<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/NCT03756688</url>
  </required_header>
  <id_info>
    <org_study_id>18-006696</org_study_id>
    <nct_id>NCT03756688</nct_id>
  </id_info>
  <brief_title>Penile Length Restoration in Men With Diabetes Mellitus, Type II</brief_title>
  <official_title>Penile Length Restoration in Men With Diabetes Mellitus, Type II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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 objective of the current study is to evaluate the efficacy of a novel penile traction&#xD;
      device in restoring lost penile length in men with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Men with diabetes mellitus experience sexual dysfunctions at an earlier age and higher rate&#xD;
      compared to men without diabetes. One of these sexual dysfunctions includes diminished penile&#xD;
      length. It is currently unknown if the decreased length is due to earlier erectile&#xD;
      dysfunction or secondary to diabetes itself. Penile traction therapy is one of several&#xD;
      treatments which have been used historically to treat decreased penile length, however, to&#xD;
      date, no studies have evaluated the role of traction therapy in men with diabetes. To&#xD;
      accomplish the study, a population of men from Mayo Clinic with a diagnosis of diabetes, type&#xD;
      II will be enrolled and will be randomized to utilize the device for varying amounts of time.&#xD;
      Outcomes will be assessed at the 3 and 6 month time points, and the results are to be used&#xD;
      with the intent to publish in a scientific journal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2018</start_date>
  <completion_date type="Actual">March 18, 2021</completion_date>
  <primary_completion_date type="Actual">March 18, 2021</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Patients will be randomized into one of four groups:&#xD;
Penile Traction Therapy (PTT) for 30 min 2x/day x 3 months, followed by no treatment x 3 months&#xD;
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
PTT for 30 min 2x/day x 6 months&#xD;
Control (no treatment)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The provider and outcome assessor will be blinded to the patient's study arm for all length assessments. Additionally, the assessor will be blinded to prior length measurements.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Penile Length Change Between Baseline and Month 6</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Compliance With Traction Therapy</measure>
    <time_frame>6 months</time_frame>
    <description>Records of use from daily journals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Satisfaction With Traction Therapy at 6 Months.</measure>
    <time_frame>6 months</time_frame>
    <description>Likert scale used to assess self-reported overall satisfaction; 1-10 (10 = maximum satisfaction); higher values signify a better outcome. Satisfaction was assessed at 6 months post-prostatectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events With Use of RestoreX</measure>
    <time_frame>3 and 6 months post-prostatectomy</time_frame>
    <description>Adverse events were assessed at 3- and 6-months post-prostatectomy, with results summed and reported as a total.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With De-novo Peyronie's Disease Development</measure>
    <time_frame>6 months</time_frame>
    <description>Subjective question to determine if the patient has developed any new penile curvature, indentation, deformity, or other findings consistent with Peyronie's Disease during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Comparison of Changes in Penile Length</measure>
    <time_frame>6 months</time_frame>
    <description>Subjective questions on patient perceived improvement in length (yes/no, qualitative [large, medium, small, none]); note that some groups add to &gt;100% due to the effects of rounding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Standardized questionnaire assessment of erectile function (International Index of Erectile Function standardized questionnaire, Erectile Function Domain [questions 1-5 and 15]). Higher scores are better. Assessments were obtained at baseline and at 6 months post-prostatectomy with the result reported being 6 months minus baseline. Minimum score for the change since baseline = -29 (i.e. 1 minus 30), maximum score = 29 (i.e. 30 minus 1)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Penile Diseases</condition>
  <arm_group>
    <arm_group_label>Group 1: Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No treatment will be administered for the entirety of the study (6 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PTT for 30 min 2x day x 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RestoreX PTT - 6 months</intervention_name>
    <description>Penile traction therapy in straight position for all 6 months.</description>
    <arm_group_label>Group 3: Treatment</arm_group_label>
    <arm_group_label>Group 4: Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RestoreX PTT - 3 months</intervention_name>
    <description>Penile traction therapy in straight position for first phase (3 months)</description>
    <arm_group_label>Group 2: Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Men with Diabetes Mellitus, Type II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any evidence of end-organ failure attributed to DM (assessed based on medical history&#xD;
             / patient history alone)&#xD;
&#xD;
          -  Loss of fingers / toes.&#xD;
&#xD;
          -  CKD Stage IV or greater.&#xD;
&#xD;
          -  Retinopathy&#xD;
&#xD;
          -  Myocardial infarction.&#xD;
&#xD;
          -  Cerebrovascular accident.&#xD;
&#xD;
          -  Indwelling penile prosthesis or prior history of penile prosthesis.&#xD;
&#xD;
          -  Peyronie's disease at baseline.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Ziegelmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 24, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>December 21, 2022</results_first_submitted>
  <results_first_submitted_qc>February 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2023</results_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Matthew (Matt) J. Ziegelmann</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Penile Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03756688/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1: Control</title>
          <description>No treatment will be administered for the entirety of the study (6 months)</description>
        </group>
        <group group_id="P2">
          <title>Group 2: Treatment</title>
          <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months&#xD;
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)</description>
        </group>
        <group group_id="P3">
          <title>Group 3: Treatment</title>
          <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
        </group>
        <group group_id="P4">
          <title>Group 4: Treatment</title>
          <description>PTT for 30 min 2x day x 6 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1: Control</title>
          <description>No treatment will be administered for the entirety of the study (6 months)</description>
        </group>
        <group group_id="B2">
          <title>Group 2: Treatment</title>
          <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months&#xD;
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)</description>
        </group>
        <group group_id="B3">
          <title>Group 3: Treatment</title>
          <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
        </group>
        <group group_id="B4">
          <title>Group 4: Treatment</title>
          <description>PTT for 30 min 2x day x 6 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
        </group>
        <group group_id="B5">
          <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="28"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="27"/>
            <count group_id="B4" value="27"/>
            <count group_id="B5" value="110"/>
          </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="28"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="27"/>
                    <count group_id="B4" value="27"/>
                    <count group_id="B5" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.5" spread="7.0"/>
                    <measurement group_id="B2" value="55.1" spread="5.3"/>
                    <measurement group_id="B3" value="55.0" spread="6.3"/>
                    <measurement group_id="B4" value="56.2" spread="5.4"/>
                    <measurement group_id="B5" value="54.9" spread="6.1"/>
                  </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="28"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="27"/>
                    <count group_id="B4" value="27"/>
                    <count group_id="B5" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="110"/>
                  </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 group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Penile Length Change Between Baseline and Month 6</title>
        <description>Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.</description>
        <time_frame>Baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Control</title>
            <description>No treatment will be administered for the entirety of the study (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Treatment</title>
            <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months&#xD;
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Treatment</title>
            <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: Treatment</title>
            <description>PTT for 30 min 2x day x 6 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Penile Length Change Between Baseline and Month 6</title>
          <description>Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.</description>
          <units>Median change from baseline (cm)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-0.5" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.5" lower_limit="-0.3" upper_limit="0.9"/>
                    <measurement group_id="O3" value="0.5" lower_limit="0" upper_limit="1.5"/>
                    <measurement group_id="O4" value="0.8" lower_limit="0" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Compliance With Traction Therapy</title>
        <description>Records of use from daily journals</description>
        <time_frame>6 months</time_frame>
        <population>No patients were analyzed in the control arm since the outcome measure was assessing compliance with traction therapy (not administered to controls).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Control</title>
            <description>No treatment will be administered for the entirety of the study (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Treatment</title>
            <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months&#xD;
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Treatment</title>
            <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: Treatment</title>
            <description>PTT for 30 min 2x day x 6 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Compliance With Traction Therapy</title>
          <description>Records of use from daily journals</description>
          <population>No patients were analyzed in the control arm since the outcome measure was assessing compliance with traction therapy (not administered to controls).</population>
          <units>Percent compliance</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="93.5" spread="9.7"/>
                    <measurement group_id="O3" value="91.5" spread="14.3"/>
                    <measurement group_id="O4" value="85.2" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Reported Satisfaction With Traction Therapy at 6 Months.</title>
        <description>Likert scale used to assess self-reported overall satisfaction; 1-10 (10 = maximum satisfaction); higher values signify a better outcome. Satisfaction was assessed at 6 months post-prostatectomy.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 2: Treatment</title>
            <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months&#xD;
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)</description>
          </group>
          <group group_id="O2">
            <title>Group 3: Treatment</title>
            <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
          <group group_id="O3">
            <title>Group 4: Treatment</title>
            <description>PTT for 30 min 2x day x 6 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Satisfaction With Traction Therapy at 6 Months.</title>
          <description>Likert scale used to assess self-reported overall satisfaction; 1-10 (10 = maximum satisfaction); higher values signify a better outcome. Satisfaction was assessed at 6 months post-prostatectomy.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="4.3" upper_limit="9"/>
                    <measurement group_id="O2" value="8" lower_limit="6" upper_limit="9"/>
                    <measurement group_id="O3" value="8" lower_limit="6.3" upper_limit="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events With Use of RestoreX</title>
        <description>Adverse events were assessed at 3- and 6-months post-prostatectomy, with results summed and reported as a total.</description>
        <time_frame>3 and 6 months post-prostatectomy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 2: Treatment</title>
            <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months&#xD;
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)</description>
          </group>
          <group group_id="O2">
            <title>Group 3: Treatment</title>
            <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
          <group group_id="O3">
            <title>Group 4: Treatment</title>
            <description>PTT for 30 min 2x day x 6 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events With Use of RestoreX</title>
          <description>Adverse events were assessed at 3- and 6-months post-prostatectomy, with results summed and reported as a total.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Temporary penile pain (mild)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain in other location (unclear if related)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temporary erythema / discoloration (mild)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temporary decreased sensation (mild)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other (unclear if related)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temporary bleeding from tape (mild)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With De-novo Peyronie's Disease Development</title>
        <description>Subjective question to determine if the patient has developed any new penile curvature, indentation, deformity, or other findings consistent with Peyronie's Disease during the study period</description>
        <time_frame>6 months</time_frame>
        <population>Note that reported events represent subjective reporting of penile curvature.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Control</title>
            <description>No treatment will be administered for the entirety of the study (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Treatment</title>
            <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months&#xD;
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Treatment</title>
            <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: Treatment</title>
            <description>PTT for 30 min 2x day x 6 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With De-novo Peyronie's Disease Development</title>
          <description>Subjective question to determine if the patient has developed any new penile curvature, indentation, deformity, or other findings consistent with Peyronie's Disease during the study period</description>
          <population>Note that reported events represent subjective reporting of penile curvature.</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="23"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Comparison of Changes in Penile Length</title>
        <description>Subjective questions on patient perceived improvement in length (yes/no, qualitative [large, medium, small, none]); note that some groups add to &gt;100% due to the effects of rounding.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Control</title>
            <description>No treatment will be administered for the entirety of the study (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Treatment</title>
            <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months&#xD;
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Treatment</title>
            <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: Treatment</title>
            <description>PTT for 30 min 2x day x 6 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Comparison of Changes in Penile Length</title>
          <description>Subjective questions on patient perceived improvement in length (yes/no, qualitative [large, medium, small, none]); note that some groups add to &gt;100% due to the effects of rounding.</description>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjective improvement in length (% yes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="63"/>
                    <measurement group_id="O4" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjective improvement in length (% unsure)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjective improvement in length (no)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjective improvement (large)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjective improvement (medium)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjective improvement (small)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="82"/>
                    <measurement group_id="O4" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjective improvement (none)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.</title>
        <description>Standardized questionnaire assessment of erectile function (International Index of Erectile Function standardized questionnaire, Erectile Function Domain [questions 1-5 and 15]). Higher scores are better. Assessments were obtained at baseline and at 6 months post-prostatectomy with the result reported being 6 months minus baseline. Minimum score for the change since baseline = -29 (i.e. 1 minus 30), maximum score = 29 (i.e. 30 minus 1)</description>
        <time_frame>Baseline and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Control</title>
            <description>No treatment will be administered for the entirety of the study (6 months)</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Treatment</title>
            <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months&#xD;
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Treatment</title>
            <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: Treatment</title>
            <description>PTT for 30 min 2x day x 6 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.</title>
          <description>Standardized questionnaire assessment of erectile function (International Index of Erectile Function standardized questionnaire, Erectile Function Domain [questions 1-5 and 15]). Higher scores are better. Assessments were obtained at baseline and at 6 months post-prostatectomy with the result reported being 6 months minus baseline. Minimum score for the change since baseline = -29 (i.e. 1 minus 30), maximum score = 29 (i.e. 30 minus 1)</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="25"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="3.3"/>
                    <measurement group_id="O2" value="1.1" spread="4.6"/>
                    <measurement group_id="O3" value="4.2" spread="10.4"/>
                    <measurement group_id="O4" value="4.3" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.</time_frame>
      <desc>The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 2: Treatment</title>
          <description>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months&#xD;
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)</description>
        </group>
        <group group_id="E2">
          <title>Group 3: Treatment</title>
          <description>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</description>
        </group>
        <group group_id="E3">
          <title>Group 4: Treatment</title>
          <description>PTT for 30 min 2x day x 6 months&#xD;
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.</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="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="3" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Transient penile pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Transient penile erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Other pain (non-descript location)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Transient decreased penile sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Temporary bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Other (unclear if related)</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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. Landon Trost</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-202-1995</phone>
      <email>landontrost@gmail.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/NCT03756688
org study id: 18-006696
nct id: NCT03756688
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of the current study is to evaluate the efficacy of a novel penile traction
      device in restoring lost penile length in men with type 2 diabetes.
Men with diabetes mellitus experience sexual dysfunctions at an earlier age and higher rate
      compared to men without diabetes. One of these sexual dysfunctions includes diminished penile
      length. It is currently unknown if the decreased length is due to earlier erectile
      dysfunction or secondary to diabetes itself. Penile traction therapy is one of several
      treatments which have been used historically to treat decreased penile length, however, to
      date, no studies have evaluated the role of traction therapy in men with diabetes. To
      accomplish the study, a population of men from Mayo Clinic with a diagnosis of diabetes, type
      II will be enrolled and will be randomized to utilize the device for varying amounts of time.
      Outcomes will be assessed at the 3 and 6 month time points, and the results are to be used
      with the intent to publish in a scientific journal.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Patients will be randomized into one of four groups:
Penile Traction Therapy (PTT) for 30 min 2x/day x 3 months, followed by no treatment x 3 months
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
PTT for 30 min 2x/day x 6 months
Control (no treatment)
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: The provider and outcome assessor will be blinded to the patient's study arm for all length assessments. Additionally, the assessor will be blinded to prior length measurements.
measure: Penile Length Change Between Baseline and Month 6
time frame: Baseline to 6 months
description: Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.
measure: Patient Compliance With Traction Therapy
time frame: 6 months
description: Records of use from daily journals
measure: Patient Reported Satisfaction With Traction Therapy at 6 Months.
time frame: 6 months
description: Likert scale used to assess self-reported overall satisfaction; 1-10 (10 = maximum satisfaction); higher values signify a better outcome. Satisfaction was assessed at 6 months post-prostatectomy.
measure: Number of Participants With Adverse Events With Use of RestoreX
time frame: 3 and 6 months post-prostatectomy
description: Adverse events were assessed at 3- and 6-months post-prostatectomy, with results summed and reported as a total.
measure: Number of Participants With De-novo Peyronie's Disease Development
time frame: 6 months
description: Subjective question to determine if the patient has developed any new penile curvature, indentation, deformity, or other findings consistent with Peyronie's Disease during the study period
measure: Subjective Comparison of Changes in Penile Length
time frame: 6 months
description: Subjective questions on patient perceived improvement in length (yes/no, qualitative [large, medium, small, none]); note that some groups add to >100% due to the effects of rounding.
measure: Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.
time frame: Baseline and 6 months
description: Standardized questionnaire assessment of erectile function (International Index of Erectile Function standardized questionnaire, Erectile Function Domain [questions 1-5 and 15]). Higher scores are better. Assessments were obtained at baseline and at 6 months post-prostatectomy with the result reported being 6 months minus baseline. Minimum score for the change since baseline = -29 (i.e. 1 minus 30), maximum score = 29 (i.e. 30 minus 1)
arm group label: Group 1: Control
arm group type: No Intervention
description: No treatment will be administered for the entirety of the study (6 months)
arm group label: Group 2: Treatment
arm group type: Experimental
description: PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
arm group label: Group 3: Treatment
arm group type: Experimental
description: PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
arm group label: Group 4: Treatment
arm group type: Experimental
description: PTT for 30 min 2x day x 6 months
intervention type: Device
intervention name: RestoreX PTT - 6 months
description: Penile traction therapy in straight position for all 6 months.
arm group label: Group 3: Treatment
arm group label: Group 4: Treatment
intervention type: Device
intervention name: RestoreX PTT - 3 months
description: Penile traction therapy in straight position for first phase (3 months)
arm group label: Group 2: Treatment
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Ziegelmann, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Matthew (Matt) J. Ziegelmann
investigator title: Principal Investigator
mesh term: Penile Diseases
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 