<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/NCT03305861</url>
  </required_header>
  <id_info>
    <org_study_id>MD/17.02.26</org_study_id>
    <nct_id>NCT03305861</nct_id>
  </id_info>
  <brief_title>Green LEP vs ThuLEP in Management of Marked Enlarged Prostate</brief_title>
  <official_title>GreenLight (532nm) LASER (XPS) Enucleation vs. Thulium LASER Enucleation of Prostate for Treatment of Benign Prostatic Hyperplasia</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>
      In this study the investigators aim to test TGreenlight (532-nm) laser Photoselective&#xD;
      Enucleation of the Prostate (Green LEP) using (XPS) 180W system ) vs Thulium Laser 200 W&#xD;
      Enucleation of the Prostate (ThuLEP) in reduction of lower urinary tract symptoms (LUTS)&#xD;
      secondary to benign prostatic hyperplasia (BPH) in a randomized controlled trial.&#xD;
      Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes&#xD;
      and complications associated with the procedures will be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transurethral resection of the prostate (TURP) and open simple prostatectomy (SP) have been&#xD;
      the historical reference-standard procedures for prostates &lt; 80 g and ≥ 80 to 100 g,&#xD;
      respectively, for years.&#xD;
&#xD;
      Evolution of LASER technology revived the concept of enucleation, so that the resectoscope&#xD;
      can be used instead of the surgeon's index finger to separate the adenoma from the surgical&#xD;
      capsule mimicking OP. There are several types of laser energy available for enucleation, but&#xD;
      the commonest types are Holmium, Greenlight (532nm) and Thulim YAG LASERS.&#xD;
&#xD;
      Thulium: yttrium-aluminium-garnet laser Thulium LASER works at a wavelength between 1940 and&#xD;
      2013 nm in continuous wave mode so it offers advanced vaporization and hemostatic features.&#xD;
      Different applications and techniques were developed ranging from vapoenucleation technique&#xD;
      with in situ laser assisted resection, so-called Tangerine technique (Thulium Laser resection&#xD;
      of the prostate Tangerine Technique &quot;TmLRP-TT&quot;), and enucleation (ThuVEP/ThuLEP are&#xD;
      published.&#xD;
&#xD;
      Inspite of paucity of RCT comparing ThuLEP to other standard techniques in management of&#xD;
      large prostate, long term outcomes of ThuLEP are so robust. Gross et al reported their 5 year&#xD;
      follow up after ThuVEP in 500 patients with median prostate size of 50 grams. They&#xD;
      demonstrated durable outcomes, with persistent reductions in I-PSS score (5 vs 21), QoL score&#xD;
      (1 vs 4) and improvement in Q max (16.3 vs 6.9 ml/sec). Late complications included urethral&#xD;
      stricture in 3.1%, BNC in 3.1% and recurrent adenoma in 0.6%.&#xD;
&#xD;
      Yang et al published their 5 year results of a RCT comparing ThuLEP vs TURis in 159 patients&#xD;
      with median prostate size of 70 gm. No statistically significant difference between both&#xD;
      groups in terms of IPSS, Qmax or post voiding residual. No patient in either group required&#xD;
      retreatment.&#xD;
&#xD;
      In RCT by Feng et al comparing ThuLEP to PKEP ,with 18 months follow up results , the former&#xD;
      proved to be efficient and safe within 12 months follow-up interval. However, ThuLEP had&#xD;
      significantly better hemostasis parameters and shorter catheterization time.&#xD;
&#xD;
      III GreenLight (532nm) laser system&#xD;
&#xD;
      The Kalium-Titanyl-Phosphate (KTP) and the lithium triborate (LBO) lasers work at a&#xD;
      wavelength of 532 nm. Laser energy is absorbed by haemoglobin, but not by water. Vaporisation&#xD;
      leads to immediate removal of prostatic tissue, relief of BPO, and reduction of LUTS.&#xD;
      GreenLight laser has gained increasing acceptance as a less invasive treatment for lower&#xD;
      urinary tract symptoms due to benign prostatic hyperplasia (BPH/ LUTS).&#xD;
&#xD;
      A meta-analysis of the nine available RCTs comparing PVP using the 80-W and 120-W lasers with&#xD;
      TURP , no differences were found in Qmax and IPSS between 80-W-PVP and TURP, but only two&#xD;
      RCTs provided sufficient 12-month data to be included in the meta-analysis.&#xD;
&#xD;
      With the 180-W (XPS) laser efficacy is comparable to TURP in terms of IPSS, Qmax, post voided&#xD;
      residual volume, prostate volume reduction, PSA decrease and QoL questionnaires. The XPS&#xD;
      laser prostatectomy is superior to TURP in terms of catheterisation time, lengths of hospital&#xD;
      stay and time to stable health status.&#xD;
&#xD;
      In a RCT by Al-Ansari et al comparing HPS 120-W laser PVP versus TURP , the former was&#xD;
      associated with dramatic improvements in all urinary outcomes compared to TURP, but&#xD;
      reintervention rate for recurrent adenomas was 11 % compared to 1.8% in TURP group. All&#xD;
      patients who needed redo surgery had prostate larger than 80 gm.&#xD;
&#xD;
      In another RCT, El-Shal et al of a compared Greenlight laser 180W XPS vapo enucleation ,&#xD;
      where the adenoma is bluntly enucleated partially then vaporized in situ, and HoLEP and&#xD;
      reported 12 months follow up results. Green light XPS vapoenucleation was comparable and non&#xD;
