<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/NCT02261974</url>
  </required_header>
  <id_info>
    <org_study_id>(OUS) V-013</org_study_id>
    <nct_id>NCT02261974</nct_id>
  </id_info>
  <brief_title>VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness</brief_title>
  <acronym>VIVEVE I</acronym>
  <official_title>VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Viveve Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Viveve Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design&#xD;
&#xD;
      The objective of this study is to determine the safety and effectiveness of the Viveve System&#xD;
      to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving&#xD;
      vaginal laxity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, longitudinal, randomized, single-blind, sham controlled clinical study is&#xD;
      planned. This study is designed to demonstrate that the active treatment (i.e., Viveve&#xD;
      Procedure) is superior to the sham treatment for the primary effectiveness and safety&#xD;
      endpoints.&#xD;
&#xD;
      Approximately 113 evaluable subjects will be randomized in a 2:1 ratio to either the active&#xD;
      treatment group or sham group. The active treatment group will receive a treatment dose of 90&#xD;
      J/cm2 and the sham group will receive a sub-treatment dose of ≤1 J/cm2.&#xD;
&#xD;
      Subjects will be followed up at 72 hrs, 10 days, and one, two, three, and six months post&#xD;
      treatment.&#xD;
&#xD;
      Final data will be reported at 6 months for active and sham treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score</measure>
    <time_frame>6 months</time_frame>
    <description>The mean change from baseline in FSFI total score in the active arm compared to the sham arm. The FSFI is a 19-item validated measure of female sexual function. It consists of 6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor (factors are permanent and do not change). The 6 domain scores are then summed to obtain the FSFI total score. The total score ranges from 2-36. A higher score indicates a greater level of sexual function, while a lower score correlates to a greater level of sexual dysfunction. Within individual domains, a domain score of 0 indicates that the subject reported having no sexual activity during the past month. The baseline score is the FSFI total score from the screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reporting Adverse Events (AEs)</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score</measure>
    <time_frame>6 months</time_frame>
    <description>Vaginal Introitus Laxity Inventory (VALI) is a 12-item patient reported outcome measure designed to describe and quantify the nature of a female respondent's concern with the perception of laxity (&quot;looseness&quot;) and its impact on the qualities of satisfaction and enjoyment of her sexual functioning. Items of the VALI address the impact of laxity on the major aspects of the female sexual response cycle (i.e., sexual desire, arousal and orgasm), and quantify the patient's experience of sexual pleasure, sensitivity and satisfaction. The VALI items also address the potential impact of vaginal introitus laxity on sexual confidence and the patient's partner. All 12 items are measured on 5-point Likert scales (0= Very Poor, 1=Poor, 2=Moderate, 3=Good, 4=Very Good) and scores are summed to achieve a VALI Total score, range 0-48. A higher score corresponds to positive sexual satisfactions and functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)</measure>
    <time_frame>6 months</time_frame>
    <description>Mean change in VSQ Vaginal Laxity Question (VLQ) score from baseline to 6 months post-intervention. The VLQ is one question. The global assessment of vaginal laxity is scored on a seven-point Likert type scale where the response to the question ranges from 1-7 where 1 = &quot;Very Loose&quot; and 7 = &quot;Very Tight&quot;. The Likert-scale is one of the most widely used bipolar scaling method instruments in survey research. The VSQ VLQs levels of vaginal laxity uses a balanced keying (an equal number of positive and negative statements) to obviate the problem of acquisition bias. Baseline VLQ is the score indicated that the screening visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)</measure>
    <time_frame>6 months</time_frame>
    <description>The mean change in total FSDS-R score from baseline to six months post-intervention in the active arm compared to the sham arm. The FSDS-R is a 12-item patient-reported questionnaire and a validated scale used to measure sexually-related personal distress in women. Women rate 13 questions as Never (0), Rarely (1), Occasionally (2), Frequently (3), and Always (4), for a total score range of 0-52 (the individual question scores are summed to give the total score). A higher frequency of occurrences (which correlates to a total higher score) indicates a greater distress or a &quot;worse outcome&quot;. The numbers below represent the changes from baseline in mean FSDS-R total score. The baseline value is the FSDS-R total score at screening.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Vaginal Laxity Following Childbirth</condition>
  <condition>Sexual Function Following Childbirth</condition>
  <arm_group>
    <arm_group_label>Active Viveve Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Viveve Treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Treatment Viveve</intervention_name>
    <description>Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus</description>
    <arm_group_label>Active Viveve Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Treatment Viveve</intervention_name>
    <description>Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus</description>
    <arm_group_label>Sham Viveve Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Able to understand and voluntarily sign the informed consent form&#xD;
&#xD;
          2. Pre-menopausal and ≥ 18 years of age&#xD;
&#xD;
          3. At least one full term vaginal delivery (&gt; 37 completed weeks gestation) at least 12&#xD;
             months prior to enrollment date&#xD;
&#xD;
          4. Experiences vaginal looseness (laxity) during vaginal intercourse&#xD;
&#xD;
