<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/NCT03010800</url>
  </required_header>
  <id_info>
    <org_study_id>WCP001</org_study_id>
    <nct_id>NCT03010800</nct_id>
  </id_info>
  <brief_title>A Feasibility Device Study to Prevent Female Urinary Stress Incontinence</brief_title>
  <official_title>Randomized, Crossover Feasibility Study of a Device to Prevent Female Urinary Stress Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Watkins Conti Products. Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Watkins Conti Products. Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test the acute efficacy of an investigational device (Yoni.Fit) in a clinical&#xD;
      trial of women with incontinence in a standardized set of challenges performed with and&#xD;
      without the device in place.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Potential subjects will be pre-qualified by a 6-item questionnaire, the validated&#xD;
           Questionnaire for Urinary Incontinence Diagnosis (QUID). This questionnaire has 3&#xD;
           questions each referring to the seriousness of Stress Urinary Incontinence (SUI) and of&#xD;
           Urge Urinary Incontinence (UUI). Subjects will be accepted if their SUI score is 5 or&#xD;
           greater and is greater than the UUI score. For privacy reasons, these scores will not be&#xD;
           retained. Subjects will then be given an appointment. Subjects will be instructed to&#xD;
           wear comfortable athletic type wear and not to drink any fluid for two hours prior to&#xD;
           their appointment.&#xD;
&#xD;
        2. When subjects appear for their appointment, subjects will be administered the informed&#xD;
           consent by the Study Coordinator. All paperwork will be pre-numbered with a code that&#xD;
           will link to the subject name. The key will be kept confidential by the Study&#xD;
           Coordinator. They will be instructed to empty their bladders and will be given a liter&#xD;
           of water or other drink and instructed to drink it over a 15-20 minute time period. An&#xD;
           abbreviated patient history will be obtained for the purpose of establishing whether the&#xD;
           subject meets the inclusion criteria and is not disqualified by meeting the exclusion&#xD;
           criteria. The subject will again fill out the QUID questionnaire. The inclusion criteria&#xD;
           are a SUI score of 5 or greater, predominately SUI (SUI score&gt;UUI score) and age between&#xD;
           25 and 65. Exclusion criteria are predominantly UUI, prolapse greater than mild,&#xD;
           hysterectomy or other pelvic floor surgery other than a Caesarian section, diabetes,&#xD;
           pregnant, BMI&gt;35 or unable to perform ten &quot;jumping jack&quot; exercises. Patients will be&#xD;
           administered three additional questionnaires in order to compute a Severity Score. These&#xD;
           questionnaires are the Urinary Distress Inventory (UDI), Urinary Impact Questionnaire&#xD;
           (UIQ) and the Incontinence Severity Index (ISI). The scores will be multiplied together&#xD;
           to provide the Severity Score.&#xD;
&#xD;
        3. Patients will be randomized to Group A or Group B to participate in an abbreviated Pad&#xD;
           Test. Group A will perform the test with the Yoni.Fit device in place then repeat the&#xD;
           test without the device. Group B will perform the test without the Yoni.Fit device in&#xD;
           place then repeat the test with the device in place. This test has been validated (5).&#xD;
           An hour after finishing the liter of liquid, the subject is given a tared incontinence&#xD;
           pad, which is then put in place. She then engages in the following mild exercise&#xD;
           challenges..&#xD;
&#xD;
             1. Stand from sitting 10 times.&#xD;
&#xD;
             2. Cough vigorously while standing.&#xD;
&#xD;
             3. Bend down to pick up small object.&#xD;
&#xD;
             4. Perform ten jumping jacks. The subject then will remove pad, place into bag and&#xD;
                seal. The Experimenter will then weigh pad. The subjects will be randomized so that&#xD;
                half will perform the Abbreviated Pad Test with the Yoni.Fit device in place&#xD;
                followed by repeating without the device in place. The other half will perform the&#xD;
                challenges in the reverse order.&#xD;
&#xD;
        4. The experimenter will calculate a change in score, which is the weight of the pad worn&#xD;
           without the device in place minus the tare weight of the pad divided by the weight of&#xD;
           the pad with the device in place minus the tare weight of the pad. In case no urine is&#xD;
           released with the device in place, the Improvement Score will be defined as &quot;1000&quot;. A&#xD;
           Release Change will also be calculated as the net weight without the device in place&#xD;
           minus the weight with the device in place divided by the net weight released without the&#xD;
           device in place.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Actual">May 3, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pad Weight Difference</measure>
    <time_frame>An hour after finishing a liter of liquid</time_frame>
    <description>Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Stress Incontinence, Female</condition>
  <arm_group>
    <arm_group_label>With Yoni.Fit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will perform the Abbreviated Pad Test with the Yoni.Fit first, then without the Yoni.Fit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without Yoni.Fit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will perform the Abbreviated Pad Test without the Yoni.Fit first, then with the Yoni.Fit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>With Yoni.Fit</intervention_name>
    <description>Abbreviated Pad Test with Yoni.Fit first, then without Yoni.Fit.</description>
    <arm_group_label>With Yoni.Fit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Without Yoni.Fit</intervention_name>
    <description>Abbreviated Pad Test without Yoni.Fit, then with Yoni.Fit.</description>
    <arm_group_label>Without Yoni.Fit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Urinary Incontinence Diagnosis (QUID). This questionnaire has 3 questions each&#xD;
             referring to the seriousness of Stress Urinary Incontinence (SUI) and of Urge Urinary&#xD;
             Incontinence (UUI). Subjects will be accepted if their SUI score is 5 or greater and&#xD;
             is greater than the UUI score.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to sign the informed consent document&#xD;
&#xD;
          -  SUI score is less than 5 or is less than the UUI score.&#xD;
&#xD;
          -  Predominantly UUI&#xD;
&#xD;
          -  Prolapse greater than mild&#xD;
&#xD;
          -  Hysterectomy or other pelvic floor surgery other than a Caesarian section&#xD;
&#xD;
          -  Diabetes,&#xD;
&#xD;
          -  Pregnant,&#xD;
&#xD;