      inferior to HoLEP in symptom improvement. However, at 12 months Q max, prostate size&#xD;
      reduction and PSA reduction were significantly higher in HoLEP group.&#xD;
&#xD;
      These important findings highlighted some limitations in PVP or vapoenucleation such as the&#xD;
      difficulty in determining the anatomical cleavage limits and capsular plain of large&#xD;
      adenomas. These drawbacks are not related to the energy source but to the technique used.&#xD;
&#xD;
      Gomez Sancha described different technique to avoid these limitations which was Greenlight&#xD;
      LASER En-bloc Enucleation of Prostate (Green LEP) where the whole adenoma is dissected from&#xD;
      the surgical capsule and morcellated at the end.&#xD;
&#xD;
      Misrai et al compared Green LEP vs Greenlight PVP for management of prostates larger than 80&#xD;
      gms. At 6 months follow up, IPSS, QoL and PVR improved similarly in both groups but Q max was&#xD;
      significantly higher in Green LEP group. Median percent reduction in prostate size as&#xD;
      measured by TRUS was significantly higher in green LEP (74% vs 57%). Median % reduction of&#xD;
      PSA was 40% and 67% in PVP and Green LEP respectively (p&lt;0.0001).&#xD;
&#xD;
      There is a paucity in studies comparing different types of EEP using different energy sources&#xD;
      other than holmium laser.&#xD;
&#xD;
      Aim of the work In this study the investigators aim to test Thulium Laser 200 W Enucleation&#xD;
      of the Prostate (ThuLEP) vs Greenlight (532-nm) laser Photoselective Enucleation of the&#xD;
      Prostate (Green LEP) using (XPS) 180W system in reduction of LUTS secondary to BPH in a&#xD;
      randomized controlled trial. Furthermore, all peri-operative parameters, urinary flow&#xD;
      parameters, prostate size changes and complications associated with the procedures will be&#xD;
      compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</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>voiding and storage symptoms improvement</measure>
    <time_frame>6 months</time_frame>
    <description>International Prostate Symptom Score (I-PSS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sexual function changes</measure>
    <time_frame>6 months</time_frame>
    <description>International Index of Erectile Function Questionnaire (IIEF)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>6 months</time_frame>
    <description>in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complication</measure>
    <time_frame>12 months</time_frame>
    <description>Clavien-Dindo classification for post-operative complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Prostatic Hyperplasia With Urinary Obstruction</condition>
  <arm_group>
    <arm_group_label>ThuLEP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thulium laser enucleation of prostate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Green LEP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Greenlight laser enucleation of prostate</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ThuLEP</intervention_name>
    <description>Thulium laser enucleation of prostate</description>
    <arm_group_label>ThuLEP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Green LEP</intervention_name>
    <description>Greenlight laser enucleation of prostate</description>
    <arm_group_label>Green LEP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients' age ≥ 40 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 &gt; /= 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 cancer (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>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mahmoud Nabil Laymon, MD</last_name>
    <phone>00201002275698</phone>
    <email>dr_mahmoudlaymon@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Adel M Nabeeh, Professor</last_name>
    <phone>0020100196665</phone>
    <email>adel_nabeeh51@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Urology and Nephrology Center</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>November 20, 2019</last_update_submitted>
  <last_update_submitted_qc>November 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Mahmoud Laymon</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Thulium Laser Enucleation of the Prostate (ThuLEP)</keyword>
  <keyword>Greenlight Laser Enucleation of the Prostate (Green LEP)</keyword>
  <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>
  <!-- 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/NCT03305861
org study id: MD/17.02.26
nct id: NCT03305861
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study the investigators aim to test TGreenlight (532-nm) laser Photoselective
      Enucleation of the Prostate (Green LEP) using (XPS) 180W system ) vs Thulium Laser 200 W
      Enucleation of the Prostate (ThuLEP) in reduction of lower urinary tract symptoms (LUTS)
      secondary to benign prostatic hyperplasia (BPH) in a randomized controlled trial.
      Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes
      and complications associated with the procedures will be compared.
Transurethral resection of the prostate (TURP) and open simple prostatectomy (SP) have been
      the historical reference-standard procedures for prostates < 80 g and ≥ 80 to 100 g,
      respectively, for years.