          5. Subject must have a screening blood count and metabolic panel including FSH level of&#xD;
             &lt;35 mIU/mL (35 IU/L).&#xD;
&#xD;
          6. Subject must have a normal pelvic exam at baseline and negative chlamydia and&#xD;
             gonorrhea cultures during the screening period.&#xD;
&#xD;
          7. Subject had a normal PAP within last three years, cytology, no HPV and within last&#xD;
             five years, cytology and no HPV.&#xD;
&#xD;
          8. Subject must be willing to engage in vaginal intercourse at least once per month.&#xD;
&#xD;
          9. Subject must be in a monogamous, heterosexual relationship for at least six months&#xD;
             prior to screening visit with a partner who is sexually functional and available at&#xD;
             least 50% of the time.&#xD;
&#xD;
         10. Subject is surgically sterilized, or is willing to use an acceptable method of birth&#xD;
             control that was begun at least 3 month prior to screening and to be continued or&#xD;
             throughout the duration of the study [i.e., barrier method (e.g., diaphragm), hormonal&#xD;
             therapy (subcutaneous, injectable, or oral contraceptive) intrauterine device], or&#xD;
             partner is surgically sterilized&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or planning to become pregnant within the next 12 months or has had a&#xD;
             delivery within the last 12 months.&#xD;
&#xD;
          2. Currently breastfeeding or discontinued breast feeding fewer than 6 months prior to&#xD;
             enrollment&#xD;
&#xD;
          3. History of a genital fistula, a thin recto-vaginal septum as determined by the&#xD;
             investigator, or history of a fourth degree laceration during screening physical exam&#xD;
&#xD;
          4. Clinically significant pelvic organ prolapse&#xD;
&#xD;
          5. Currently meets the criteria for a female sexual disorder, including DSM V, FSAD, FOD,&#xD;
             Genitopelvic Pain, Sexual Aversion, Dyspareunia, or Vaginismus, and has not been&#xD;
             treated for this condition within the past 12 months&#xD;
&#xD;
          6. Beck Depression Inventory score &gt; 14&#xD;
&#xD;
          7. DSM-5 psychiatric diagnosis exhibiting clinically significant symptoms&#xD;
&#xD;
          8. Taking SSNRI or SSRI drugs&#xD;
&#xD;
          9. Not willing to abstain from vaginal intercourse or use of tampons until 10-day&#xD;
             follow-up visit completed&#xD;
&#xD;
         10. Evidence of active sexually transmitted disease upon vaginal exam that precludes&#xD;
             treatment&#xD;
&#xD;
         11. History of genital herpes&#xD;
&#xD;
         12. Clinically significant abnormalities in clinical chemistry or hematology at the time&#xD;
             of screening&#xD;
&#xD;
         13. Currently taking prescribed medications, OTC products or supplements that may impact&#xD;
             or enhance sexual function (e.g., antihypertensive, psychotropic, chemotherapeutic&#xD;
             agent, PD5 Inhibitors) as assessed by the investigator&#xD;
&#xD;
         14. Currently undergoing chemotherapy, radiation therapy, or pelvic floor physical therapy&#xD;
&#xD;
         15. Has an implantable pacemaker, an automatic implantable cardioverter/defibrillator&#xD;
             (AICD), or any other implantable electrical device, as these devices may be adversely&#xD;
             affected by radiofrequency fields or current&#xD;
&#xD;
         16. Has undergone the Viveve Procedure previously&#xD;
&#xD;
         17. Has medical condition that in investigator's opinion may interfere with wound healing&#xD;
             response&#xD;
&#xD;
         18. Has an acute or a chronic vaginal or vulvar disorder (e.g., vaginal atrophy, pain&#xD;
             including vulvodynia, vulvar vestibulitis dysethetic vulvodynia or vulvar dystrophy,&#xD;
             current/chronic papulosquamous vulvar dermatoses (e.g., psoriasis lichen planus, tinea&#xD;
             cruris, lichen sclerosis, seborrhea dermatitis, contact or irritant dermatitis, lichen&#xD;
             simplex, eczema) or bullous dermatoses or systemic diseases with potential involvement&#xD;
             of vulva)&#xD;
&#xD;
         19. Has Irritable Bowel Syndrome or Crohn's Disease&#xD;
&#xD;
         20. Has dyspareunia defined as recurrent or persistent painful intercourse that affects&#xD;
             sexual activity&#xD;
&#xD;
         21. Has been in another clinical study within four weeks of screening, or is not willing&#xD;
             to abstain from enrolling in other clinical studies for duration of trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Debbie Wilkerson, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Viveve Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Allan Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>AB T2 7G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complexe Medical St-Laurent</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4R 0B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Les Cours Medical Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>QC H3 A1 T5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exogenia Institute of Anti-Aging and Regenerative Medicine</name>
      <address>
        <city>Sherbrooke</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center of Reproductive Medicine. - IRCCS Policlinico San Matteo Hospital</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama Motomachi Jyosei Iryou Clinic Luna</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naoe Beauty Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Palacios, Salud de la Mujer</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Gestión Clínica de Obstetricia y Ginecología. Hospital Universitario Araba</name>
      <address>
        <city>Vitoria</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <results_first_submitted>March 27, 2017</results_first_submitted>
  <results_first_submitted_qc>December 1, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 27, 2017</results_first_posted>
  <last_update_submitted>July 30, 2018</last_update_submitted>
  <last_update_submitted_qc>July 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vaginal laxity</keyword>
