<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/NCT03774264</url>
  </required_header>
  <id_info>
    <org_study_id>20180188</org_study_id>
    <nct_id>NCT03774264</nct_id>
  </id_info>
  <brief_title>Treatment Response to Xiaflex for Men With Peyronie's Disease</brief_title>
  <official_title>Treatment Response to Xiaflex Based on Ultrasound Characterization of Plaque for Men With Peyronie's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Endo Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to develop a database of patients with Peyronie's&#xD;
      disease who are treated at the University of Miami. The collected data will help the&#xD;
      researchers to better understand Peyronie's disease and its response to therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2018</start_date>
  <completion_date type="Actual">July 2, 2021</completion_date>
  <primary_completion_date type="Actual">July 2, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Psychosexual changes in Peyronie's Disease Questionnaire (PDQ).</measure>
    <time_frame>52 weeks</time_frame>
    <description>The PDQ is highly responsive to treatment-related change in men with PD. It is self-administered, that measures psychosexual consequences after the presentation of PD. It is intended for men who have had vaginal intercourse in the past 3 months. The range of scores is from 0-24 points, with higher scores signifying greater psychosexual consequences from PD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ).</measure>
    <time_frame>52 weeks</time_frame>
    <description>The PDQ is highly responsive to treatment-related change in men with PD. It measures penile pain in patients with PD. It is intended for men who have had vaginal intercourse in the past 3 months, which evaluate the levels of pain or discomfort based on last erection or vaginal intercourse. The range of scores is from 0-30 points, with higher scores signifying greater penile pain or discomfort.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Goniometer measurement to determine degree of curvature of PD.</measure>
    <time_frame>52 weeks</time_frame>
    <description>Evaluate the total degree change of curvature improvement after treatment with Xiaflex measured by goniometer, an instrument that measures the angle of the curvature to determine the degree of the PD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>International Index of Erectile Function (IIEF) Scores</measure>
    <time_frame>52 weeks</time_frame>
    <description>The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi- dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions, with a range of scores from 0-75, with lower scores signifying poorer erectile function.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Peyronie Disease</condition>
  <arm_group>
    <arm_group_label>Xiaflex group</arm_group_label>
    <description>Patients will be evaluated in our urology clinic at baseline for possible inclusion in our study. All patients at baseline evaluation will be evaluated for duration of symptoms, relationship stability, IIEF and PDQ. All patients will obtain a penile Doppler ultrasound with the aid of a vasoactive substance by a specially trained technician. During this visit, plaque measurements will be taken: location of plaque, distance of plaque from the tip of the penis, degree of curvature measured by goniometer.&#xD;
Ultrasound characteristics will be documented: Type (Type 1: The plaque appears as a thickening of the tunica albuginea without acoustic shadowing. Type 2: A moderately calcified plaque with a typical ultrasound shadow. Type 3: A severely calcified plaque with typical ultrasound shadowing) and Grade of calcification (grade 1 (&lt;0.3 cm), grade 2 (&gt;0.3 cm, &lt;1.5 cm), grade 3 (&gt;1.5 cm; or ≥ 2 plaques &gt;1.0 cm). Sample data sheet attached as appendix 2.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participant with previous diagnosed Peyronie's Disease will be included into the&#xD;
        observational study at the University of Miami, Professional Art Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  A stable relationship for ≥3 months&#xD;
&#xD;
          -  PD symptoms with evidence of stable disease as determined by the investigator&#xD;
&#xD;
          -  Penile curvature deformity of &gt;30° to &lt;90°&#xD;
&#xD;
          -  Has not had previous surgery for PD&#xD;
&#xD;
          -  Has not had previous therapy with Xiaflex for PD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ventral plaque&#xD;
&#xD;
          -  Active phase PD&#xD;
&#xD;
          -  Actively on anticoagulation during time frame of injections&#xD;
&#xD;
          -  Aspirin 81mg will be eligible for therapy&#xD;
&#xD;
          -  Hour glass deformity&#xD;
&#xD;
          -  Previous allergic reaction to Xiaflex&#xD;
&#xD;
          -  Unwilling to participate&#xD;
&#xD;
          -  Medically unfit for sexual intercourse as deemed by the principal investigator&#xD;
&#xD;
          -  Patients scheduled to undergo an elective medical procedure during the investigation&#xD;
             timeframe that will interfere with Xiaflex injection cycles as deemed by the PI&#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>Ranjith Ramasamy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Urology, University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Pawlowska E, Bianek-Bodzak A. Imaging modalities and clinical assesment in men affected with Peyronie's disease. Pol J Radiol. 2011 Jul;76(3):33-7.</citation>
    <PMID>22802839</PMID>
  </reference>
  <reference>
    <citation>Levine L, Rybak J, Corder C, Farrel MR. Peyronie's disease plaque calcification--prevalence, time to identification, and development of a new grading classification. J Sex Med. 2013 Dec;10(12):3121-8. doi: 10.1111/jsm.12334. Epub 2013 Oct 4.</citation>
    <PMID>24119147</PMID>
  </reference>
  <results_reference>
    <citation>Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, Jones N, Kaufman GJ, Carson CC 3rd. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013 Jul;190(1):199-207. doi: 10.1016/j.juro.2013.01.087. Epub 2013 Jan 31.</citation>
    <PMID>23376148</PMID>
  </results_reference>
  <results_reference>
    <citation>Lipshultz LI, Goldstein I, Seftel AD, Kaufman GJ, Smith TM, Tursi JP, Burnett AL. Clinical efficacy of collagenase Clostridium histolyticum in the treatment of Peyronie's disease by subgroup: results from two large, double-blind, randomized, placebo-controlled, phase III studies. BJU Int. 2015 Oct;116(4):650-6. doi: 10.1111/bju.13096. Epub 2015 May 18.</citation>
    <PMID>25711400</PMID>
  </results_reference>
  <results_reference>
    <citation>Kalokairinou K, Konstantinidis C, Domazou M, Kalogeropoulos T, Kosmidis P, Gekas A. US Imaging in Peyronie's Disease. J Clin Imaging Sci. 2012;2:63. doi: 10.4103/2156-7514.103053. Epub 2012 Oct 31.</citation>
    <PMID>23230545</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Ranjith Ramasamy, MD</investigator_full_name>
    <investigator_title>Director of Male Fertility and Andrology, University of Miami</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Penile Induration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03774264
org study id: 20180188
nct id: NCT03774264
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this research study is to develop a database of patients with Peyronie's
      disease who are treated at the University of Miami. The collected data will help the
      researchers to better understand Peyronie's disease and its response to therapy.
