<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/NCT03301818</url>
  </required_header>
  <id_info>
    <org_study_id>0300-17-RMB</org_study_id>
    <nct_id>NCT03301818</nct_id>
  </id_info>
  <brief_title>Vaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence.</brief_title>
  <official_title>Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Urinary Stress Incontinence (USI) on Vaginal Elasticity as Measured by Vaginal Tactile Imaging.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <oversight_info>
    <has_dmc>No</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>
      Female patients with USI will be evaluated for vaginal elasticity using vaginal tactile&#xD;
      imaging both before and after surgery for the repair of the USI. Surgical repair will be&#xD;
      performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O)&#xD;
      repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be recruited and sign a consent form. The patients included are patients with&#xD;
      USI that are candidates for a TVT-O repair.&#xD;
&#xD;
      Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different&#xD;
      points:&#xD;
&#xD;
        -  The day of surgery before surgery.&#xD;
&#xD;
        -  The day after surgery.&#xD;
&#xD;
        -  3 months post-operational. Every patient will serve as her own control. Demographic,&#xD;
           gynecologic and obstetric history will be obtained from patients' electronic files.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">July 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaginal elasticity assessment</measure>
    <time_frame>up to 3 months from enrollment</time_frame>
    <description>Vaginal elasticity as measured by the vaginal tactile imager</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Stress Incontinence, Female</condition>
  <arm_group>
    <arm_group_label>Patients undergoing USI repair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vaginal tactile imager</intervention_name>
    <description>Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after during a 3 month interval.</description>
    <arm_group_label>Patients undergoing USI repair</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any woman undergoing USI repair.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with high grade pelvic floor prolapse.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roy Lauterbach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam healthcare campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam health care campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>ROY LAUTERBACH MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03301818
org study id: 0300-17-RMB
nct id: NCT03301818
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Female patients with USI will be evaluated for vaginal elasticity using vaginal tactile
      imaging both before and after surgery for the repair of the USI. Surgical repair will be
      performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O)
      repair.
Patients will be recruited and sign a consent form. The patients included are patients with
      USI that are candidates for a TVT-O repair.

      Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different
      points:

        -  The day of surgery before surgery.

        -  The day after surgery.

        -  3 months post-operational. Every patient will serve as her own control. Demographic,
           gynecologic and obstetric history will be obtained from patients' electronic files.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Vaginal elasticity assessment
time frame: up to 3 months from enrollment
description: Vaginal elasticity as measured by the vaginal tactile imager
arm group label: Patients undergoing USI repair
arm group type: Experimental
intervention type: Device
intervention name: Vaginal tactile imager
description: Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after during a 3 month interval.
arm group label: Patients undergoing USI repair
criteria: 
gender: Female
gender based: Yes
gender description: Female.
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Roy Lauterbach, MD
role: Principal Investigator
affiliation: Rambam healthcare campus
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: ROY LAUTERBACH MD
investigator title: Principal Investigator
mesh term: Urinary Incontinence, Stress
sharing ipd: No