  <keyword>Sexual Function</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active Viveve Treatment</title>
          <description>Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus&#xD;
Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus</description>
        </group>
        <group group_id="P2">
          <title>Sham Viveve Treatment</title>
          <description>Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus&#xD;
Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed treatment cut-off date</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Received partial treatment; FU to 1 mo</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Viveve Treatment</title>
          <description>Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus&#xD;
Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus</description>
        </group>
        <group group_id="B2">
          <title>Sham Viveve Treatment</title>
          <description>Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus&#xD;
Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus</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="123"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="186"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.6" spread="6.0"/>
                    <measurement group_id="B2" value="41.1" spread="5.6"/>
                    <measurement group_id="B3" value="40.8" spread="5.9"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="186"/>
                  </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 and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.6" spread="4.6"/>
                    <measurement group_id="B2" value="24.4" spread="5.4"/>
                    <measurement group_id="B3" value="24.5" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hypertension</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear, nose, or throat condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dermatologic condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulmonary condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatic or biliary condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endocrine condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurologic condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychiatric condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematologic condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Allergies</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gynecologic condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior Surgeries</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior STD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gravidity Per Subject</title>
          <description>Average number of reported pregnancies per subject</description>
          <units>Pregnancies</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.7" spread="1.4"/>
                    <measurement group_id="B2" value="2.7" spread="1.3"/>
                    <measurement group_id="B3" value="2.7" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time Since Last Delivery</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.0" spread="6.3"/>
                    <measurement group_id="B2" value="8" spread="5.5"/>
                    <measurement group_id="B3" value="8" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Median Birth weight</title>
          <description>Maternal History: Average of median birth weights.</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.3" spread=".7"/>
                    <measurement group_id="B2" value="3.4" spread=".5"/>
                    <measurement group_id="B3" value="3.3" spread=".6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Vaginal Deliveries per Subject</title>
          <units>Number of Reported Vaginal Deliveries</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.1" spread="1"/>
                    <measurement group_id="B2" value="2" spread=".9"/>
                    <measurement group_id="B3" value="2.1" spread=".9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score</title>
        <description>The mean change from baseline in FSFI total score in the active arm compared to the sham arm. The FSFI is a 19-item validated measure of female sexual function. It consists of 6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor (factors are permanent and do not change). The 6 domain scores are then summed to obtain the FSFI total score. The total score ranges from 2-36. A higher score indicates a greater level of sexual function, while a lower score correlates to a greater level of sexual dysfunction. Within individual domains, a domain score of 0 indicates that the subject reported having no sexual activity during the past month. The baseline score is the FSFI total score from the screening visit.</description>
        <time_frame>6 months</time_frame>
        <population>This population consists of all randomized subjects who completed the six month assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Viveve Treatment</title>
            <description>Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus&#xD;
Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus</description>
          </group>
          <group group_id="O2">
            <title>Sham Viveve Treatment</title>
            <description>Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus&#xD;
Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score</title>
          <description>The mean change from baseline in FSFI total score in the active arm compared to the sham arm. The FSFI is a 19-item validated measure of female sexual function. It consists of 6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor (factors are permanent and do not change). The 6 domain scores are then summed to obtain the FSFI total score. The total score ranges from 2-36. A higher score indicates a greater level of sexual function, while a lower score correlates to a greater level of sexual dysfunction. Within individual domains, a domain score of 0 indicates that the subject reported having no sexual activity during the past month. The baseline score is the FSFI total score from the screening visit.</description>
          <population>This population consists of all randomized subjects who completed the six month assessment.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.16" spread="0.48"/>
