<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/NCT03264482</url>
  </required_header>
  <id_info>
    <org_study_id>THUVAP VS M-TURP</org_study_id>
    <nct_id>NCT03264482</nct_id>
  </id_info>
  <brief_title>High Power Thulium Vaporization vs Transurethral Resection of the Prostate for Treatment of BPH</brief_title>
  <official_title>Treatment of Benign Prostatic Hyperplasia: High Power Thulium Laser Front Fire Vaporization VS Transurethral Resection - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      the investigators plan to test Thulium laser vaporization using high power ( 200w ) Front&#xD;
      fire vaporization compared to standard M-TURP in reduction of LUTS secondary to BPH in a&#xD;
      prospective randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When Lower Urinary Tract Symptoms (LUTS) are refractory to medical therapy and bothersome&#xD;
      enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has&#xD;
      been the historical reference-standard procedures for prostate size between 30-80 ml for&#xD;
      years.&#xD;
&#xD;
      Over the past decade, New minimally invasive surgical therapies (MIST), new medications, and&#xD;
      novel combinations of medical therapies have expanded the number of treatment options ranging&#xD;
      from watchful waiting to open surgery. The range of treatment options is as broad as the BPH&#xD;
      spectrum of symptoms.&#xD;
&#xD;
      These treatment options include prostate vaporization, resection and enucleation using&#xD;
      various energy sources , however the main theme for all these new procedures that they were&#xD;
      done using physiological saline as an irrigant nullifying the risk of TUR syndrome.&#xD;
&#xD;
      One of the biggest changes in surgical treatment of BPH over the past 2 decades has been the&#xD;
      introduction and use of lasers. Two-micron (Thulium) continuous-wave (CW) laser may have&#xD;
      several advantages, including sufficient homeostasis with minimal thermal injury, more&#xD;
      precise tissue incision, and operation in CW/pulsed modes. Pieces of the prostate are&#xD;
      vaporized small enough to evacuate through the resectoscope sheath and use of a mechanical&#xD;
      tissue morcellator is not required.&#xD;
&#xD;
      The introduction of the latest generation of the Thulium laser namely &quot;200w laser &quot; raises&#xD;
      the expectations of the prostate vaporization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2017</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IPSS score at 12 months .</measure>
    <time_frame>12 months</time_frame>
    <description>international prostate symptom score (both voiding &amp; storage symptom subscores )</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>THUVAP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>thulium vaporization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>M-TURP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>monopolar transurethral resection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>M-TURP</intervention_name>
    <description>endoscopic resection of the prostatic adenoma</description>
    <arm_group_label>M-TURP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>THUVAP</intervention_name>
    <description>vaporization of prostatic adenoma via THULIUM laser</description>
    <arm_group_label>THUVAP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients' age ≥50 years&#xD;
&#xD;
          -  LUTS secondary to BOO due to BPH who failed medical treatment&#xD;
&#xD;
          -  International prostate symptom scores (IPSS) &gt;15 and bother score (QOL) ≥ 3 (according&#xD;
             to IPSS question 8)&#xD;
&#xD;
          -  Peak urinary flow rate (Qmax) &lt;15 ml/sec with at least 125 ml voided volume or&#xD;
             Patients with acute urine retention secondary to BPH who failed trial of voiding on&#xD;
             medical treatment.&#xD;
&#xD;
          -  ASA (American society of anaesthesiologists) score ≤3.&#xD;
&#xD;
          -  TRUS prostate size between 30-80 ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with neurological disorder which might affect bladder function as&#xD;
             cerebrovascular stroke, Parkinson disease&#xD;
&#xD;
          -  Active urinary tract infection,&#xD;
&#xD;
          -  Presence of active bladder pathology (within the last 2 years)&#xD;
&#xD;
          -  Known prostate cancer patients will be excluded preoperatively on the basis of digital&#xD;
             rectal examination, prostate specific antigen level, and TRUS imaging followed by&#xD;
             prostate biopsies if necessary.&#xD;
&#xD;
          -  Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or&#xD;
             disorders that affect platelet count or function (e.g., von Willebrand disease) that&#xD;
             would put the subject at risk for intraoperative or postoperative bleeding.&#xD;
&#xD;
          -  Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively&#xD;
             (3-5 d) except for low-dose aspirin (e.g., 100 mg).&#xD;
&#xD;
          -  Patient has had an acute myocardial infarction or open-heart surgery &lt;180 days prior&#xD;
             to the date of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed M. Elshal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology and nephrology center</name>
      <address>
        <city>Al Manşūrah</city>
        <state>DK</state>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>July 24, 2021</last_update_submitted>
  <last_update_submitted_qc>July 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Ahmed Elshal</investigator_full_name>
    <investigator_title>Dr</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>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/NCT03264482
org study id: THUVAP VS M-TURP
nct id: NCT03264482
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the investigators plan to test Thulium laser vaporization using high power ( 200w ) Front
      fire vaporization compared to standard M-TURP in reduction of LUTS secondary to BPH in a
      prospective randomized trial.
When Lower Urinary Tract Symptoms (LUTS) are refractory to medical therapy and bothersome
      enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has
      been the historical reference-standard procedures for prostate size between 30-80 ml for
      years.

      Over the past decade, New minimally invasive surgical therapies (MIST), new medications, and
      novel combinations of medical therapies have expanded the number of treatment options ranging
      from watchful waiting to open surgery. The range of treatment options is as broad as the BPH
      spectrum of symptoms.

      These treatment options include prostate vaporization, resection and enucleation using
      various energy sources , however the main theme for all these new procedures that they were
      done using physiological saline as an irrigant nullifying the risk of TUR syndrome.

      One of the biggest changes in surgical treatment of BPH over the past 2 decades has been the
      introduction and use of lasers. Two-micron (Thulium) continuous-wave (CW) laser may have
      several advantages, including sufficient homeostasis with minimal thermal injury, more
      precise tissue incision, and operation in CW/pulsed modes. Pieces of the prostate are
      vaporized small enough to evacuate through the resectoscope sheath and use of a mechanical
      tissue morcellator is not required.

      The introduction of the latest generation of the Thulium laser namely "200w laser " raises
      the expectations of the prostate vaporization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: IPSS score at 12 months .
time frame: 12 months
description: international prostate symptom score (both voiding & storage symptom subscores )
arm group label: THUVAP
arm group type: Active Comparator
description: thulium vaporization
arm group label: M-TURP
arm group type: Active Comparator
description: monopolar transurethral resection
intervention type: Procedure
intervention name: M-TURP
description: endoscopic resection of the prostatic adenoma
arm group label: M-TURP
intervention type: Procedure
intervention name: THUVAP
description: vaporization of prostatic adenoma via THULIUM laser
arm group label: THUVAP
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed M. Elshal, MD
role: Principal Investigator
affiliation: Mansoura University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Ahmed Elshal
investigator title: Dr
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
sharing ipd: Undecided