<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/NCT01715571</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00130002</org_study_id>
    <nct_id>NCT01715571</nct_id>
  </id_info>
  <brief_title>Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate ED</brief_title>
  <official_title>Clinical and Physiological Assessment of Noninvasive Penile Afferent Vibratory Stimulation of Both Surfaces of the Penis Using the Viberect® Device in Men With Mild to Moderate ED</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess the safety, acceptability, and satisfaction&#xD;
      of penile vibratory stimulation in treatment of erectile dysfunction (ED). The secondary&#xD;
      objective is to demonstrate subjective physiological response (erection, rigidity, orgasm)&#xD;
      after four weeks of frequent device use and the satisfaction of penile erection and sexual&#xD;
      intercourse with partner.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ED is the inability to develop and maintain an erection for satisfactory sexual intercourse&#xD;
      or activity. ED is a highly prevalent medical condition often associated with multiple&#xD;
      causes. It is estimated that more than 50 million American men suffer from mild/moderate to&#xD;
      severe ED. Roughly 50% of men in their 50's, 60% of men in their 60's, and 70% of men in&#xD;
      their 70's suffer from ED. The economic impact of ED is in the billions of dollars. More than&#xD;
      5 billion dollars a year are spent on the pro-erectile medications currently in the market.&#xD;
&#xD;
      Penile vibratory stimulation mimics rapid and repetitive manual/hand stimulation of the&#xD;
      penis. Vibratory stimulation of genitalia is considered safe by the medical community with&#xD;
      important benefits including treatment of orgasmic dysfunction and stress urinary&#xD;
      incontinence. No significant physical or emotional side-effects have been reported in the&#xD;
      medical literature. A recent epidemiological study of the use of vibrators by American women&#xD;
      and men has shown no complaints, and generally high satisfaction and improvement in sexual&#xD;
      response.&#xD;
&#xD;
      Penile erection is controlled by spinal autonomic centers, the activity of which is dependent&#xD;
      on input from supraspinal centers and the genitalia. From a neurophysiological viewpoint,&#xD;
      scientists believe that penile erection is a culmination of multiple successful nerve&#xD;
      reflexes that initiate a vascular event. Simultaneous vibratory stimulation of both surfaces&#xD;
      of the penis at high frequency (70-110 Hz) for 7-10 minutes can lead to gradual filling of&#xD;
      the penis with arterial blood within minutes by activating the pudendo-cavernosal reflex.&#xD;
      Additional physiological effects include progressive rhythmic contraction of the perineal&#xD;
      muscles via the bulbocavernosus reflex, which helps in strengthening rigidity of erection.&#xD;
      This will prepare the user for successful sexual intercourse. Subsequent orgasm and&#xD;
      ejaculation can be very strong and amplified due to stronger contraction of the&#xD;
      bulbospongiosus muscle and activation of higher ejaculatory centers.&#xD;
&#xD;
      This study will assess daily or on-demand ease of use, safety, satisfaction, and efficacy of&#xD;
      the home use of the Food and Drug Administration (FDA) cleared Viberect device by men with&#xD;
      mild to moderate ED&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to obtain adequate recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">March 1, 2013</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire</measure>
    <time_frame>baseline</time_frame>
    <description>The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 &quot;no satisfaction or dissatisfaction&quot; to 4 &quot;high satisfaction.&quot; Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of Use of the Viberect as Assessed by TSS</measure>
    <time_frame>Baseline</time_frame>
    <description>The Treatment Satisfaction Scale (TSS) questionnaire (patient baseline module) will be administered addressing participant satisfaction before Viberect treatment; This is an 8 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 8-40 with higher scores indicating greater dissatisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire</measure>
    <time_frame>Week 4</time_frame>
    <description>The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 &quot;no satisfaction or dissatisfaction&quot; to 4 &quot;high satisfaction.&quot; Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of Use of the Viberect as Assessed by TSS</measure>
    <time_frame>week 4</time_frame>
    <description>The Treatment Satisfaction Scale (TSS) questionnaire (patient active treatment module) will be administered addressing participant satisfaction following Viberect treatment; This is a 13 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 13-65 with higher scores indicating greater dissatisfaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire</measure>
    <time_frame>baseline</time_frame>
    <description>The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EF as Assessed by the Erectile Hardness Score (EHS)</measure>
    <time_frame>baseline</time_frame>
    <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire</measure>
    <time_frame>Week 4</time_frame>
    <description>The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EF as Assessed by the Erectile Hardness Score (EHS)</measure>
    <time_frame>Week 4</time_frame>
    <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Organic Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Viberect treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm have documented mild to moderate ED of organic etiology and will be given the Viberect device for 4 weeks of daily home use in preparation for sexual activity. Men will be asked to use the device and attempt sexual intercourse at least 3 times weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Viberect</intervention_name>
    <description>Men will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart.&#xD;
Men will record device use and intercourse attempts after device use in a diary.</description>
    <arm_group_label>Viberect treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  mild-moderate erectile dysfunction based on International Index of Erectile Function&#xD;
             (IIEF) erectile function score 13-25&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Men with neurological disease&#xD;
&#xD;
          -  IIEF score less than 13&#xD;
&#xD;
          -  Spinal cord injury&#xD;
&#xD;
          -  History of priapism&#xD;
&#xD;
          -  Pelvic neuropathy&#xD;
&#xD;
          -  Post-prostatectomy&#xD;
&#xD;
          -  Penile skin lesions or ulcers&#xD;
&#xD;
          -  Inability to understand and demonstrate device use instructions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arthur L Burnett, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frederick Urology Specialists</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>May 14, 2021</results_first_submitted>
  <results_first_submitted_qc>June 21, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 23, 2021</results_first_posted>
  <last_update_submitted>June 21, 2021</last_update_submitted>
