<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/NCT03801031</url>
  </required_header>
  <id_info>
    <org_study_id>201609770</org_study_id>
    <nct_id>NCT03801031</nct_id>
  </id_info>
  <brief_title>Sexual Dysfunction in Gynecologic Oncology Patients</brief_title>
  <official_title>Sexual Dysfunction in Gynecologic Oncology Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Bender</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      This project will evaluate sexual dysfunction in women who have had surgery for gynecologic&#xD;
      cancer. The subjects will complete a set of questionnaires about health, daily living, sexual&#xD;
      encounters, and pain before their surgery and three times following. Each subject will be&#xD;
      randomized to receive either lidocaine or a placebo that is applied vaginally immediately&#xD;
      prior to any sexual encounters for approximately 6 months while maintaining a journal of&#xD;
      sexual encounters and pain. The subjects and healthcare providers will be blinded to the&#xD;
      treatment randomization until intervention and data collection is complete. Total&#xD;
      participation will last up to one year from the date of enrollment. Subjects will visit the&#xD;
      clinic at the same time as regular cancer care visits, receive the blinded intervention and&#xD;
      complete the surveys.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once consented, subjects will complete nine short surveys (The Female Sexual Function Index,&#xD;
      The PHQ-9, the GAD-7, the Social Provision Score (SPS), Rosenberg's Body Self-Esteem Index,&#xD;
      the Severity of Posttraumatic Stress (PTS) Symptoms Scale, the Adverse Childhood Events&#xD;
      Index, the Short Form (SF)-12, and the Dyadic Adjustment Scale) at their initial visit,&#xD;
      assessing physical, psychological, and social elements related to sexuality.&#xD;
&#xD;
      Subjects will then have the tumor reduction surgery.&#xD;
&#xD;
      Twelve weeks after her surgery, each subject will be asked to complete the same nine-survey&#xD;
      packet.&#xD;
&#xD;
      Once the second packet is completed, subjects will be randomized to receive either aqueous&#xD;
      lidocaine (4%) or placebo with instructions to apply the solution to three cotton balls and&#xD;
      place them on the perineum/vaginal introitus for one minute prior to sexual intercourse.&#xD;
      Subjects will be educated on the use of this blinded intervention and be asked to keep a&#xD;
      diary of sexual encounters, including a simple pictorial pain scale for each encounter.&#xD;
      Subjects and providers are blinded to the assigned intervention.&#xD;
&#xD;
      Once subjects complete three months of perineal intervention, they will be asked at a&#xD;
      follow-up visit (12 weeks following randomization) to complete the survey packet for a third&#xD;
      time.&#xD;
&#xD;
      Subjects will then continue their perineal intervention, keep a diary of sexual encounters&#xD;
      with the pain scale and return after another three-month interval for a fourth completion of&#xD;
      the survey packet. Sexual encounter diaries and pain scale assessments will be collected and&#xD;
      their participation in the trial will conclude. Also at the time of this concluding follow-up&#xD;
      visit in the Gynecologic Oncology Clinic, patients will receive counseling by a gynecologic&#xD;
      oncologist regarding education about sexual dysfunction, the possibility of experiencing&#xD;
      sexual dysfunction, and a potential referral for further treatment of sexual dysfunction. The&#xD;
      subject will remain blinded to the randomized intervention until the conclusion of the study.&#xD;
&#xD;
      Subjects will be unblinded and informed of assigned intervention at the conclusion of the&#xD;
      study via a letter sent to their home address from the researchers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual&#xD;
  </why_stopped>
  <start_date type="Actual">June 6, 2019</start_date>
  <completion_date type="Actual">November 3, 2021</completion_date>
  <primary_completion_date type="Actual">November 3, 2021</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Sexual Function</measure>
    <time_frame>9 months</time_frame>
    <description>Sexual function measured by the Female Sexual Function Index (FSFI) survey, a 19-item self-report survey measuring sexual function. Item responses are on a 5-point scale and the total scores range 2 to 36 points, considering that the higher the score obtained, the better the sexual function of the woman.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Pain</measure>
    <time_frame>9 months</time_frame>
    <description>Pain is measured by using the visual analog scale for pain, which is a scale of 0-10, utilizing numbers and face illustrations to describe pain level. Pain level is measured on a 0-10 point scale, 0 indicating no pain and 10 indicating the worst pain possible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>9 months</time_frame>
    <description>Mean Change in Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report instrument to screen for depression. Responses range from 0-3 and the scores range from 0-27, the higher total score indicates more depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>9 months</time_frame>
    <description>Mean change in Generalized Anxiety Disorder 7-item scale (GAD-7), a brief self-report instrument of 7 items to assess generalized anxiety disorder. Responses range from 0-3 and the scores range from 0-21, the higher total score indicates more anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationships and Social Support</measure>
    <time_frame>9 months</time_frame>
