<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/NCT03295487</url>
  </required_header>
  <id_info>
    <org_study_id>Saramohamed7880</org_study_id>
    <nct_id>NCT03295487</nct_id>
  </id_info>
  <brief_title>ToT and Estrogen in Postmenopausal Females</brief_title>
  <official_title>The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the subjective and objective outcomes of TVT-O procedure alone versus the same&#xD;
      procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female&#xD;
      with genuine stress incontinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      a randomized controlled trial comparing the effect of using local estrogen cream after tot in&#xD;
      postmenopausal female&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>outcome of the surgery</measure>
    <time_frame>immediately after surgery</time_frame>
    <description>clinical and urodynamic test improvment of the stress incontinence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>outcome of the surgery</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>clinical and urodynamic test improvment of the stress incontinence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>nocturia ,</measure>
    <time_frame>immediatly after surgery</time_frame>
    <description>symptom and sign from the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency,</measure>
    <time_frame>immediatly after surgery</time_frame>
    <description>symptom and sign from the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>denovo urgency</measure>
    <time_frame>immediatly after surgery</time_frame>
    <description>symptom and sign from the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>denovo urgency</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>symptom and sign from the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nocturia</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>symptom and sign from the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>symptom and sign from the patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <condition>Postmenopausal Disorder</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>post menopausal female with genuine stress incontinence treated by TVT-O only</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TVT-O</intervention_name>
    <description>transobturator tape has been applied to all the patients in the study,and local estrogen vaginal cream is only applied to patients in group A</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <other_name>local vaginal estrogen cream</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -menopause patients included in group A should have: no history of breast cancer, ovarian&#xD;
        cancer or uterine cancer No history of blood clots or thromboembolism No history of heart&#xD;
        disease or stroke No history liver disease. Endometrial thickness less than 5mm Have a&#xD;
        normal mammogram&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of urge or mixed incontinence .&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>49 Years</minimum_age>
    <maximum_age>65 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 2022</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 21, 2022</last_update_submitted>
  <last_update_submitted_qc>October 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</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</investigator_title>
  </responsible_party>
  <keyword>post menopausal stress incontinence</keyword>
  <keyword>local estrogen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estrogens</mesh_term>
  </intervention_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/NCT03295487
org study id: Saramohamed7880
nct id: NCT03295487
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
To compare the subjective and objective outcomes of TVT-O procedure alone versus the same
      procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female
      with genuine stress incontinence.
a randomized controlled trial comparing the effect of using local estrogen cream after tot in
      postmenopausal female
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: outcome of the surgery
time frame: immediately after surgery
description: clinical and urodynamic test improvment of the stress incontinence
measure: outcome of the surgery
time frame: 3 months after surgery
description: clinical and urodynamic test improvment of the stress incontinence
measure: nocturia ,
time frame: immediatly after surgery
description: symptom and sign from the patients
measure: frequency,
time frame: immediatly after surgery
description: symptom and sign from the patients
measure: denovo urgency
time frame: immediatly after surgery
description: symptom and sign from the patients
measure: denovo urgency
time frame: 3 months after surgery
description: symptom and sign from the patients
measure: nocturia
time frame: 3 months after surgery
description: symptom and sign from the patients
measure: frequency
time frame: 3 months after surgery
description: symptom and sign from the patients
arm group label: Group A
arm group type: Active Comparator
description: post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery
arm group label: Group B
arm group type: Active Comparator
description: post menopausal female with genuine stress incontinence treated by TVT-O only
intervention type: Procedure
intervention name: TVT-O
description: transobturator tape has been applied to all the patients in the study,and local estrogen vaginal cream is only applied to patients in group A
arm group label: Group A
arm group label: Group B
other name: local vaginal estrogen cream
criteria: 
gender: Female
minimum age: 49 Years
maximum age: 65 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
mesh term: Urinary Incontinence
mesh term: Urinary Incontinence, Stress
mesh term: Estrogens