<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/NCT03296748</url>
  </required_header>
  <id_info>
    <org_study_id>151115</org_study_id>
    <nct_id>NCT03296748</nct_id>
  </id_info>
  <brief_title>Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence</brief_title>
  <official_title>Is There Any Value of Concomitant Repair of Asymptomatic Grade II Anterior Vaginal Wall Prolapse During Mid Urethral Sling Surgery for Stress Urinary Incontinence ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</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>
      The aim of our study is to assess the value of concomitant surgical correction of&#xD;
      asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling&#xD;
      for treatment of female patients with stress incontinence&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal&#xD;
      wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and&#xD;
      group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy .</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cure rate of stress incontinence</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>by clinical assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Denovo urgency</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>by clinical assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cure rate of stress incontinence</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>by clinical assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cure rate of stress incontinence</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>by clinical assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Denovo urgency</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>by clinical assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Denovo urgency</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>by clinical assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>TOT only group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>60 patients with stress incontinence and asymptomatic grade 2 cystocele.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>concomitant repair group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>63 patients with stress incontinence and asymptomatic grade 2 cystocele.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>trans-obturator tape inside-out usingsoft tapes.</intervention_name>
    <description>trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.</description>
    <arm_group_label>TOT only group</arm_group_label>
    <arm_group_label>concomitant repair group</arm_group_label>
    <other_name>anterior colporrhaphy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>anterior colporraphy</intervention_name>
    <arm_group_label>concomitant repair group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female patients&#xD;
&#xD;
          -  genuine stress incontinence&#xD;
&#xD;
               -  asymptomatic cystocele&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mixed incontinence&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>23 Years</minimum_age>
    <maximum_age>56 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kasr El Ainiy Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 23, 2017</last_update_submitted>
  <last_update_submitted_qc>October 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>sarah mohamed hassan</investigator_full_name>
    <investigator_title>lecturer of obstetrics and gynecology Cairo university</investigator_title>
  </responsible_party>
  <keyword>asymptomatic cystocele.</keyword>
  <keyword>stress urinary incontinence</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 Incontinence, Stress</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/NCT03296748
org study id: 151115
nct id: NCT03296748
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of our study is to assess the value of concomitant surgical correction of
      asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling
      for treatment of female patients with stress incontinence
female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal
      wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and
      group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy .
primary purpose: Treatment
masking: None (Open Label)
measure: cure rate of stress incontinence
time frame: 3 months after surgery
description: by clinical assessment
measure: Denovo urgency
time frame: 3 months after surgery
description: by clinical assessment
measure: cure rate of stress incontinence
time frame: 6 months after surgery
description: by clinical assessment
measure: cure rate of stress incontinence
time frame: 12 months after surgery
description: by clinical assessment
measure: Denovo urgency
time frame: 6 months after surgery
description: by clinical assessment
measure: Denovo urgency
time frame: 12 months after surgery
description: by clinical assessment
arm group label: TOT only group
arm group type: Active Comparator
description: 60 patients with stress incontinence and asymptomatic grade 2 cystocele.
arm group label: concomitant repair group
arm group type: Active Comparator
description: 63 patients with stress incontinence and asymptomatic grade 2 cystocele.
intervention type: Procedure
intervention name: trans-obturator tape inside-out usingsoft tapes.
description: trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.
arm group label: TOT only group
arm group label: concomitant repair group
other name: anterior colporrhaphy
intervention type: Procedure
intervention name: anterior colporraphy
arm group label: concomitant repair group
criteria: 
gender: Female
minimum age: 23 Years
maximum age: 56 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: sarah mohamed hassan
investigator title: lecturer of obstetrics and gynecology Cairo university
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress