<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/NCT02255994</url>
  </required_header>
  <id_info>
    <org_study_id>LOCAL/2013/RdeT-01</org_study_id>
    <secondary_id>2013-A01705-40</secondary_id>
    <nct_id>NCT02255994</nct_id>
  </id_info>
  <brief_title>UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse</brief_title>
  <acronym>PRO-CURE II</acronym>
  <official_title>Comparison of Long-term Results of UGYTEX® Sub-bladder Mesh Placed Via a Transvaginal Transobturator Approach Versus Subvesical Plication Without Reinforcement in the Surgical Treatment of Bladder Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse&#xD;
      recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE&#xD;
      I.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Secondary objectives include comparing the following elements between the two randomized&#xD;
      groups at a long-term time point (5-8 years):&#xD;
&#xD;
      A. The anatomic failure rate of cystocele (POP-Q stage &gt; or = 2) B. Late postoperative&#xD;
      morbidity C. Residual post-operative pain (visual analog scale (VAS)) D. Patient satisfaction&#xD;
      via the PGI-I questionnaire E. Quality of life via the PFDI and PFIQ questionnaires F. Sexual&#xD;
      activity via the PISQ-12 questionnaire G. The rate of vaginal erosion H. Displacement and&#xD;
      secondary shrinkage of meshs&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional failure</measure>
    <time_frame>5 years</time_frame>
    <description>The primary efficacy endpoint of this study, is the functional failure at 5 years, defined using the functional response at 12 months in NCT00153257, the concept of surgery for prolapse and the answer to question No. 5 of the PFDI questionnaire submitted between 5 and 8 years postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anatomical failure</measure>
    <time_frame>5-8 years</time_frame>
    <description>The anatomical failure is defined by a failure or recurrence at 12 months (data from NCT00153257), or surgery for prolapse or anatomic recurrence (recurrence of cystocele stage 2 or higher) upon examination at 5 to 8 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>5-8 years</time_frame>
    <description>Major complications include surgery for prolapse repair, re-hospitalization or functional complications. Minor complications include all adverse events that are not major complications. Mesh-specific complications include vaginal pain, vaginal erosions, displacement and retraction of the mesh.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The PGI-I questionnaire</measure>
    <time_frame>5-8 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The PFDI questionnaire</measure>
    <time_frame>5-8 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The PFIQ questionnaire</measure>
    <time_frame>5-8 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The PISQ-12 questionnaire</measure>
    <time_frame>5-8 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Cystocele</condition>
  <arm_group>
    <arm_group_label>UGYTEX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No MESH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm had subvesical plication without reinforcement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UGYTEX</intervention_name>
    <description>Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)</description>
    <arm_group_label>UGYTEX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No mesh.</intervention_name>
    <description>Patients in this arm had subvesical plication without reinforcement.</description>
    <arm_group_label>No MESH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have given her informed and signed consent&#xD;
&#xD;
          -  The patient must be insured or beneficiary of a health insurance plan&#xD;
&#xD;
          -  Patient included in, randomized and analysed in the PROCURE study (NCT00153257)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient is under judicial protection, under tutorship or curatorship&#xD;
&#xD;
          -  The patient refuses to sign the consent&#xD;
&#xD;
          -  It is impossible to correctly inform the patient&#xD;
&#xD;
          -  Patient not included in the PROCURE study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renaud de Tayrac, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Centre Hospitalier Universitaire de Nîmes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Champeau</name>
      <address>
        <city>Béziers</city>
        <zip>34500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP - Hôpital Antoine Beclere</name>
      <address>
        <city>Clamart Cedex</city>
        <zip>92141</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont Ferrand - Hôpital Estaing</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP - Hôpital Beaujon</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH d'Issoire - Centre Hospitalier Paul Ardier</name>
      <address>
        <city>Issoire</city>
        <zip>63503</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de la Rochelle</name>
      <address>
        <city>La Rochelle Cedex</city>
        <zip>17019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Chartres - Hôpital Louis Pasteur</name>
      <address>
        <city>Le Coudray</city>
        <zip>28630</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP - Centre Hospitalier Universitaire de Bicêtre</name>
      <address>
        <city>Le Kremlin Bicêtre Cedex</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Nîmes - Hôpital Universitaire Carémeau</name>
      <address>
        <city>Nîmes Cedex 09</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH d'Orange - Hôpital Louis Giorgi</name>
      <address>
        <city>Orange</city>
        <zip>84106</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Mutualiste La Sagesse</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen - Hôpital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>February 5, 2016</last_update_submitted>
  <last_update_submitted_qc>February 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystocele</mesh_term>
    <mesh_term>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/NCT02255994
org study id: LOCAL/2013/RdeT-01
secondary id: 2013-A01705-40
nct id: NCT02255994
lead sponsor: 
has dmc: No
The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse
      recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE
      I.
Secondary objectives include comparing the following elements between the two randomized
      groups at a long-term time point (5-8 years):

      A. The anatomic failure rate of cystocele (POP-Q stage > or = 2) B. Late postoperative
      morbidity C. Residual post-operative pain (visual analog scale (VAS)) D. Patient satisfaction
      via the PGI-I questionnaire E. Quality of life via the PFDI and PFIQ questionnaires F. Sexual
      activity via the PISQ-12 questionnaire G. The rate of vaginal erosion H. Displacement and
      secondary shrinkage of meshs
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functional failure
time frame: 5 years
description: The primary efficacy endpoint of this study, is the functional failure at 5 years, defined using the functional response at 12 months in NCT00153257, the concept of surgery for prolapse and the answer to question No. 5 of the PFDI questionnaire submitted between 5 and 8 years postoperatively.
measure: Anatomical failure
time frame: 5-8 years
description: The anatomical failure is defined by a failure or recurrence at 12 months (data from NCT00153257), or surgery for prolapse or anatomic recurrence (recurrence of cystocele stage 2 or higher) upon examination at 5 to 8 years.
measure: Post-operative complications
time frame: 5-8 years
description: Major complications include surgery for prolapse repair, re-hospitalization or functional complications. Minor complications include all adverse events that are not major complications. Mesh-specific complications include vaginal pain, vaginal erosions, displacement and retraction of the mesh.
measure: The PGI-I questionnaire
time frame: 5-8 years
measure: The PFDI questionnaire
time frame: 5-8 years
measure: The PFIQ questionnaire
time frame: 5-8 years
measure: The PISQ-12 questionnaire
time frame: 5-8 years
arm group label: UGYTEX
arm group type: Experimental
description: Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
arm group label: No MESH
arm group type: Active Comparator
description: Patients in this arm had subvesical plication without reinforcement.
intervention type: Device
intervention name: UGYTEX
description: Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
arm group label: UGYTEX
intervention type: Procedure
intervention name: No mesh.
description: Patients in this arm had subvesical plication without reinforcement.
arm group label: No MESH
criteria: 
gender: Female
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Renaud de Tayrac, MD, PhD
role: Study Director
affiliation: Centre Hospitalier Universitaire de Nîmes
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Cystocele
mesh term: Prolapse