    <description>Mean change in Social Provisions Scale, a 24-item self-reported survey measuring perceived social support to assess confounders on sexual function. Responses range from 1-4 and higher total scores indicate greater social connection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Esteem</measure>
    <time_frame>9 months</time_frame>
    <description>Mean change of Rosenberg's Body Self-Esteem Index, a 10-item self-report survey assessing global self-worth by measuring both positive and negative feelings about the self. Total scores range between 0 and 40; higher scores indicate better self-esteem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Posttraumatic Stress Symptoms</measure>
    <time_frame>9 months</time_frame>
    <description>Scores of Severity of Posttraumatic Stress Symptoms-Adult survey, a 9-item self-report instrument that assesses severity of posttraumatic stress disorder following a particular event or experience. Responses range from 0-4, 0 indicating no distress and 4 indicating extreme distress. Each item is measured on a 5-point scale (0=not at all; 4=extremely). Total score can range from 0-36 or averaged for 0-5. The higher scores indicate more severe PTS distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Childhood Events</measure>
    <time_frame>9 months</time_frame>
    <description>Presence, Severity, or Mean Change in Adverse Childhood Events Index, a 10-item self-report scale measuring types of physical, verbal, and emotional childhood trauma. Items are responded with yes or no. The total score is the sum of yes responses and range from 0-10. Higher total scores indicate more adverse childhood experiences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Status</measure>
    <time_frame>9 months</time_frame>
    <description>Mean Change in SF-12, a 12-item self-report measure of perceived general health status and disability. Responses include yes or no or ranges on 5- or 6-point scales. Higher total scores indicate more disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Romantic Relationships</measure>
    <time_frame>9 months</time_frame>
    <description>Mean Change in Dyadic Adjustment Scale (DAS), a 32-item self-report measure of couple satisfaction. Responses are 5- or 6-point scales or yes or no. Total scores range from 0 to 151. Higher total scores indicate higher adjustment and satisfaction in intimate relationships.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Gynecologic Cancer</condition>
  <condition>Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Topical</intervention_name>
    <description>Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
    <arm_group_label>Lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age 18-99&#xD;
&#xD;
          -  Planned to undergo primary surgical treatment at the University of Iowa Hospitals and&#xD;
             Clinics for a suspected or proven diagnosis of ovarian, fallopian tube, peritoneal,&#xD;
             endometrial, or cervical cancer&#xD;
&#xD;
          -  Able to give informed consent and follow study procedures&#xD;
&#xD;
          -  No previous reactions to lidocaine applications&#xD;
&#xD;
          -  Performance Status of 0 or 1&#xD;
&#xD;
          -  Reports having engaged in vaginal intercourse at least once in the last 12 months&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Failure to confirm invasive ovarian, fallopian tube, peritoneal, endometrial or&#xD;
             cervical cancer by pathology from primary biopsy or surgery (subjects will not be&#xD;
             eligible to continue the trial beyond the initial completion of the questionnaires)&#xD;
&#xD;
          -  Diagnosis of another malignancy within the past five years, excluding basal cell&#xD;
             carcinoma of the skin&#xD;
&#xD;
          -  Patients undergoing primary or adjuvant external pelvic radiation (excluding adjuvant&#xD;
             vaginal brachytherapy)&#xD;
&#xD;
          -  Previous reactions to lidocaine applications&#xD;
&#xD;
          -  Previous reactions to lidocaine for the subjects' sexual partner(s)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Bender, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Abbott-Anderson K, Kwekkeboom KL. A systematic review of sexual concerns reported by gynecological cancer survivors. Gynecol Oncol. 2012 Mar;124(3):477-89. doi: 10.1016/j.ygyno.2011.11.030. Epub 2011 Nov 28. Erratum In: Gynecol Oncol. 2012 Sep;126(3):501-8.</citation>
    <PMID>22134375</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>October 14, 2022</results_first_submitted>
  <results_first_submitted_qc>November 10, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 6, 2022</results_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>David Bender</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03801031/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03801031/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Subjects will complete nine short surveys at their initial visit, assessing physical, psychological, and social elements related to sexuality. Subjects will then have the tumor reduction surgery. Twelve weeks after surgery, each subject will be asked to complete the same nine-survey packet. Once the second packet is completed, subjects will be randomized to receive either the lidocaine solution or a placebo using permuted block technique based on cancer origin.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lidocaine</title>
          <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to comply</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lidocaine</title>
          <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56" lower_limit="41" upper_limit="68"/>
                    <measurement group_id="B2" value="52" lower_limit="52" upper_limit="52"/>
                    <measurement group_id="B3" value="55" lower_limit="41" upper_limit="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Sexual Function</title>
        <description>Sexual function measured by the Female Sexual Function Index (FSFI) survey, a 19-item self-report survey measuring sexual function. Item responses are on a 5-point scale and the total scores range 2 to 36 points, considering that the higher the score obtained, the better the sexual function of the woman.</description>
        <time_frame>9 months</time_frame>
        <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Sexual Function</title>
          <description>Sexual function measured by the Female Sexual Function Index (FSFI) survey, a 19-item self-report survey measuring sexual function. Item responses are on a 5-point scale and the total scores range 2 to 36 points, considering that the higher the score obtained, the better the sexual function of the woman.</description>
          <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Pain</title>
        <description>Pain is measured by using the visual analog scale for pain, which is a scale of 0-10, utilizing numbers and face illustrations to describe pain level. Pain level is measured on a 0-10 point scale, 0 indicating no pain and 10 indicating the worst pain possible.</description>
        <time_frame>9 months</time_frame>
        <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Pain</title>
          <description>Pain is measured by using the visual analog scale for pain, which is a scale of 0-10, utilizing numbers and face illustrations to describe pain level. Pain level is measured on a 0-10 point scale, 0 indicating no pain and 10 indicating the worst pain possible.</description>
          <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depressive Symptoms</title>
        <description>Mean Change in Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report instrument to screen for depression. Responses range from 0-3 and the scores range from 0-27, the higher total score indicates more depression.</description>
        <time_frame>9 months</time_frame>
        <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Depressive Symptoms</title>
          <description>Mean Change in Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report instrument to screen for depression. Responses range from 0-3 and the scores range from 0-27, the higher total score indicates more depression.</description>
          <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxiety</title>
        <description>Mean change in Generalized Anxiety Disorder 7-item scale (GAD-7), a brief self-report instrument of 7 items to assess generalized anxiety disorder. Responses range from 0-3 and the scores range from 0-21, the higher total score indicates more anxiety.</description>
        <time_frame>9 months</time_frame>
        <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety</title>
          <description>Mean change in Generalized Anxiety Disorder 7-item scale (GAD-7), a brief self-report instrument of 7 items to assess generalized anxiety disorder. Responses range from 0-3 and the scores range from 0-21, the higher total score indicates more anxiety.</description>
          <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relationships and Social Support</title>
        <description>Mean change in Social Provisions Scale, a 24-item self-reported survey measuring perceived social support to assess confounders on sexual function. Responses range from 1-4 and higher total scores indicate greater social connection.</description>
        <time_frame>9 months</time_frame>
        <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Relationships and Social Support</title>
          <description>Mean change in Social Provisions Scale, a 24-item self-reported survey measuring perceived social support to assess confounders on sexual function. Responses range from 1-4 and higher total scores indicate greater social connection.</description>
          <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-Esteem</title>
        <description>Mean change of Rosenberg's Body Self-Esteem Index, a 10-item self-report survey assessing global self-worth by measuring both positive and negative feelings about the self. Total scores range between 0 and 40; higher scores indicate better self-esteem.</description>
        <time_frame>9 months</time_frame>
        <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Esteem</title>
          <description>Mean change of Rosenberg's Body Self-Esteem Index, a 10-item self-report survey assessing global self-worth by measuring both positive and negative feelings about the self. Total scores range between 0 and 40; higher scores indicate better self-esteem.</description>
          <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Posttraumatic Stress Symptoms</title>
        <description>Scores of Severity of Posttraumatic Stress Symptoms-Adult survey, a 9-item self-report instrument that assesses severity of posttraumatic stress disorder following a particular event or experience. Responses range from 0-4, 0 indicating no distress and 4 indicating extreme distress. Each item is measured on a 5-point scale (0=not at all; 4=extremely). Total score can range from 0-36 or averaged for 0-5. The higher scores indicate more severe PTS distress.</description>
        <time_frame>9 months</time_frame>
        <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Posttraumatic Stress Symptoms</title>
          <description>Scores of Severity of Posttraumatic Stress Symptoms-Adult survey, a 9-item self-report instrument that assesses severity of posttraumatic stress disorder following a particular event or experience. Responses range from 0-4, 0 indicating no distress and 4 indicating extreme distress. Each item is measured on a 5-point scale (0=not at all; 4=extremely). Total score can range from 0-36 or averaged for 0-5. The higher scores indicate more severe PTS distress.</description>
          <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Childhood Events</title>
        <description>Presence, Severity, or Mean Change in Adverse Childhood Events Index, a 10-item self-report scale measuring types of physical, verbal, and emotional childhood trauma. Items are responded with yes or no. The total score is the sum of yes responses and range from 0-10. Higher total scores indicate more adverse childhood experiences.</description>
        <time_frame>9 months</time_frame>
        <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Childhood Events</title>
          <description>Presence, Severity, or Mean Change in Adverse Childhood Events Index, a 10-item self-report scale measuring types of physical, verbal, and emotional childhood trauma. Items are responded with yes or no. The total score is the sum of yes responses and range from 0-10. Higher total scores indicate more adverse childhood experiences.</description>
          <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Status</title>
        <description>Mean Change in SF-12, a 12-item self-report measure of perceived general health status and disability. Responses include yes or no or ranges on 5- or 6-point scales. Higher total scores indicate more disability.</description>
        <time_frame>9 months</time_frame>
        <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Status</title>
          <description>Mean Change in SF-12, a 12-item self-report measure of perceived general health status and disability. Responses include yes or no or ranges on 5- or 6-point scales. Higher total scores indicate more disability.</description>
          <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Romantic Relationships</title>
        <description>Mean Change in Dyadic Adjustment Scale (DAS), a 32-item self-report measure of couple satisfaction. Responses are 5- or 6-point scales or yes or no. Total scores range from 0 to 151. Higher total scores indicate higher adjustment and satisfaction in intimate relationships.</description>
        <time_frame>9 months</time_frame>
        <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Romantic Relationships</title>
          <description>Mean Change in Dyadic Adjustment Scale (DAS), a 32-item self-report measure of couple satisfaction. Responses are 5- or 6-point scales or yes or no. Total scores range from 0 to 151. Higher total scores indicate higher adjustment and satisfaction in intimate relationships.</description>
          <population>Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Study participants will be asked if there have been any reactions to the solution supplied for perineal application at each clinic visit, up 6 months post-surgical intervention.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lidocaine</title>
          <description>Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.&#xD;
Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.&#xD;
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study stopped accrual early due to unmet targeted accrual goals with 4 subjects accrued out of 120 planned.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>David Bender, MD</name_or_title>
      <organization>University of Iowa</organization>
      <phone>319-356-2015</phone>
      <email>david-bender@uiowa.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03801031
org study id: 201609770
nct id: NCT03801031
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This project will evaluate sexual dysfunction in women who have had surgery for gynecologic
      cancer. The subjects will complete a set of questionnaires about health, daily living, sexual
      encounters, and pain before their surgery and three times following. Each subject will be
      randomized to receive either lidocaine or a placebo that is applied vaginally immediately
      prior to any sexual encounters for approximately 6 months while maintaining a journal of
      sexual encounters and pain. The subjects and healthcare providers will be blinded to the
      treatment randomization until intervention and data collection is complete. Total
      participation will last up to one year from the date of enrollment. Subjects will visit the
      clinic at the same time as regular cancer care visits, receive the blinded intervention and
      complete the surveys.
Once consented, subjects will complete nine short surveys (The Female Sexual Function Index,
      The PHQ-9, the GAD-7, the Social Provision Score (SPS), Rosenberg's Body Self-Esteem Index,
      the Severity of Posttraumatic Stress (PTS) Symptoms Scale, the Adverse Childhood Events
      Index, the Short Form (SF)-12, and the Dyadic Adjustment Scale) at their initial visit,
      assessing physical, psychological, and social elements related to sexuality.

      Subjects will then have the tumor reduction surgery.

      Twelve weeks after her surgery, each subject will be asked to complete the same nine-survey
      packet.

      Once the second packet is completed, subjects will be randomized to receive either aqueous
      lidocaine (4%) or placebo with instructions to apply the solution to three cotton balls and
      place them on the perineum/vaginal introitus for one minute prior to sexual intercourse.
      Subjects will be educated on the use of this blinded intervention and be asked to keep a
      diary of sexual encounters, including a simple pictorial pain scale for each encounter.
      Subjects and providers are blinded to the assigned intervention.

      Once subjects complete three months of perineal intervention, they will be asked at a
      follow-up visit (12 weeks following randomization) to complete the survey packet for a third
      time.

