<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/NCT02231099</url>
  </required_header>
  <id_info>
    <org_study_id>VROUW2</org_study_id>
    <nct_id>NCT02231099</nct_id>
  </id_info>
  <brief_title>Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery</brief_title>
  <acronym>VROUW2</acronym>
  <official_title>A Prospective and Comparative Study of the (Cost)Effectiveness Preformance of Tension Free Vaginal Mesh Plus Monocryl (Prolift+M) Versus Conventional Vaginal Prolaps Surgery in Primary Pelvic Organ Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of&#xD;
      pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for&#xD;
      improvement of the surgical techniques currently used. Placement of a mesh aims at reducing&#xD;
      the recurrence rate.&#xD;
&#xD;
      In this study the investigators compare the effectiveness of the Tension free Vaginal mesh +&#xD;
      Monocryl with standard vaginal prolapse surgery without mesh.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Pelvic organ prolapse is highly prevalent in the female population. The incidence&#xD;
      of pelvic organ prolapse increases with age, so the longer life expectancy of women may cause&#xD;
      pelvic organ prolapse to become an even more major health issue. The recurrence rate of&#xD;
      pelvic organ prolapse after surgical treatment is high. The recurrence rate of the anterior&#xD;
      vaginal wall prolapse after an anterior colporrhaphy is 30%-45%. The posterior vaginal wall&#xD;
      prolapse recurrence rate after a posterior colporrhaphy is 12-25%. This emphasizes the&#xD;
      clinical need for improvement of the surgical techniques currently used. Placement of a mesh&#xD;
      aims at reducing the recurrence rate (2-11%).&#xD;
&#xD;
      Objective: To compare the clinical and cost effectiveness of the Tension free Vaginal Mesh +&#xD;
      Monocryl (Prolift+M) with the standard vaginal prolapse surgery (i.e. fascial placation). A&#xD;
      secondary objective is to track the post-operative and long-term complications of both&#xD;
      procedures. A third objective is to evaluate recovery after surgery.&#xD;
&#xD;
      Study design: a prospective, multicentre, randomized, non-blinded study between Tension free&#xD;
      Vaginal Mesh + Monocryl (Prolift+MTM) and standard vaginal prolapse surgery (i.e. fascial&#xD;
      placation).&#xD;
&#xD;
      Study population: women with a primary pelvic organ prolapse of the anterior and/or posterior&#xD;
      compartment POP stage II or more, in the age of 45 years or older.&#xD;
&#xD;
      Intervention (if applicable): Prolapse surgery with tension free vaginal mesh + Monocryl&#xD;
      (Prolift + M) versus conventional vaginal prolapse surgery.&#xD;
&#xD;
      Main study parameters/endpoints: The main outcome is the percentage of patients with&#xD;
      objective anatomical success (POP stage &lt; 2) after 24 months. As secondary outcome the&#xD;
      subjective improvement in quality of life will be measured by generic (EQ-5D,PGI-I) and&#xD;
      disease-specific (UDI, DDI, IIQ and PFDI20) quality of life instrument. Sexual functioning&#xD;
      will be measured by generic (FSFI) and disease specific (PISQ12) questionnaires.&#xD;
      Complications will be monitored with special notice for pain (Mc Gill pain questionnaire)&#xD;
      Recovery will be measured with the Recovery index 10. The economical endpoint is short term&#xD;
      (2 year) incremental cost-effectiveness in terms of costs per additional year free of&#xD;
      prolapse and costs per QALY gained.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: Burden associated with participation: complete a disease specific Quality of&#xD;
      life questionnaire 4 times, complete a recovery index questionnaire 3 times. Visit the&#xD;
      hospital 4 times after the surgery (this is 2 times more often than patients not&#xD;
      participating in the study). Since subjects are selected from subjects already agreeing to&#xD;
      complete a surgical procedure, the additional risks of participation in this study are low.&#xD;
      These risks include tissue erosion (vaginal, rectal or bladder), vaginal pain/dyspareunia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2011</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 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>objective anatomic success (POPQ stage &lt;2)</measure>
    <time_frame>24 months</time_frame>
    <description>clinical investigation including POPQ</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>subjective improvement in quality of life</measure>
    <time_frame>24 months</time_frame>
    <description>Questionnaires; Euroqol5D, PGI-I, UDI, DDI and PFDI20</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sexual function/dysfunction</measure>