                    <measurement group_id="O2" value="2.36" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Reporting Adverse Events (AEs)</title>
        <description>Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.</description>
        <time_frame>6 months</time_frame>
        <population>Table includes treatment-emergent adverse events (AEs), defined as AEs that began or worsened in severity after treatment.&#xD;
This population consists of all subjects who were randomized and who received a complete or partial treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Viveve Treatment</title>
            <description>Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus&#xD;
Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus</description>
          </group>
          <group group_id="O2">
            <title>Sham Viveve Treatment</title>
            <description>Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus&#xD;
Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus</description>
          </group>
        </group_list>
        <measure>
          <title>Reporting Adverse Events (AEs)</title>
          <description>Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.</description>
          <population>Table includes treatment-emergent adverse events (AEs), defined as AEs that began or worsened in severity after treatment.&#xD;
This population consists of all subjects who were randomized and who received a complete or partial treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score</title>
        <description>Vaginal Introitus Laxity Inventory (VALI) is a 12-item patient reported outcome measure designed to describe and quantify the nature of a female respondent's concern with the perception of laxity (&quot;looseness&quot;) and its impact on the qualities of satisfaction and enjoyment of her sexual functioning. Items of the VALI address the impact of laxity on the major aspects of the female sexual response cycle (i.e., sexual desire, arousal and orgasm), and quantify the patient's experience of sexual pleasure, sensitivity and satisfaction. The VALI items also address the potential impact of vaginal introitus laxity on sexual confidence and the patient's partner. All 12 items are measured on 5-point Likert scales (0= Very Poor, 1=Poor, 2=Moderate, 3=Good, 4=Very Good) and scores are summed to achieve a VALI Total score, range 0-48. A higher score corresponds to positive sexual satisfactions and functioning.</description>
        <time_frame>6 months</time_frame>
        <population>This population consists of all randomized subjects with a 6 month assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Viveve Treatment</title>
            <description>Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus&#xD;
Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus</description>
          </group>
          <group group_id="O2">
            <title>Sham Viveve Treatment</title>
            <description>Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus&#xD;
Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score</title>
          <description>Vaginal Introitus Laxity Inventory (VALI) is a 12-item patient reported outcome measure designed to describe and quantify the nature of a female respondent's concern with the perception of laxity (&quot;looseness&quot;) and its impact on the qualities of satisfaction and enjoyment of her sexual functioning. Items of the VALI address the impact of laxity on the major aspects of the female sexual response cycle (i.e., sexual desire, arousal and orgasm), and quantify the patient's experience of sexual pleasure, sensitivity and satisfaction. The VALI items also address the potential impact of vaginal introitus laxity on sexual confidence and the patient's partner. All 12 items are measured on 5-point Likert scales (0= Very Poor, 1=Poor, 2=Moderate, 3=Good, 4=Very Good) and scores are summed to achieve a VALI Total score, range 0-48. A higher score corresponds to positive sexual satisfactions and functioning.</description>
          <population>This population consists of all randomized subjects with a 6 month assessment.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.28" spread="0.64"/>
                    <measurement group_id="O2" value="6.32" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)</title>
        <description>Mean change in VSQ Vaginal Laxity Question (VLQ) score from baseline to 6 months post-intervention. The VLQ is one question. The global assessment of vaginal laxity is scored on a seven-point Likert type scale where the response to the question ranges from 1-7 where 1 = &quot;Very Loose&quot; and 7 = &quot;Very Tight&quot;. The Likert-scale is one of the most widely used bipolar scaling method instruments in survey research. The VSQ VLQs levels of vaginal laxity uses a balanced keying (an equal number of positive and negative statements) to obviate the problem of acquisition bias. Baseline VLQ is the score indicated that the screening visit.</description>
        <time_frame>6 months</time_frame>
        <population>This population consists of all randomized subjects who completed a 6 month assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Viveve Treatment</title>
            <description>Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus&#xD;
Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus</description>
          </group>
          <group group_id="O2">
            <title>Sham Viveve Treatment</title>
            <description>Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus&#xD;
Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)</title>
          <description>Mean change in VSQ Vaginal Laxity Question (VLQ) score from baseline to 6 months post-intervention. The VLQ is one question. The global assessment of vaginal laxity is scored on a seven-point Likert type scale where the response to the question ranges from 1-7 where 1 = &quot;Very Loose&quot; and 7 = &quot;Very Tight&quot;. The Likert-scale is one of the most widely used bipolar scaling method instruments in survey research. The VSQ VLQs levels of vaginal laxity uses a balanced keying (an equal number of positive and negative statements) to obviate the problem of acquisition bias. Baseline VLQ is the score indicated that the screening visit.</description>
