte Y-mesh or Restorelle Y-mesh&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in our long-term outcome study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Urogynecology-Atlantic Health System</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>June 8, 2017</last_update_submitted>
  <last_update_submitted_qc>June 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Robotic Assisted Laparoscopic Sacrocolpopexy</keyword>
  <keyword>Y Mesh</keyword>
  <keyword>Pelvic Organ Prolapse</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>
  <!-- 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/NCT02248935
org study id: 599819-2
nct id: NCT02248935
lead sponsor: 
has dmc: No
The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse
      from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y
      smartmesh lightweight mesh.
observational model: Cohort
time perspective: Prospective
measure: Clinical Cure Rate
time frame: 5-6 years
description: To be considered a "clinical cure" subjects must meet all of the following criteria: no re-operation for or non-surgical treatment of pelvic organ prolapse since the index surgery; no symptoms of vaginal bulge as measured by a validated symptom questionnaire; no Pelvic Organ Prolapse Quantification (POP-Q) points greater than 0; POP-Q point C less than or equal to -5; an answer of "satisfied" or "very satisfied" on validated Surgical Satisfaction Questionnaire
measure: Objective Anatomic Outcome
time frame: 5-6 year
description: POP-Q measurements of Pelvic Organ Prolapse will be measured comparing both mesh groups and entire combined cohort compared to 12 month findings
measure: Mesh exposure/erosion
time frame: 5-6 years
description: The rate of mesh exposure or erosion will be measured
measure: Complications
time frame: 5-6 years
description: any other complications related to the index surgery will be documented
measure: Symptom Comparison
time frame: 5-6 years
description: to compare related symptoms such as urinary frequency, bowel function, and sexual function both between mesh groups and for the entire group compared to 12 month findings
measure: Surgical Satisfaction
time frame: 5-6 years
description: The validated Surgical Satisfaction Questionnaire will be used to measure overall surgical satisfaction
arm group label: Repair with Alyte or Restorelle Y-Mesh
description: Women who underwent their index robotic-assisted laparoscopic sacrocolpopexy at Morristown Medical Center or Overlook Medical Center using either the Alyte Y-mesh or Restorelle Y-smartmesh between 1/2007 and 8/2011.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse