<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/NCT04429360</url>
  </required_header>
  <id_info>
    <org_study_id>EDGE000835</org_study_id>
    <nct_id>NCT04429360</nct_id>
  </id_info>
  <brief_title>What is the Effect of Prolapse Surgery on Voiding?</brief_title>
  <acronym>PROVOID</acronym>
  <official_title>What is the Effect of Prolapse Surgery on Voiding?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiteit Antwerpen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study is to examine the effect of prolapse surgery on voiding. Our study is&#xD;
      the very first one to combine several innovative low-invasive and low-cost methods to analyse&#xD;
      the amelioration or deterioration of voiding function after surgery for pelvic organ prolapse&#xD;
      using 3D/4D translabial ultrasound, home-uroflowmetry and patient reported quality of life&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">June 8, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 8, 2022</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>Change in lower urinary tract symptoms pre- postoperatively</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>Voiding diary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lower urinary tract symptoms pre- postoperatively</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>Questionnaire: PFDI-20</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in clinical outcome measures</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>POP-Q</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in clinical outcome measures</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>Transperineal ultrasound (TPUS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in voiding</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>home-uroflowmetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QoL</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>Questionnaire: PFIQ-7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QoL</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>Questionnaire: PISQ-12</description>
  </secondary_outcome>
  <enrollment type="Anticipated">453</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Stress Urinary Incontinence</condition>
  <condition>Overactive Bladder</condition>
  <condition>Voiding Disorders</condition>
  <condition>Urge Incontinence</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pelvic reconstructive surgery</intervention_name>
    <description>Pelvic reconstructive surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women attending a gynecological unit with symptoms of pelvic organ prolapse and who will&#xD;
        undergo pelvic floor surgery as management of their symptoms.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥18 years&#xD;
&#xD;
          -  Dutch, French or English- speaking women&#xD;
&#xD;
          -  symptoms of pelvic organ prolapse&#xD;
&#xD;
          -  preoperatively pelvic floor surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - history of neurological disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sascha Vereeck, Dr.</last_name>
    <phone>003238215945</phone>
    <email>saschavereeck@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital of Antwerp</name>
      <address>
        <city>Edegem</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sascha Vereeck, Dr.</last_name>
      <phone>003238215945</phone>
      <email>saschavereeck@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiteit Antwerpen</investigator_affiliation>
    <investigator_full_name>Prof Yves Jacquemyn</investigator_full_name>
    <investigator_title>Head of Department Gynecology, UZA</investigator_title>
  </responsible_party>
  <keyword>Pelvic Organ Prolapse</keyword>
  <keyword>Surgery</keyword>
  <keyword>3D/4D imaging</keyword>
  <keyword>urinary incontinence</keyword>
  <keyword>voiding dysfunction</keyword>
  <keyword>patient reported outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
    <mesh_term>Urinary Incontinence, Urge</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <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/NCT04429360
org study id: EDGE000835
nct id: NCT04429360
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of our study is to examine the effect of prolapse surgery on voiding. Our study is
      the very first one to combine several innovative low-invasive and low-cost methods to analyse
      the amelioration or deterioration of voiding function after surgery for pelvic organ prolapse
      using 3D/4D translabial ultrasound, home-uroflowmetry and patient reported quality of life
      outcomes.
observational model: Cohort
time perspective: Prospective
measure: Change in lower urinary tract symptoms pre- postoperatively
time frame: 1 year follow-up
description: Voiding diary
measure: Change in lower urinary tract symptoms pre- postoperatively
time frame: 1 year follow-up
description: Questionnaire: PFDI-20
measure: Change in clinical outcome measures
time frame: 1 year follow-up
description: POP-Q
measure: Change in clinical outcome measures
time frame: 1 year follow-up
description: Transperineal ultrasound (TPUS)
measure: Change in voiding
time frame: 1 year follow-up
description: home-uroflowmetry
measure: Change in QoL
time frame: 1 year follow-up
description: Questionnaire: PFIQ-7
measure: Change in QoL
time frame: 1 year follow-up
description: Questionnaire: PISQ-12
intervention type: Procedure
intervention name: pelvic reconstructive surgery
description: Pelvic reconstructive surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sascha Vereeck, Dr.
phone: 003238215945
email: saschavereeck@hotmail.com
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universiteit Antwerpen
investigator full name: Prof Yves Jacquemyn
investigator title: Head of Department Gynecology, UZA
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Bladder, Overactive
mesh term: Urinary Incontinence, Stress
mesh term: Urinary Incontinence, Urge
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No