<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/NCT04503850</url>
  </required_header>
  <id_info>
    <org_study_id>Cairo University Hospitals</org_study_id>
    <nct_id>NCT04503850</nct_id>
  </id_info>
  <brief_title>Impact of Mirabegron on Erectile Function in BPH Patients</brief_title>
  <official_title>Impact of Beta 3 Agonist Mirabegron on Erectile Function on Patients With Benign Prostate Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of impact of Mirabegron on erectile function for patients treated for BPH&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 patients (Group A) will receive Mirabegron &amp; alpha blocker 50 patients (Group B) will&#xD;
      receive alpha blocker only Evaluation using IIEF 5 scoring system&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of Mirabegron on erectile function</measure>
    <time_frame>6 months</time_frame>
    <description>Using international index of erectile function 5 score system , least score 5 means severe erectile dysfunction and highest score 25 means no erectile dysfunction</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Males With Benign Prostatic Hyperplasia Symptoms</condition>
  <arm_group>
    <arm_group_label>Group A Mirabegron</arm_group_label>
    <description>50 patients receiving Mirabegron 50 mg once daily &amp; alpha blocker</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B alpha blocker only</arm_group_label>
    <description>50 patients receiving alpha blocker only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirabegron 50 MG</intervention_name>
    <description>Mirabegron 50 mg daily dose and follow Up of erectile function using international index of erectile function 5 scoring system</description>
    <arm_group_label>Group A Mirabegron</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alpha Blockers</intervention_name>
    <description>Alpha blocker daily and evaluation of erectile function using international index of erectile function 5 scoring system</description>
    <arm_group_label>Group B alpha blocker only</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All males above age of 50 with LUTS due to BPH&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All males above age 50 with LUTS due to BPH not candidate for prostatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  males below age 50&#xD;
&#xD;
          -  neurologic abnormality&#xD;
&#xD;
          -  Any indication for prostatectomy&#xD;
&#xD;
          -  abnormal bladder contractility i.e diabetics&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Samer Morsy</investigator_full_name>
    <investigator_title>Urology Consultant</investigator_title>
  </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>Mirabegron</mesh_term>
    <mesh_term>Adrenergic alpha-Antagonists</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04503850
org study id: Cairo University Hospitals
nct id: NCT04503850
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Evaluation of impact of Mirabegron on erectile function for patients treated for BPH
50 patients (Group A) will receive Mirabegron & alpha blocker 50 patients (Group B) will
      receive alpha blocker only Evaluation using IIEF 5 scoring system
observational model: Other
time perspective: Prospective
measure: Impact of Mirabegron on erectile function
time frame: 6 months
description: Using international index of erectile function 5 score system , least score 5 means severe erectile dysfunction and highest score 25 means no erectile dysfunction
arm group label: Group A Mirabegron
description: 50 patients receiving Mirabegron 50 mg once daily & alpha blocker
arm group label: Group B alpha blocker only
description: 50 patients receiving alpha blocker only
intervention type: Drug
intervention name: Mirabegron 50 MG
description: Mirabegron 50 mg daily dose and follow Up of erectile function using international index of erectile function 5 scoring system
arm group label: Group A Mirabegron
intervention type: Drug
intervention name: Alpha Blockers
description: Alpha blocker daily and evaluation of erectile function using international index of erectile function 5 scoring system
arm group label: Group B alpha blocker only
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Samer Morsy
investigator title: Urology Consultant
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Mirabegron
mesh term: Adrenergic alpha-Antagonists
sharing ipd: Undecided