<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/NCT03300973</url>
  </required_header>
  <id_info>
    <org_study_id>11279</org_study_id>
    <nct_id>NCT03300973</nct_id>
  </id_info>
  <brief_title>Urodynamic Study and Stress Incontinence</brief_title>
  <official_title>Role of Urodynamic Study Before 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>
      A trial to answer the debatabal question about the role of urodynamic study in surgical&#xD;
      treatment for stress urinary incontinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      group of patients complaining of stress urinary incontinence and candidate for sling surgery&#xD;
      were randomaly divided into 2 groups either to have urodynamic study before surgery or not.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2016</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <phase>Phase 2</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>
  </study_design_info>
  <primary_outcome>
    <measure>cure of stress incontinence</measure>
    <time_frame>1 week after surgery</time_frame>
    <description>by clinical assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cure of stress incontinence</measure>
    <time_frame>one month after surgery</time_frame>
    <description>by clinical assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cure of stress incontinence</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>by clinical assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>urodynamics study group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgery only group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sling surgery</intervention_name>
    <description>transoburator vaginal tape ,inside out procedure under spinal anathesia</description>
    <arm_group_label>surgery only group</arm_group_label>
    <arm_group_label>urodynamics study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stress urinary incontinence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mixed incontinence&#xD;
&#xD;
          -  recurrent cases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sarah M Hassan, lecturer</last_name>
    <phone>01003733671</phone>
    <email>saramohamed7880@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kasr El Ainiy Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>sarah M Hassan, Lecturer</last_name>
      <phone>01003733671</phone>
      <email>saramohamed7880@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 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>urodynamic study</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>
  <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/NCT03300973
org study id: 11279
nct id: NCT03300973
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A trial to answer the debatabal question about the role of urodynamic study in surgical
      treatment for stress urinary incontinence.
group of patients complaining of stress urinary incontinence and candidate for sling surgery
      were randomaly divided into 2 groups either to have urodynamic study before surgery or not.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
measure: cure of stress incontinence
time frame: 1 week after surgery
description: by clinical assessment
measure: cure of stress incontinence
time frame: one month after surgery
description: by clinical assessment
measure: cure of stress incontinence
time frame: 3 months after surgery
description: by clinical assessment
arm group label: urodynamics study group
arm group type: Active Comparator
description: 65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery
arm group label: surgery only group
arm group type: Active Comparator
description: 60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study
intervention type: Procedure
intervention name: sling surgery
description: transoburator vaginal tape ,inside out procedure under spinal anathesia
arm group label: surgery only group
arm group label: urodynamics study group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Sarah M Hassan, lecturer
phone: 01003733671
email: saramohamed7880@yahoo.com
facility: 
status: Recruiting
contact: 
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
sharing ipd: No