xml: <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/NCT05982444</url>
    </required_header>
    <id_info>
      <org_study_id>30-2023</org_study_id>
      <nct_id>NCT05982444</nct_id>
    </id_info>
    <brief_title>Long Term Follow up of Water Vapor Thermal Therapy (Rezum) for Benign Prostatic Hyperplasia (BPH)</brief_title>
    <official_title>Long Term Post-operative Effectiveness and Morbidity of Rezum Therapy for Benign Prostatic Hyperplasia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Helwan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Helwan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        in this study the investigators are assessing the effectiveness and morbidity of rezum&#xD;
        therapy for benign prostatic hyperplasia by collect data and assess all patient who treated&#xD;
        by rezum from 2 to 4 years and report these results.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>prostate assessment</measure>
      <time_frame>4 years</time_frame>
      <description>assess prostate volume and post voiding residual by pelvi-abdominal ultrasound</description>
    </primary_outcome>
    <primary_outcome>
      <measure>symptoms assessment</measure>
      <time_frame>4 years</time_frame>
      <description>assess International Prostate Symptom Score (IPSS) from 0 to 7 mild symptoms - from 8 to 19 moderate symptoms and from 20 to 35 sever symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>sexual function</measure>
      <time_frame>4 years</time_frame>
      <description>assess international index of erectile function ( IIEF-5) score (5-7) severe - (8-11) moderate - (12-16) mild to moderate - (17-21) mild - (22-25) no erectile dysfunction</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>durability of procedure</measure>
      <time_frame>4 years</time_frame>
      <description>incidence of prostate retreatment by the same or other procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>complication of procedure</measure>
      <time_frame>4 years</time_frame>
      <description>incidence of urological complications (e.g. urine retention, urethral stricture and hematuria) happen during follow up</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Benign Prostatic Hyperplasia</condition>
    <arm_group>
      <arm_group_label>patient treated by rezum procedure</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>patients had benign prostatic hyperplasia and treated by rezum procedure from 2 to 4 years included in the study</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>water vapor thermal therapy (Rezum) for prostate</intervention_name>
      <description>all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period</description>
      <arm_group_label>patient treated by rezum procedure</arm_group_label>
      <other_name>Prostate steam treatment (Rezum) for benign prostatic hyperplasia (BPH)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients underwent rezum procedure for benign prostatic hyperplasia from 2 to 4 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  previous prostatic intervention&#xD;
  &#xD;
            -  concurrent urological morbidity like urethral stricture&#xD;
  &#xD;
            -  neurological disease like parkinson's disease&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>the disease is conclusive for men</gender_description>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Medicine Helwan University</name>
        <address>
          <city>Helwan</city>
          <state>Cairo</state>
          <zip>11795</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Helwan University</investigator_affiliation>
      <investigator_full_name>Mahmoud Mohammed Elsaid Ali Elshahawy</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>Prostatic Hyperplasia</mesh_term>
      <mesh_term>Hyperplasia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Patients are not permitted to post any of their personal information</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982444
  org study id: 30-2023
  nct id: NCT05982444
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  in this study the investigators are assessing the effectiveness and morbidity of rezum
        therapy for benign prostatic hyperplasia by collect data and assess all patient who treated
        by rezum from 2 to 4 years and report these results.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: prostate assessment
  time frame: 4 years
  description: assess prostate volume and post voiding residual by pelvi-abdominal ultrasound
  measure: symptoms assessment
  time frame: 4 years
  description: assess International Prostate Symptom Score (IPSS) from 0 to 7 mild symptoms - from 8 to 19 moderate symptoms and from 20 to 35 sever symptoms
  measure: sexual function
  time frame: 4 years
  description: assess international index of erectile function ( IIEF-5) score (5-7) severe - (8-11) moderate - (12-16) mild to moderate - (17-21) mild - (22-25) no erectile dysfunction
  measure: durability of procedure
  time frame: 4 years
  description: incidence of prostate retreatment by the same or other procedure.
  measure: complication of procedure
  time frame: 4 years
  description: incidence of urological complications (e.g. urine retention, urethral stricture and hematuria) happen during follow up
  arm group label: patient treated by rezum procedure
  arm group type: Other
  description: patients had benign prostatic hyperplasia and treated by rezum procedure from 2 to 4 years included in the study
  intervention type: Procedure
  intervention name: water vapor thermal therapy (Rezum) for prostate
  description: all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period
  arm group label: patient treated by rezum procedure
  other name: Prostate steam treatment (Rezum) for benign prostatic hyperplasia (BPH)
  criteria: 
  gender: Male
  gender based: Yes
  gender description: the disease is conclusive for men
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Helwan University
  investigator full name: Mahmoud Mohammed Elsaid Ali Elshahawy
  investigator title: Principal Investigator
  mesh term: Prostatic Hyperplasia
  mesh term: Hyperplasia
  sharing ipd: No
  ipd description: Patients are not permitted to post any of their personal information