          <population>This population consists of all randomized subjects who completed a 6 month assessment.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.81" spread="0.15"/>
                    <measurement group_id="O2" value="1.07" spread=".21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)</title>
        <description>The mean change in total FSDS-R score from baseline to six months post-intervention in the active arm compared to the sham arm. The FSDS-R is a 12-item patient-reported questionnaire and a validated scale used to measure sexually-related personal distress in women. Women rate 13 questions as Never (0), Rarely (1), Occasionally (2), Frequently (3), and Always (4), for a total score range of 0-52 (the individual question scores are summed to give the total score). A higher frequency of occurrences (which correlates to a total higher score) indicates a greater distress or a &quot;worse outcome&quot;. The numbers below represent the changes from baseline in mean FSDS-R total score. The baseline value is the FSDS-R total score at screening.</description>
        <time_frame>6 months</time_frame>
        <population>This population consists of all randomized subjects who completed a 6 month assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Viveve Treatment</title>
            <description>Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus&#xD;
Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus</description>
          </group>
          <group group_id="O2">
            <title>Sham Viveve Treatment</title>
            <description>Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus&#xD;
Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)</title>
          <description>The mean change in total FSDS-R score from baseline to six months post-intervention in the active arm compared to the sham arm. The FSDS-R is a 12-item patient-reported questionnaire and a validated scale used to measure sexually-related personal distress in women. Women rate 13 questions as Never (0), Rarely (1), Occasionally (2), Frequently (3), and Always (4), for a total score range of 0-52 (the individual question scores are summed to give the total score). A higher frequency of occurrences (which correlates to a total higher score) indicates a greater distress or a &quot;worse outcome&quot;. The numbers below represent the changes from baseline in mean FSDS-R total score. The baseline value is the FSDS-R total score at screening.</description>
          <population>This population consists of all randomized subjects who completed a 6 month assessment.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.55" spread="0.74"/>
                    <measurement group_id="O2" value="-4.13" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months post-treatment</time_frame>
      <desc>The definitions of adverse event (AE) and serious adverse event (SAE) used in this study were consistent with the clinicaltrials.gov definitions. Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE), Version 4.3, which stratifies severity across five (5) levels rather than the three (3) used in the clinicaltrials.gov definitions.</desc>
      <group_list>
        <group group_id="E1">
          <title>Active Viveve Treatment</title>
          <description>Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus&#xD;
Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus</description>
        </group>
        <group group_id="E2">
          <title>Sham Viveve Treatment</title>
          <description>Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus&#xD;
Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1, English</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Kidney Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 18.1, English</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial Vaginosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Candida Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Chlamydial Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Endometritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Genital Herpes Simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Mycoplasma Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Trichomoniasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vaginal Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Mycotic Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vulvovaginitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Sports Injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Helicobacter Test Positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Facial Neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Coital Bleeding</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Dyspareunia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Hypomenorrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Inadequate Lubrication</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Premenstrual Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Pruritus Genital</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Ovarian Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Uterine Spasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vaginal Discharge</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="117"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vulval Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Burning Sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Dryness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
              </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>
    <point_of_contact>
      <name_or_title>Debbie Wilkerson, PhD, Vice President, Clinical and Medical Affairs</name_or_title>
      <organization>Viveve, Inc.</organization>
      <phone>610-209-9980</phone>
      <email>dwilkerson@viveve.com</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/NCT02261974
org study id: (OUS) V-013
nct id: NCT02261974
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design

      The objective of this study is to determine the safety and effectiveness of the Viveve System
      to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving
      vaginal laxity.
