<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/NCT04471155</url>
  </required_header>
  <id_info>
    <org_study_id>MD/152/2018</org_study_id>
    <nct_id>NCT04471155</nct_id>
  </id_info>
  <brief_title>Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate</brief_title>
  <official_title>Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate More Than 80 Grams in Egyptian Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety&#xD;
      and efficacy in men with prostate larger than 80 grams&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">April 22, 2020</completion_date>
  <primary_completion_date type="Actual">April 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>efficacy by measuring maximum urinary flow rate in millilitre per second</measure>
    <time_frame>1 year</time_frame>
    <description>change of maximum urinary flow rate in mililiter per second pre and post opeartive</description>
  </primary_outcome>
  <primary_outcome>
    <measure>efficacy in american urological association symptom score</measure>
    <time_frame>1 year</time_frame>
    <description>change of american urological association symptom score pre and post operative by scale from 1 to 35</description>
  </primary_outcome>
  <primary_outcome>
    <measure>efficacy of evacuation by measuring post-voiding residual urine volume in millilitre</measure>
    <time_frame>1 year</time_frame>
    <description>change of post-voiding residual urine volume in millilitre</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>safety by doing blood picture to asses hemoglobin drop</measure>
    <time_frame>immediate post-operative</time_frame>
    <description>rate of hemoglobin drop post-operatively by gram per decilitre</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Holep</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient underwent laser prostatectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>open prostatectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient underwent open prostatectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Holep</intervention_name>
    <description>laser enucleation of the gland versus open enucleation</description>
    <arm_group_label>Holep</arm_group_label>
    <arm_group_label>open prostatectomy</arm_group_label>
    <other_name>open prostatectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Urological Association Symptom Score of eight or higher,&#xD;
&#xD;
          -  Maximum urinary flow rate of 10ml/s or less,&#xD;
&#xD;
          -  Post void residual urine volume of 50 ml or more,&#xD;
&#xD;
          -  And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A previous prostate or urethral surgery&#xD;
&#xD;
          -  And non-BPH related voiding disorders&#xD;
&#xD;
          -  Prostate cancer patients&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>only males have prostate</gender_description>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mohamed Alnoomani</name>
      <address>
        <city>Cairo</city>
        <state>القاهرة</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>mohamed alnoomani</investigator_full_name>
    <investigator_title>mohamed nabil alnoomani, assistant lecturer of urology</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>
  <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/NCT04471155
org study id: MD/152/2018
nct id: NCT04471155
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety
      and efficacy in men with prostate larger than 80 grams
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled trial
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: efficacy by measuring maximum urinary flow rate in millilitre per second
time frame: 1 year
description: change of maximum urinary flow rate in mililiter per second pre and post opeartive
measure: efficacy in american urological association symptom score
time frame: 1 year
description: change of american urological association symptom score pre and post operative by scale from 1 to 35
measure: efficacy of evacuation by measuring post-voiding residual urine volume in millilitre
time frame: 1 year
description: change of post-voiding residual urine volume in millilitre
measure: safety by doing blood picture to asses hemoglobin drop
time frame: immediate post-operative
description: rate of hemoglobin drop post-operatively by gram per decilitre
arm group label: Holep
arm group type: Active Comparator
description: patient underwent laser prostatectomy
arm group label: open prostatectomy
arm group type: Active Comparator
description: patient underwent open prostatectomy
intervention type: Procedure
intervention name: Holep
description: laser enucleation of the gland versus open enucleation
arm group label: Holep
arm group label: open prostatectomy
other name: open prostatectomy
criteria: 
gender: Male
gender based: Yes
gender description: only males have prostate
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: mohamed alnoomani
investigator title: mohamed nabil alnoomani, assistant lecturer of urology
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
sharing ipd: No