          -  BMI&gt;35 or unable to perform ten &quot;jumping jack&quot; exercises.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Huang W, Wang T, Zong H, Zhang Y. Efficacy and Safety of Tension-Free Vaginal Tape-Secur Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis. Int Neurourol J. 2015 Dec;19(4):246-58. doi: 10.5213/inj.2015.19.4.246. Epub 2015 Dec 28.</citation>
    <PMID>26739179</PMID>
  </reference>
  <reference>
    <citation>Ellington DR, Erekson EA, Richter HE. Outcomes of Surgery for Stress Urinary Incontinence in the Older Woman. Clin Geriatr Med. 2015 Nov;31(4):487-505. doi: 10.1016/j.cger.2015.06.006. Epub 2015 Jul 26.</citation>
    <PMID>26476111</PMID>
  </reference>
  <reference>
    <citation>Jones KA, Harmanli O. Pessary use in pelvic organ prolapse and urinary incontinence. Rev Obstet Gynecol. 2010 Winter;3(1):3-9.</citation>
    <PMID>20508777</PMID>
  </reference>
  <reference>
    <citation>Bradley CS, Rahn DD, Nygaard IE, Barber MD, Nager CW, Kenton KS, Siddiqui NY, Abel RB, Spino C, Richter HE. The questionnaire for urinary incontinence diagnosis (QUID): validity and responsiveness to change in women undergoing non-surgical therapies for treatment of stress predominant urinary incontinence. Neurourol Urodyn. 2010 Jun;29(5):727-34. doi: 10.1002/nau.20818.</citation>
    <PMID>19787711</PMID>
  </reference>
  <reference>
    <citation>Hahn I, Fall M. Objective Quantification of Stress Urinary Incontinence: A Short Reproducible, Provocative Pad-Test. Neurourology and urodynamics. 1991;10:475-81.</citation>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>May 8, 2017</results_first_submitted>
  <results_first_submitted_qc>October 5, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 6, 2017</results_first_posted>
  <last_update_submitted>January 4, 2018</last_update_submitted>
  <last_update_submitted_qc>January 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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>December 14, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03010800/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>December 14, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03010800/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>With Yoni.Fit First</title>
          <description>Yoni.Fit first, then without the Yoni.Fit.</description>
        </group>
        <group group_id="P2">
          <title>Without Yoni.Fit First</title>
          <description>Without Yoni.Fit first, then with Yoni.Fit.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Initial Assignment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Cross Over</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>With Yoni.Fit First</title>
          <description>With the Yoni.Fit first, then without the Yoni.Fit.</description>
        </group>
        <group group_id="B2">
          <title>Without Yoni.Fit First</title>
          <description>Without the Yoni.Fit first, then with the Yoni.Fit.</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="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="4"/>
                    <count group_id="B2" value="4"/>
                    <count group_id="B3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_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="4"/>
                    <count group_id="B2" value="4"/>
                    <count group_id="B3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pad Weight Difference</title>
        <description>Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.</description>
        <time_frame>An hour after finishing a liter of liquid</time_frame>
        <group_list>
          <group group_id="O1">
            <title>With Yoni.Fit</title>
            <description>Pad weights for with the Yoni.Fit</description>
          </group>
          <group group_id="O2">
            <title>Without Yoni.Fit</title>
            <description>Pad weights without Yoni.Fit.</description>
          </group>
        </group_list>
        <measure>
          <title>Pad Weight Difference</title>
          <description>Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.</description>
          <units>grams</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subject #1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject #2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject #3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject #4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject #5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1"/>
                    <measurement group_id="O2" value="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject #6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1"/>
                    <measurement group_id="O2" value="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject #7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject #8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3"/>
                    <measurement group_id="O2" value="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis is that the pad weights With Yoni.Fit and Without Yoni.Fit are equivalent.&#xD;
A one-sided Wilcoxson paired T-test of the group means will be performed. If the p-value is significant, the null hypothesis will be rejected.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0469</p_value>
            <p_value_desc>One subject experienced incontinence with the Yoni.Fit in place (#8) (9.2 g Pad Wt. Without and 17.3 g Pad Wt. With). This was attributed to incorrect Yoni.Fit sizing. This subject was not included in the p-value calculation.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>With Yoni.Fit</title>
          <description>Those subjects assigned to use the Yoni.Fit first</description>
        </group>
        <group group_id="E2">
          <title>Without Yoni.Fit</title>
          <description>Those subjects assigned to use the pad first.</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </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>Dr. Robert Hurst</name_or_title>
      <organization>Oklahoma University Health Science Center</organization>
      <phone>405-271-3930</phone>
      <email>Robert-Hurst@ouhsc.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/NCT03010800
org study id: WCP001
nct id: NCT03010800
lead sponsor: 
collaborator: 
has dmc: No
This study will test the acute efficacy of an investigational device (Yoni.Fit) in a clinical
      trial of women with incontinence in a standardized set of challenges performed with and
      without the device in place.
1. Potential subjects will be pre-qualified by a 6-item questionnaire, the validated
           Questionnaire for Urinary Incontinence Diagnosis (QUID). This questionnaire has 3
           questions each referring to the seriousness of Stress Urinary Incontinence (SUI) and of
           Urge Urinary Incontinence (UUI). Subjects will be accepted if their SUI score is 5 or
           greater and is greater than the UUI score. For privacy reasons, these scores will not be
           retained. Subjects will then be given an appointment. Subjects will be instructed to
           wear comfortable athletic type wear and not to drink any fluid for two hours prior to
           their appointment.