A prospective, longitudinal, randomized, single-blind, sham controlled clinical study is
      planned. This study is designed to demonstrate that the active treatment (i.e., Viveve
      Procedure) is superior to the sham treatment for the primary effectiveness and safety
      endpoints.

      Approximately 113 evaluable subjects will be randomized in a 2:1 ratio to either the active
      treatment group or sham group. The active treatment group will receive a treatment dose of 90
      J/cm2 and the sham group will receive a sub-treatment dose of ≤1 J/cm2.

      Subjects will be followed up at 72 hrs, 10 days, and one, two, three, and six months post
      treatment.

      Final data will be reported at 6 months for active and sham treatments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score
time frame: 6 months
description: The mean change from baseline in FSFI total score in the active arm compared to the sham arm. The FSFI is a 19-item validated measure of female sexual function. It consists of 6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor (factors are permanent and do not change). The 6 domain scores are then summed to obtain the FSFI total score. The total score ranges from 2-36. A higher score indicates a greater level of sexual function, while a lower score correlates to a greater level of sexual dysfunction. Within individual domains, a domain score of 0 indicates that the subject reported having no sexual activity during the past month. The baseline score is the FSFI total score from the screening visit.
measure: Reporting Adverse Events (AEs)
time frame: 6 months
description: Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.
measure: Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score
time frame: 6 months
description: Vaginal Introitus Laxity Inventory (VALI) is a 12-item patient reported outcome measure designed to describe and quantify the nature of a female respondent's concern with the perception of laxity ("looseness") and its impact on the qualities of satisfaction and enjoyment of her sexual functioning. Items of the VALI address the impact of laxity on the major aspects of the female sexual response cycle (i.e., sexual desire, arousal and orgasm), and quantify the patient's experience of sexual pleasure, sensitivity and satisfaction. The VALI items also address the potential impact of vaginal introitus laxity on sexual confidence and the patient's partner. All 12 items are measured on 5-point Likert scales (0= Very Poor, 1=Poor, 2=Moderate, 3=Good, 4=Very Good) and scores are summed to achieve a VALI Total score, range 0-48. A higher score corresponds to positive sexual satisfactions and functioning.
measure: Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)
time frame: 6 months
description: Mean change in VSQ Vaginal Laxity Question (VLQ) score from baseline to 6 months post-intervention. The VLQ is one question. The global assessment of vaginal laxity is scored on a seven-point Likert type scale where the response to the question ranges from 1-7 where 1 = "Very Loose" and 7 = "Very Tight". The Likert-scale is one of the most widely used bipolar scaling method instruments in survey research. The VSQ VLQs levels of vaginal laxity uses a balanced keying (an equal number of positive and negative statements) to obviate the problem of acquisition bias. Baseline VLQ is the score indicated that the screening visit.
measure: Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)
time frame: 6 months
description: The mean change in total FSDS-R score from baseline to six months post-intervention in the active arm compared to the sham arm. The FSDS-R is a 12-item patient-reported questionnaire and a validated scale used to measure sexually-related personal distress in women. Women rate 13 questions as Never (0), Rarely (1), Occasionally (2), Frequently (3), and Always (4), for a total score range of 0-52 (the individual question scores are summed to give the total score). A higher frequency of occurrences (which correlates to a total higher score) indicates a greater distress or a "worse outcome". The numbers below represent the changes from baseline in mean FSDS-R total score. The baseline value is the FSDS-R total score at screening.
arm group label: Active Viveve Treatment
arm group type: Active Comparator
description: Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus
arm group label: Sham Viveve Treatment
arm group type: Placebo Comparator
description: Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus
intervention type: Device
intervention name: Active Treatment Viveve
description: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus
arm group label: Active Viveve Treatment
intervention type: Device
intervention name: Sham Treatment Viveve
description: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
arm group label: Sham Viveve Treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Debbie Wilkerson, PhD
role: Study Director
affiliation: Viveve Inc.
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country: Canada
country: Italy
country: Japan
country: Spain
responsible party type: Sponsor
sharing ipd: No
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 