observational model: Case-Only
time perspective: Prospective
measure: Psychosexual changes in Peyronie's Disease Questionnaire (PDQ).
time frame: 52 weeks
description: The PDQ is highly responsive to treatment-related change in men with PD. It is self-administered, that measures psychosexual consequences after the presentation of PD. It is intended for men who have had vaginal intercourse in the past 3 months. The range of scores is from 0-24 points, with higher scores signifying greater psychosexual consequences from PD.
measure: Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ).
time frame: 52 weeks
description: The PDQ is highly responsive to treatment-related change in men with PD. It measures penile pain in patients with PD. It is intended for men who have had vaginal intercourse in the past 3 months, which evaluate the levels of pain or discomfort based on last erection or vaginal intercourse. The range of scores is from 0-30 points, with higher scores signifying greater penile pain or discomfort.
measure: Goniometer measurement to determine degree of curvature of PD.
time frame: 52 weeks
description: Evaluate the total degree change of curvature improvement after treatment with Xiaflex measured by goniometer, an instrument that measures the angle of the curvature to determine the degree of the PD.
measure: International Index of Erectile Function (IIEF) Scores
time frame: 52 weeks
description: The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi- dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions, with a range of scores from 0-75, with lower scores signifying poorer erectile function.
arm group label: Xiaflex group
description: Patients will be evaluated in our urology clinic at baseline for possible inclusion in our study. All patients at baseline evaluation will be evaluated for duration of symptoms, relationship stability, IIEF and PDQ. All patients will obtain a penile Doppler ultrasound with the aid of a vasoactive substance by a specially trained technician. During this visit, plaque measurements will be taken: location of plaque, distance of plaque from the tip of the penis, degree of curvature measured by goniometer.
Ultrasound characteristics will be documented: Type (Type 1: The plaque appears as a thickening of the tunica albuginea without acoustic shadowing. Type 2: A moderately calcified plaque with a typical ultrasound shadow. Type 3: A severely calcified plaque with typical ultrasound shadowing) and Grade of calcification (grade 1 (<0.3 cm), grade 2 (>0.3 cm, <1.5 cm), grade 3 (>1.5 cm; or ≥ 2 plaques >1.0 cm). Sample data sheet attached as appendix 2.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ranjith Ramasamy, MD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
citation: Pawlowska E, Bianek-Bodzak A. Imaging modalities and clinical assesment in men affected with Peyronie's disease. Pol J Radiol. 2011 Jul;76(3):33-7.
PMID: 22802839
citation: Levine L, Rybak J, Corder C, Farrel MR. Peyronie's disease plaque calcification--prevalence, time to identification, and development of a new grading classification. J Sex Med. 2013 Dec;10(12):3121-8. doi: 10.1111/jsm.12334. Epub 2013 Oct 4.
PMID: 24119147
citation: Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, Jones N, Kaufman GJ, Carson CC 3rd. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013 Jul;190(1):199-207. doi: 10.1016/j.juro.2013.01.087. Epub 2013 Jan 31.
PMID: 23376148
citation: Lipshultz LI, Goldstein I, Seftel AD, Kaufman GJ, Smith TM, Tursi JP, Burnett AL. Clinical efficacy of collagenase Clostridium histolyticum in the treatment of Peyronie's disease by subgroup: results from two large, double-blind, randomized, placebo-controlled, phase III studies. BJU Int. 2015 Oct;116(4):650-6. doi: 10.1111/bju.13096. Epub 2015 May 18.
PMID: 25711400
citation: Kalokairinou K, Konstantinidis C, Domazou M, Kalogeropoulos T, Kosmidis P, Gekas A. US Imaging in Peyronie's Disease. J Clin Imaging Sci. 2012;2:63. doi: 10.4103/2156-7514.103053. Epub 2012 Oct 31.
PMID: 23230545
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Ranjith Ramasamy, MD
investigator title: Director of Male Fertility and Andrology, University of Miami
mesh term: Penile Induration
sharing ipd: No