      Subjects will then continue their perineal intervention, keep a diary of sexual encounters
      with the pain scale and return after another three-month interval for a fourth completion of
      the survey packet. Sexual encounter diaries and pain scale assessments will be collected and
      their participation in the trial will conclude. Also at the time of this concluding follow-up
      visit in the Gynecologic Oncology Clinic, patients will receive counseling by a gynecologic
      oncologist regarding education about sexual dysfunction, the possibility of experiencing
      sexual dysfunction, and a potential referral for further treatment of sexual dysfunction. The
      subject will remain blinded to the randomized intervention until the conclusion of the study.

      Subjects will be unblinded and informed of assigned intervention at the conclusion of the
      study via a letter sent to their home address from the researchers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Changes in Sexual Function
time frame: 9 months
description: Sexual function measured by the Female Sexual Function Index (FSFI) survey, a 19-item self-report survey measuring sexual function. Item responses are on a 5-point scale and the total scores range 2 to 36 points, considering that the higher the score obtained, the better the sexual function of the woman.
measure: Changes in Pain
time frame: 9 months
description: Pain is measured by using the visual analog scale for pain, which is a scale of 0-10, utilizing numbers and face illustrations to describe pain level. Pain level is measured on a 0-10 point scale, 0 indicating no pain and 10 indicating the worst pain possible.
measure: Depressive Symptoms
time frame: 9 months
description: Mean Change in Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report instrument to screen for depression. Responses range from 0-3 and the scores range from 0-27, the higher total score indicates more depression.
measure: Anxiety
time frame: 9 months
description: Mean change in Generalized Anxiety Disorder 7-item scale (GAD-7), a brief self-report instrument of 7 items to assess generalized anxiety disorder. Responses range from 0-3 and the scores range from 0-21, the higher total score indicates more anxiety.
measure: Relationships and Social Support
time frame: 9 months
description: Mean change in Social Provisions Scale, a 24-item self-reported survey measuring perceived social support to assess confounders on sexual function. Responses range from 1-4 and higher total scores indicate greater social connection.
measure: Self-Esteem
time frame: 9 months
description: Mean change of Rosenberg's Body Self-Esteem Index, a 10-item self-report survey assessing global self-worth by measuring both positive and negative feelings about the self. Total scores range between 0 and 40; higher scores indicate better self-esteem.
measure: Posttraumatic Stress Symptoms
time frame: 9 months
description: Scores of Severity of Posttraumatic Stress Symptoms-Adult survey, a 9-item self-report instrument that assesses severity of posttraumatic stress disorder following a particular event or experience. Responses range from 0-4, 0 indicating no distress and 4 indicating extreme distress. Each item is measured on a 5-point scale (0=not at all; 4=extremely). Total score can range from 0-36 or averaged for 0-5. The higher scores indicate more severe PTS distress.
measure: Adverse Childhood Events
time frame: 9 months
description: Presence, Severity, or Mean Change in Adverse Childhood Events Index, a 10-item self-report scale measuring types of physical, verbal, and emotional childhood trauma. Items are responded with yes or no. The total score is the sum of yes responses and range from 0-10. Higher total scores indicate more adverse childhood experiences.
measure: Health Status
time frame: 9 months
description: Mean Change in SF-12, a 12-item self-report measure of perceived general health status and disability. Responses include yes or no or ranges on 5- or 6-point scales. Higher total scores indicate more disability.
measure: Romantic Relationships
time frame: 9 months
description: Mean Change in Dyadic Adjustment Scale (DAS), a 32-item self-report measure of couple satisfaction. Responses are 5- or 6-point scales or yes or no. Total scores range from 0 to 151. Higher total scores indicate higher adjustment and satisfaction in intimate relationships.
arm group label: Lidocaine
arm group type: Active Comparator
description: Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.
intervention type: Drug
intervention name: Lidocaine Topical
description: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.
arm group label: Lidocaine
intervention type: Drug
intervention name: Placebo
description: Placebo solution intervention used to validate the effects of the lidocaine solution usage.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: David Bender, MD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
citation: Abbott-Anderson K, Kwekkeboom KL. A systematic review of sexual concerns reported by gynecological cancer survivors. Gynecol Oncol. 2012 Mar;124(3):477-89. doi: 10.1016/j.ygyno.2011.11.030. Epub 2011 Nov 28. Erratum In: Gynecol Oncol. 2012 Sep;126(3):501-8.
PMID: 22134375
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: David Bender
investigator title: Principal Investigator
mesh term: Lidocaine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study stopped accrual early due to unmet targeted accrual goals with 4 subjects accrued out of 120 planned.
point of contact: 