    <time_frame>24 months</time_frame>
    <description>PISQ-12, BESAQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>24 months</time_frame>
    <description>clinical investigation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recovery</measure>
    <time_frame>6 weeks</time_frame>
    <description>Recovery Index 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost-effectiveness</measure>
    <time_frame>24 months</time_frame>
    <description>Costs of the strategies Tension free Vaginal mesh+Monocryl as well as standard vaginal prolapse surgery will be estimated using direct medical costs based on the actual costs of the surgery, personnel, material costs and costs for surgery due to recurrence or complications.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">176</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Cystocele</condition>
  <condition>Rectocele</condition>
  <condition>Uterine Prolapse</condition>
  <arm_group>
    <arm_group_label>prolift + m</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>surgery with mesh (prolift+M)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional vaginal prolapse surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional vaginal prolapse surgery; anterior colporrhaphy or posterior colporrhaphy or spinal ligament fixation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Prolift + M</intervention_name>
    <description>prolapse surgery with mesh</description>
    <arm_group_label>prolift + m</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional vaginal prolapse surgery</intervention_name>
    <description>conventional vaginal prolapse surgery;anterior colporrhaphy, posterior colporrhaphy</description>
    <arm_group_label>conventional vaginal prolapse surgery</arm_group_label>
    <other_name>anterior colporrhaphy, posterior colporrhaphy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a anterior and/or posterior prolapse POP-Q stage II or more. Subjects with&#xD;
             a middle compartment prolapse may only be included if there is a co-existing anterior&#xD;
             or posterior defect which needs surgical correction.&#xD;
&#xD;
          -  Subject has agreed to undergo implantation of Prolift+MTM or fascial plication&#xD;
&#xD;
          -  Subject is willing to return for follow-up evaluation and QoL questionnaires&#xD;
             completion at 6weeks, 6 months, 12 months and 24 months follow-ups.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Age &lt; 45 years&#xD;
&#xD;
          -  Subject has had a previous surgery for pelvic organ prolapse. A previous mid-urethral&#xD;
             sling procedure is not an exclusion criterion.&#xD;
&#xD;
          -  Have current urinary tract or vaginal infections&#xD;
&#xD;
          -  Have blood coagulation disorders&#xD;
&#xD;
          -  Have a compromised immune system or any other conditions that would compromise healing&#xD;
&#xD;
          -  Are unwilling or unable to return for evaluation&#xD;
&#xD;
          -  Previous irradiation&#xD;
&#xD;
          -  Presence of any malignancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mariella IJ Withagen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gelre ziekenhuizen Apeldoorn</name>
      <address>
        <city>Apeldoorn</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reinier de Graaf Group</name>
      <address>
        <city>Delft</city>
        <zip>2625 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC St Radboud</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zaans Medisch Centre</name>
      <address>
        <city>Zaandam</city>
        <zip>1500 EE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala clinics</name>
      <address>
        <city>Zwolle</city>
        <zip>8025 AB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>January 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>February 5, 2015</last_update_submitted>
  <last_update_submitted_qc>February 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Radboud University Medical Center</investigator_affiliation>
    <investigator_full_name>Mariella Withagen</investigator_full_name>
    <investigator_title>Dr. M.I.J. Withagen</investigator_title>
  </responsible_party>
  <keyword>recurrent pelvic organ prolapse</keyword>
  <keyword>mesh</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectocele</mesh_term>
    <mesh_term>Cystocele</mesh_term>
    <mesh_term>Uterine Prolapse</mesh_term>
    <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/NCT02231099
org study id: VROUW2
nct id: NCT02231099
lead sponsor: 
has dmc: No
Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of
      pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for
      improvement of the surgical techniques currently used. Placement of a mesh aims at reducing
      the recurrence rate.

