<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/NCT02244307</url>
  </required_header>
  <id_info>
    <org_study_id>527.28</org_study_id>
    <nct_id>NCT02244307</nct_id>
  </id_info>
  <brief_title>Observational Study in Patients Suffering From Benign Prostatic Hyperplasia Treated With Alpha-adrenergic Blockade</brief_title>
  <official_title>Evolution of Patients Suffering From Benign Prostatic Hyperplasia (BPH) Treated With Alpha-adrenergic Blockade (JOSEPHINE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The primary objective of this observational study was the assessment of prognosis factors for&#xD;
      having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha&#xD;
      blockers. The secondary objectives were the assessment of the time from alpha-adrenergic&#xD;
      blockade treatment initiation to surgery and the evolution of patients during the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2000</start_date>
  <primary_completion_date type="Actual">June 2003</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of prognosis factors for having recourse to prostatic surgery</measure>
    <time_frame>up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time form alpha-adrenergic blockade treatment initiation to surgery</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of concomitant BPH diseases</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total International Prostate Symptom Score (IPSS)</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with ongoing BPH treatment</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4561</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Patients with BPH treated with alpha-andrenergic blockade</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>alpha-adrenergic blocker</intervention_name>
    <arm_group_label>Patients with BPH treated with alpha-andrenergic blockade</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with BPH for whom alpha-blockade treatement is indicated recruited at general&#xD;
        practitioners&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient with BPH for whom alpha-blocker treatment is indicated&#xD;
&#xD;
          -  Patients who are already on class-1 alpha-blockers can only participate in the study&#xD;
             if all information required is known and/or available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's follow-up not possible&#xD;
&#xD;
          -  Patients participating in another study&#xD;
&#xD;
          -  History of BPH surgery&#xD;
&#xD;
          -  Prostate cancer&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenergic Agents</mesh_term>
    <mesh_term>Adrenergic Antagonists</mesh_term>
    <mesh_term>Adrenergic alpha-Antagonists</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02244307
org study id: 527.28
nct id: NCT02244307
lead sponsor: 
The primary objective of this observational study was the assessment of prognosis factors for
      having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha
      blockers. The secondary objectives were the assessment of the time from alpha-adrenergic
      blockade treatment initiation to surgery and the evolution of patients during the study.
observational model: Cohort
time perspective: Prospective
measure: Assessment of prognosis factors for having recourse to prostatic surgery
time frame: up to 2 years
measure: Time form alpha-adrenergic blockade treatment initiation to surgery
time frame: up to 2 years
measure: Occurrence of concomitant BPH diseases
time frame: up to 2 years
measure: Total International Prostate Symptom Score (IPSS)
time frame: up to 2 years
measure: Percentage of patients with ongoing BPH treatment
time frame: up to 2 years
arm group label: Patients with BPH treated with alpha-andrenergic blockade
intervention type: Drug
intervention name: alpha-adrenergic blocker
arm group label: Patients with BPH treated with alpha-andrenergic blockade
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Adrenergic Agents
mesh term: Adrenergic Antagonists
mesh term: Adrenergic alpha-Antagonists