<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/NCT04481906</url>
  </required_header>
  <id_info>
    <org_study_id>CGH-P100072</org_study_id>
    <nct_id>NCT04481906</nct_id>
  </id_info>
  <brief_title>Vaginal Mesh Procedures for Female Cystocele</brief_title>
  <official_title>Long-term Follow-up of Vaginal Mesh Procedures for Female Cystocele</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cathay General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cathay General Hospital</source>
  <brief_summary>
    <textblock>
      This study aimed to evaluate primarily the functional outcomes and secondly the morphological&#xD;
      outcomes for women who had received standard managements for cystocele at mediate-term&#xD;
      follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pelvic organ prolapsed (POP) is an important health issue for women all over the world, with&#xD;
      cystocele being the commonest type of POP. The side effects related to cystocele include&#xD;
      voiding dysfunction, urinary retention, urinary tract infection, hydroureter, or&#xD;
      hydronephrosis. The management for cystocele can be classified as non-surgical and surgical&#xD;
      methods. Non-surgical methods comprise pelvic floor muscle exercise and vaginal pessaries,&#xD;
      while surgical methods can be divided as conventional operations and operations applying mesh&#xD;
      augmentation. Conventional surgeries for cystocele such as anterior colporrhapy have high&#xD;
      surgical failure rates and complications including vaginal shortening or vaginal stenosis.&#xD;
      Operations applying mesh augmentation are becoming the mainstream in the surgeries for&#xD;
      cystocle. The Perigee System (American Medical Systems, Minnetonka, MN, USA), which has been&#xD;
      approved by American FDA and Taiwan DOH in treating female cystocele, have promising&#xD;
      short-term surgical outcomes. However, long-term reports incorporating both functional and&#xD;
      morphological outcomes are lacking in the literatures. This study aimed to evaluate primarily&#xD;
      the functional outcomes and secondly the morphological outcomes for women who had received&#xD;
      standard managements for cystocele at mediate-term follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 25, 2011</start_date>
  <completion_date type="Actual">October 5, 2014</completion_date>
  <primary_completion_date type="Actual">June 16, 2012</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>POP-Q Ba point</measure>
    <time_frame>Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly</time_frame>
    <description>POP-Q Ba &gt; II POP-Q stage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional and ultrasound manifestations</measure>
    <time_frame>Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly</time_frame>
    <description>Urinary incontinence, overactive bladder symptoms, voiding dysfunction, bladder neck position on ultrasound</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>Cystocele</condition>
  <arm_group>
    <arm_group_label>Women 20 years and older with cystocele</arm_group_label>
    <description>Women 20 years and older with cystocele</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vaginal mesh for female cystocele</intervention_name>
    <description>Vaginal mesh procedures (e.g. Perigee) were susgested for women with POP-Q stage III or more cystocele</description>
    <arm_group_label>Women 20 years and older with cystocele</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women 20 years or older with cystocele&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of cystocele&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or possibility of future pregnancy&#xD;
&#xD;
          -  Urinary tract infection&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Neurological diseases&#xD;
&#xD;
          -  Cardiovascular diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>240 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cathay General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10630</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 16, 2018</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cystocele</keyword>
  <keyword>pelvic floor muscle exercise</keyword>
  <keyword>anterior vaginal repair</keyword>
  <keyword>vaginal mesh</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystocele</mesh_term>
    <mesh_term>Hernia</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/NCT04481906
org study id: CGH-P100072
nct id: NCT04481906
lead sponsor: 
This study aimed to evaluate primarily the functional outcomes and secondly the morphological
      outcomes for women who had received standard managements for cystocele at mediate-term
      follow-up.
Pelvic organ prolapsed (POP) is an important health issue for women all over the world, with
      cystocele being the commonest type of POP. The side effects related to cystocele include
      voiding dysfunction, urinary retention, urinary tract infection, hydroureter, or
      hydronephrosis. The management for cystocele can be classified as non-surgical and surgical
      methods. Non-surgical methods comprise pelvic floor muscle exercise and vaginal pessaries,
      while surgical methods can be divided as conventional operations and operations applying mesh
      augmentation. Conventional surgeries for cystocele such as anterior colporrhapy have high
      surgical failure rates and complications including vaginal shortening or vaginal stenosis.
      Operations applying mesh augmentation are becoming the mainstream in the surgeries for
      cystocle. The Perigee System (American Medical Systems, Minnetonka, MN, USA), which has been
      approved by American FDA and Taiwan DOH in treating female cystocele, have promising
      short-term surgical outcomes. However, long-term reports incorporating both functional and
      morphological outcomes are lacking in the literatures. This study aimed to evaluate primarily
      the functional outcomes and secondly the morphological outcomes for women who had received
      standard managements for cystocele at mediate-term follow-up.
observational model: Cohort
time perspective: Prospective
measure: POP-Q Ba point
time frame: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly
description: POP-Q Ba > II POP-Q stage
measure: Functional and ultrasound manifestations
time frame: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly
description: Urinary incontinence, overactive bladder symptoms, voiding dysfunction, bladder neck position on ultrasound
arm group label: Women 20 years and older with cystocele
description: Women 20 years and older with cystocele
intervention type: Procedure
intervention name: Vaginal mesh for female cystocele
description: Vaginal mesh procedures (e.g. Perigee) were susgested for women with POP-Q stage III or more cystocele
arm group label: Women 20 years and older with cystocele
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 240 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Cystocele
mesh term: Hernia