      In this study the investigators compare the effectiveness of the Tension free Vaginal mesh +
      Monocryl with standard vaginal prolapse surgery without mesh.
Rationale: Pelvic organ prolapse is highly prevalent in the female population. The incidence
      of pelvic organ prolapse increases with age, so the longer life expectancy of women may cause
      pelvic organ prolapse to become an even more major health issue. The recurrence rate of
      pelvic organ prolapse after surgical treatment is high. The recurrence rate of the anterior
      vaginal wall prolapse after an anterior colporrhaphy is 30%-45%. The posterior vaginal wall
      prolapse recurrence rate after a posterior colporrhaphy is 12-25%. This emphasizes the
      clinical need for improvement of the surgical techniques currently used. Placement of a mesh
      aims at reducing the recurrence rate (2-11%).

      Objective: To compare the clinical and cost effectiveness of the Tension free Vaginal Mesh +
      Monocryl (Prolift+M) with the standard vaginal prolapse surgery (i.e. fascial placation). A
      secondary objective is to track the post-operative and long-term complications of both
      procedures. A third objective is to evaluate recovery after surgery.

      Study design: a prospective, multicentre, randomized, non-blinded study between Tension free
      Vaginal Mesh + Monocryl (Prolift+MTM) and standard vaginal prolapse surgery (i.e. fascial
      placation).

      Study population: women with a primary pelvic organ prolapse of the anterior and/or posterior
      compartment POP stage II or more, in the age of 45 years or older.

      Intervention (if applicable): Prolapse surgery with tension free vaginal mesh + Monocryl
      (Prolift + M) versus conventional vaginal prolapse surgery.

      Main study parameters/endpoints: The main outcome is the percentage of patients with
      objective anatomical success (POP stage < 2) after 24 months. As secondary outcome the
      subjective improvement in quality of life will be measured by generic (EQ-5D,PGI-I) and
      disease-specific (UDI, DDI, IIQ and PFDI20) quality of life instrument. Sexual functioning
      will be measured by generic (FSFI) and disease specific (PISQ12) questionnaires.
      Complications will be monitored with special notice for pain (Mc Gill pain questionnaire)
      Recovery will be measured with the Recovery index 10. The economical endpoint is short term
      (2 year) incremental cost-effectiveness in terms of costs per additional year free of
      prolapse and costs per QALY gained.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Burden associated with participation: complete a disease specific Quality of
      life questionnaire 4 times, complete a recovery index questionnaire 3 times. Visit the
      hospital 4 times after the surgery (this is 2 times more often than patients not
      participating in the study). Since subjects are selected from subjects already agreeing to
      complete a surgical procedure, the additional risks of participation in this study are low.
      These risks include tissue erosion (vaginal, rectal or bladder), vaginal pain/dyspareunia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: objective anatomic success (POPQ stage <2)
time frame: 24 months
description: clinical investigation including POPQ
measure: subjective improvement in quality of life
time frame: 24 months
description: Questionnaires; Euroqol5D, PGI-I, UDI, DDI and PFDI20
measure: sexual function/dysfunction
time frame: 24 months
description: PISQ-12, BESAQ
measure: complications
time frame: 24 months
description: clinical investigation
measure: recovery
time frame: 6 weeks
description: Recovery Index 10
measure: cost-effectiveness
time frame: 24 months
description: Costs of the strategies Tension free Vaginal mesh+Monocryl as well as standard vaginal prolapse surgery will be estimated using direct medical costs based on the actual costs of the surgery, personnel, material costs and costs for surgery due to recurrence or complications.
arm group label: prolift + m
arm group type: Experimental
description: surgery with mesh (prolift+M)
arm group label: conventional vaginal prolapse surgery
arm group type: Active Comparator
description: conventional vaginal prolapse surgery; anterior colporrhaphy or posterior colporrhaphy or spinal ligament fixation
intervention type: Procedure
intervention name: Prolift + M
description: prolapse surgery with mesh
arm group label: prolift + m
intervention type: Procedure
intervention name: conventional vaginal prolapse surgery
description: conventional vaginal prolapse surgery;anterior colporrhaphy, posterior colporrhaphy
arm group label: conventional vaginal prolapse surgery
other name: anterior colporrhaphy, posterior colporrhaphy
criteria: 
gender: Female
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Mariella IJ Withagen, MD, PhD
role: Principal Investigator
affiliation: Radboud Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Radboud University Medical Center
investigator full name: Mariella Withagen
investigator title: Dr. M.I.J. Withagen
mesh term: Rectocele
mesh term: Cystocele
mesh term: Uterine Prolapse
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse