<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/NCT04506177</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00036663</org_study_id>
    <nct_id>NCT04506177</nct_id>
  </id_info>
  <brief_title>Permanent Versus Delayed-Absorbable Monofilament Suture</brief_title>
  <acronym>E-PACT</acronym>
  <official_title>E-PACT: Extension Trial of Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</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>
      This is an extension study of a prospective, multicenter, randomized, single-blind trial&#xD;
      whose purpose is to compare mesh-related complications and effectiveness of pelvic organ&#xD;
      prolapse (POP) repair in women undergoing minimally-invasive total hysterectomy and&#xD;
      sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent&#xD;
      (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (polydioxanone,&#xD;
      PDS) suture for vaginal mesh attachment through at least 3 years after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an extension study of a randomized controlled trial that will be conducted at the&#xD;
      same 5 clinical sites as the primary study - All subjects who participated in the original&#xD;
      randomization and did not withdraw from the study are eligible for the extension study&#xD;
      including those with a history of secondary treatment following PACT RCT study participation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Vaginal Mesh or Suture Exposure</measure>
    <time_frame>Post Procedure Evaluation at Minimum 2 years</time_frame>
    <description>Total number of participants (96% with permanent and 86% absorbable suture) will be examined and evaluated for vaginal mesh and/or suture exposure at 2 years or grater time period. Exposure of the suture or mesh will be defined upon the visual examination in the clinic, It is expected to identify &lt;10% patient population during examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vaginal Mesh or Suture Exposure</measure>
    <time_frame>Post Procedure Evaluation at 3 years</time_frame>
    <description>Total number of participants (96% with permanent and 86% absorbable suture) will be examined and evaluated for vaginal mesh and/or suture exposure at 3 years or grater time period. Exposure of the suture or mesh will be defined upon the visual examination in the clinic, It is expected to identify &lt;10% patient population during examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anatomic success</measure>
    <time_frame>Post Procedure Evaluation at Minimum 2 years and 3 years</time_frame>
    <description>Leading edge of the prolapse is at or above the hymen to be evaluate among expected 200 participants. POP-Q assessment will be performed with surgical success being defined as apical descent less than 50% of total vaginal length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective success</measure>
    <time_frame>Post Procedure Evaluation at Minimum 2 years and 3 years</time_frame>
    <description>PFDI-20 (Pelvic Floor Disability Index) - Patient denies symptoms of vaginal bulging per question 3, answering &quot;No&quot; or &quot;Yes&quot;. Response &quot;Yes&quot; leads to 4 probabilities of bothersome of condition from none to quite a bit (3 scales of symptoms and 0 as &quot;Not at all&quot;). Higher the value indicates a greater degree of bother. It is expected to have &lt;10% to have bulge symptoms by the end of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment for re-intervention or re-surgery for recurrence of persistence of POP</measure>
    <time_frame>Post Procedure Evaluation at Minimum 2 years and 3 years</time_frame>
    <description>No necessary use or additional surgical treatment for prolapse at any time after the initial procedure among expected 200 participants who have had participated in the original PACT study trial. Usage of pessary will be accounted as retreatment with expected &lt;1% patient population.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Hysterectomy</condition>
  <condition>Sacrocolpopexy</condition>
  <arm_group>
    <arm_group_label>Permanent Sutures</arm_group_label>
    <description>Women who previously received (in the PACT Study Trial) minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) suture for vaginal mesh attachment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Absorbable Monofilament Sutures</arm_group_label>
    <description>Women who previously received (in the PACT Study Trial) minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using delayed absorbable monofilament (polydioxanone, PDS) suture for vaginal mesh attachment</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Study Patients who have participated in the PACT Study Trial at one of the following&#xD;
        Research Sites:&#xD;
&#xD;
          1. Wake Forest University, Winston-Salem (22 subject participants)&#xD;
&#xD;
          2. University of North Carolina, Chapel Hill&#xD;
&#xD;
          3. Northwestern Medical Center, Chicago&#xD;
&#xD;
          4. Augusta University, Augusta&#xD;
&#xD;
          5. Atrium Health, Charlotte&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have participated in the PACT Study Trial (Permanent Versus&#xD;
             Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During&#xD;
             Minimally-invasive Total Hysterectomy and Sacrocolpopexy: A Randomized Clinical Trial)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is not willing to sign consent&#xD;
&#xD;
          -  Patient does not want to fill-out questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients with the history of hysterectomy and sacrocolpopexy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine A Matthews, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atrium Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pelvic Organ Prolapse</keyword>
  <keyword>Vaginal mesh</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/NCT04506177
org study id: IRB00036663
nct id: NCT04506177
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is an extension study of a prospective, multicenter, randomized, single-blind trial
      whose purpose is to compare mesh-related complications and effectiveness of pelvic organ
      prolapse (POP) repair in women undergoing minimally-invasive total hysterectomy and
      sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent
      (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (polydioxanone,
      PDS) suture for vaginal mesh attachment through at least 3 years after surgery.
This is an extension study of a randomized controlled trial that will be conducted at the
      same 5 clinical sites as the primary study - All subjects who participated in the original
      randomization and did not withdraw from the study are eligible for the extension study
      including those with a history of secondary treatment following PACT RCT study participation.
observational model: Cohort
time perspective: Prospective
measure: Vaginal Mesh or Suture Exposure
time frame: Post Procedure Evaluation at Minimum 2 years
description: Total number of participants (96% with permanent and 86% absorbable suture) will be examined and evaluated for vaginal mesh and/or suture exposure at 2 years or grater time period. Exposure of the suture or mesh will be defined upon the visual examination in the clinic, It is expected to identify <10% patient population during examination
measure: Vaginal Mesh or Suture Exposure
time frame: Post Procedure Evaluation at 3 years
description: Total number of participants (96% with permanent and 86% absorbable suture) will be examined and evaluated for vaginal mesh and/or suture exposure at 3 years or grater time period. Exposure of the suture or mesh will be defined upon the visual examination in the clinic, It is expected to identify <10% patient population during examination
measure: Anatomic success
time frame: Post Procedure Evaluation at Minimum 2 years and 3 years
description: Leading edge of the prolapse is at or above the hymen to be evaluate among expected 200 participants. POP-Q assessment will be performed with surgical success being defined as apical descent less than 50% of total vaginal length
measure: Subjective success
time frame: Post Procedure Evaluation at Minimum 2 years and 3 years
description: PFDI-20 (Pelvic Floor Disability Index) - Patient denies symptoms of vaginal bulging per question 3, answering "No" or "Yes". Response "Yes" leads to 4 probabilities of bothersome of condition from none to quite a bit (3 scales of symptoms and 0 as "Not at all"). Higher the value indicates a greater degree of bother. It is expected to have <10% to have bulge symptoms by the end of the study.
measure: Assessment for re-intervention or re-surgery for recurrence of persistence of POP
time frame: Post Procedure Evaluation at Minimum 2 years and 3 years
description: No necessary use or additional surgical treatment for prolapse at any time after the initial procedure among expected 200 participants who have had participated in the original PACT study trial. Usage of pessary will be accounted as retreatment with expected <1% patient population.
arm group label: Permanent Sutures
description: Women who previously received (in the PACT Study Trial) minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) suture for vaginal mesh attachment
arm group label: Delayed Absorbable Monofilament Sutures
description: Women who previously received (in the PACT Study Trial) minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using delayed absorbable monofilament (polydioxanone, PDS) suture for vaginal mesh attachment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female patients with the history of hysterectomy and sacrocolpopexy
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine A Matthews, MD
role: Principal Investigator
affiliation: Wake Forest Health Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No