  <last_update_submitted_qc>June 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>erectile dysfunction</keyword>
  <keyword>vibratory stimulation</keyword>
  <keyword>viberect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT01715571/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 7, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT01715571/SAP_001.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>July 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT01715571/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Viberect Treatment</title>
          <description>Single-center, non-randomized, single-arm study The Viberect device was used for 7-10 minutes at least 3 times each week, at least 24 hours apart, 4 weeks period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Viberect Treatment</title>
          <description>Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.9" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire</title>
        <description>The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 &quot;no satisfaction or dissatisfaction&quot; to 4 &quot;high satisfaction.&quot; Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viberect Treatment</title>
            <description>Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire</title>
          <description>The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 &quot;no satisfaction or dissatisfaction&quot; to 4 &quot;high satisfaction.&quot; Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability of Use of the Viberect as Assessed by TSS</title>
        <description>The Treatment Satisfaction Scale (TSS) questionnaire (patient baseline module) will be administered addressing participant satisfaction before Viberect treatment; This is an 8 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 8-40 with higher scores indicating greater dissatisfaction.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viberect Treatment</title>
            <description>Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of Use of the Viberect as Assessed by TSS</title>
          <description>The Treatment Satisfaction Scale (TSS) questionnaire (patient baseline module) will be administered addressing participant satisfaction before Viberect treatment; This is an 8 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 8-40 with higher scores indicating greater dissatisfaction.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire</title>
        <description>The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 &quot;no satisfaction or dissatisfaction&quot; to 4 &quot;high satisfaction.&quot; Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.</description>
        <time_frame>Week 4</time_frame>
        <population>Patient 1 data is missing.</population>
        <group_list>
          <group group_id="O1">
            <title>Viberect Treatment</title>
            <description>Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire</title>
          <description>The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 &quot;no satisfaction or dissatisfaction&quot; to 4 &quot;high satisfaction.&quot; Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.</description>
          <population>Patient 1 data is missing.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability of Use of the Viberect as Assessed by TSS</title>
        <description>The Treatment Satisfaction Scale (TSS) questionnaire (patient active treatment module) will be administered addressing participant satisfaction following Viberect treatment; This is a 13 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 13-65 with higher scores indicating greater dissatisfaction.</description>
        <time_frame>week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viberect Treatment</title>
            <description>Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of Use of the Viberect as Assessed by TSS</title>
          <description>The Treatment Satisfaction Scale (TSS) questionnaire (patient active treatment module) will be administered addressing participant satisfaction following Viberect treatment; This is a 13 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 13-65 with higher scores indicating greater dissatisfaction.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire</title>
        <description>The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viberect Treatment</title>
            <description>Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity</description>
          </group>
        </group_list>
        <measure>
          <title>Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire</title>
          <description>The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EF as Assessed by the Erectile Hardness Score (EHS)</title>
        <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viberect Treatment</title>
            <description>Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity</description>
          </group>
        </group_list>
        <measure>
          <title>EF as Assessed by the Erectile Hardness Score (EHS)</title>
          <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire</title>
        <description>The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viberect Treatment</title>
            <description>Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity</description>
          </group>
        </group_list>
        <measure>
          <title>EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire</title>
          <description>The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" spread="1.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EF as Assessed by the Erectile Hardness Score (EHS)</title>
        <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viberect Treatment</title>
            <description>Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity</description>
          </group>
        </group_list>
        <measure>
          <title>EF as Assessed by the Erectile Hardness Score (EHS)</title>
          <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.66" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Viberect Treatment</title>
          <description>Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity</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="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </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="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Among the limitations of this study are the small number of subjects, short duration of therapy, and a single-arm design with no control group.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Arthur Burnett, MD</name_or_title>
      <organization>Johns Hopkins University School of Medicine</organization>
      <phone>410-614-3986</phone>
      <email>aburnet1@jhmi.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/NCT01715571
org study id: IRB00130002
nct id: NCT01715571
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The primary objective of this study is to assess the safety, acceptability, and satisfaction
      of penile vibratory stimulation in treatment of erectile dysfunction (ED). The secondary
      objective is to demonstrate subjective physiological response (erection, rigidity, orgasm)
      after four weeks of frequent device use and the satisfaction of penile erection and sexual
      intercourse with partner.
ED is the inability to develop and maintain an erection for satisfactory sexual intercourse
      or activity. ED is a highly prevalent medical condition often associated with multiple
      causes. It is estimated that more than 50 million American men suffer from mild/moderate to
      severe ED. Roughly 50% of men in their 50's, 60% of men in their 60's, and 70% of men in
      their 70's suffer from ED. The economic impact of ED is in the billions of dollars. More than
      5 billion dollars a year are spent on the pro-erectile medications currently in the market.

      Penile vibratory stimulation mimics rapid and repetitive manual/hand stimulation of the
      penis. Vibratory stimulation of genitalia is considered safe by the medical community with
      important benefits including treatment of orgasmic dysfunction and stress urinary
      incontinence. No significant physical or emotional side-effects have been reported in the
      medical literature. A recent epidemiological study of the use of vibrators by American women
      and men has shown no complaints, and generally high satisfaction and improvement in sexual
      response.

      Penile erection is controlled by spinal autonomic centers, the activity of which is dependent
      on input from supraspinal centers and the genitalia. From a neurophysiological viewpoint,
      scientists believe that penile erection is a culmination of multiple successful nerve
      reflexes that initiate a vascular event. Simultaneous vibratory stimulation of both surfaces
      of the penis at high frequency (70-110 Hz) for 7-10 minutes can lead to gradual filling of
      the penis with arterial blood within minutes by activating the pudendo-cavernosal reflex.
      Additional physiological effects include progressive rhythmic contraction of the perineal
      muscles via the bulbocavernosus reflex, which helps in strengthening rigidity of erection.
      This will prepare the user for successful sexual intercourse. Subsequent orgasm and
      ejaculation can be very strong and amplified due to stronger contraction of the
      bulbospongiosus muscle and activation of higher ejaculatory centers.

      This study will assess daily or on-demand ease of use, safety, satisfaction, and efficacy of
      the home use of the Food and Drug Administration (FDA) cleared Viberect device by men with
      mild to moderate ED
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire
time frame: baseline
description: The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 "no satisfaction or dissatisfaction" to 4 "high satisfaction." Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.
measure: Acceptability of Use of the Viberect as Assessed by TSS
time frame: Baseline
description: The Treatment Satisfaction Scale (TSS) questionnaire (patient baseline module) will be administered addressing participant satisfaction before Viberect treatment; This is an 8 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 8-40 with higher scores indicating greater dissatisfaction.
measure: Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire
time frame: Week 4
description: The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 "no satisfaction or dissatisfaction" to 4 "high satisfaction." Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.
measure: Acceptability of Use of the Viberect as Assessed by TSS
time frame: week 4
description: The Treatment Satisfaction Scale (TSS) questionnaire (patient active treatment module) will be administered addressing participant satisfaction following Viberect treatment; This is a 13 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 13-65 with higher scores indicating greater dissatisfaction.
measure: Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire
time frame: baseline
description: The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED
measure: EF as Assessed by the Erectile Hardness Score (EHS)
time frame: baseline
description: The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.
measure: EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire
time frame: Week 4
description: The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED
measure: EF as Assessed by the Erectile Hardness Score (EHS)
time frame: Week 4
description: The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.
arm group label: Viberect treatment
arm group type: Experimental
description: Participants in this arm have documented mild to moderate ED of organic etiology and will be given the Viberect device for 4 weeks of daily home use in preparation for sexual activity. Men will be asked to use the device and attempt sexual intercourse at least 3 times weekly
intervention type: Device
intervention name: Viberect
description: Men will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart.
Men will record device use and intercourse attempts after device use in a diary.
arm group label: Viberect treatment
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Arthur L Burnett, MD, MBA
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Erectile Dysfunction
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Among the limitations of this study are the small number of subjects, short duration of therapy, and a single-arm design with no control group.
point of contact: 