        2. When subjects appear for their appointment, subjects will be administered the informed
           consent by the Study Coordinator. All paperwork will be pre-numbered with a code that
           will link to the subject name. The key will be kept confidential by the Study
           Coordinator. They will be instructed to empty their bladders and will be given a liter
           of water or other drink and instructed to drink it over a 15-20 minute time period. An
           abbreviated patient history will be obtained for the purpose of establishing whether the
           subject meets the inclusion criteria and is not disqualified by meeting the exclusion
           criteria. The subject will again fill out the QUID questionnaire. The inclusion criteria
           are a SUI score of 5 or greater, predominately SUI (SUI score>UUI score) and age between
           25 and 65. Exclusion criteria are predominantly UUI, prolapse greater than mild,
           hysterectomy or other pelvic floor surgery other than a Caesarian section, diabetes,
           pregnant, BMI>35 or unable to perform ten "jumping jack" exercises. Patients will be
           administered three additional questionnaires in order to compute a Severity Score. These
           questionnaires are the Urinary Distress Inventory (UDI), Urinary Impact Questionnaire
           (UIQ) and the Incontinence Severity Index (ISI). The scores will be multiplied together
           to provide the Severity Score.

        3. Patients will be randomized to Group A or Group B to participate in an abbreviated Pad
           Test. Group A will perform the test with the Yoni.Fit device in place then repeat the
           test without the device. Group B will perform the test without the Yoni.Fit device in
           place then repeat the test with the device in place. This test has been validated (5).
           An hour after finishing the liter of liquid, the subject is given a tared incontinence
           pad, which is then put in place. She then engages in the following mild exercise
           challenges..

             1. Stand from sitting 10 times.

             2. Cough vigorously while standing.

             3. Bend down to pick up small object.

             4. Perform ten jumping jacks. The subject then will remove pad, place into bag and
                seal. The Experimenter will then weigh pad. The subjects will be randomized so that
                half will perform the Abbreviated Pad Test with the Yoni.Fit device in place
                followed by repeating without the device in place. The other half will perform the
                challenges in the reverse order.

        4. The experimenter will calculate a change in score, which is the weight of the pad worn
           without the device in place minus the tare weight of the pad divided by the weight of
           the pad with the device in place minus the tare weight of the pad. In case no urine is
           released with the device in place, the Improvement Score will be defined as "1000". A
           Release Change will also be calculated as the net weight without the device in place
           minus the weight with the device in place divided by the net weight released without the
           device in place.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Pad Weight Difference
time frame: An hour after finishing a liter of liquid
description: Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.
arm group label: With Yoni.Fit
arm group type: Experimental
description: Subjects will perform the Abbreviated Pad Test with the Yoni.Fit first, then without the Yoni.Fit.
arm group label: Without Yoni.Fit
arm group type: Experimental
description: Subjects will perform the Abbreviated Pad Test without the Yoni.Fit first, then with the Yoni.Fit.
intervention type: Device
intervention name: With Yoni.Fit
description: Abbreviated Pad Test with Yoni.Fit first, then without Yoni.Fit.
arm group label: With Yoni.Fit
intervention type: Device
intervention name: Without Yoni.Fit
description: Abbreviated Pad Test without Yoni.Fit, then with Yoni.Fit.
arm group label: Without Yoni.Fit
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
citation: Huang W, Wang T, Zong H, Zhang Y. Efficacy and Safety of Tension-Free Vaginal Tape-Secur Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis. Int Neurourol J. 2015 Dec;19(4):246-58. doi: 10.5213/inj.2015.19.4.246. Epub 2015 Dec 28.
PMID: 26739179
citation: Ellington DR, Erekson EA, Richter HE. Outcomes of Surgery for Stress Urinary Incontinence in the Older Woman. Clin Geriatr Med. 2015 Nov;31(4):487-505. doi: 10.1016/j.cger.2015.06.006. Epub 2015 Jul 26.
PMID: 26476111
citation: Jones KA, Harmanli O. Pessary use in pelvic organ prolapse and urinary incontinence. Rev Obstet Gynecol. 2010 Winter;3(1):3-9.
PMID: 20508777
citation: Bradley CS, Rahn DD, Nygaard IE, Barber MD, Nager CW, Kenton KS, Siddiqui NY, Abel RB, Spino C, Richter HE. The questionnaire for urinary incontinence diagnosis (QUID): validity and responsiveness to change in women undergoing non-surgical therapies for treatment of stress predominant urinary incontinence. Neurourol Urodyn. 2010 Jun;29(5):727-34. doi: 10.1002/nau.20818.
PMID: 19787711
citation: Hahn I, Fall M. Objective Quantification of Stress Urinary Incontinence: A Short Reproducible, Provocative Pad-Test. Neurourology and urodynamics. 1991;10:475-81.
responsible party type: Sponsor
mesh term: Urinary Incontinence, Stress
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 