      Evolution of LASER technology revived the concept of enucleation, so that the resectoscope
      can be used instead of the surgeon's index finger to separate the adenoma from the surgical
      capsule mimicking OP. There are several types of laser energy available for enucleation, but
      the commonest types are Holmium, Greenlight (532nm) and Thulim YAG LASERS.

      Thulium: yttrium-aluminium-garnet laser Thulium LASER works at a wavelength between 1940 and
      2013 nm in continuous wave mode so it offers advanced vaporization and hemostatic features.
      Different applications and techniques were developed ranging from vapoenucleation technique
      with in situ laser assisted resection, so-called Tangerine technique (Thulium Laser resection
      of the prostate Tangerine Technique "TmLRP-TT"), and enucleation (ThuVEP/ThuLEP are
      published.

      Inspite of paucity of RCT comparing ThuLEP to other standard techniques in management of
      large prostate, long term outcomes of ThuLEP are so robust. Gross et al reported their 5 year
      follow up after ThuVEP in 500 patients with median prostate size of 50 grams. They
      demonstrated durable outcomes, with persistent reductions in I-PSS score (5 vs 21), QoL score
      (1 vs 4) and improvement in Q max (16.3 vs 6.9 ml/sec). Late complications included urethral
      stricture in 3.1%, BNC in 3.1% and recurrent adenoma in 0.6%.

      Yang et al published their 5 year results of a RCT comparing ThuLEP vs TURis in 159 patients
      with median prostate size of 70 gm. No statistically significant difference between both
      groups in terms of IPSS, Qmax or post voiding residual. No patient in either group required
      retreatment.

      In RCT by Feng et al comparing ThuLEP to PKEP ,with 18 months follow up results , the former
      proved to be efficient and safe within 12 months follow-up interval. However, ThuLEP had
      significantly better hemostasis parameters and shorter catheterization time.

      III GreenLight (532nm) laser system

      The Kalium-Titanyl-Phosphate (KTP) and the lithium triborate (LBO) lasers work at a
      wavelength of 532 nm. Laser energy is absorbed by haemoglobin, but not by water. Vaporisation
      leads to immediate removal of prostatic tissue, relief of BPO, and reduction of LUTS.
      GreenLight laser has gained increasing acceptance as a less invasive treatment for lower
      urinary tract symptoms due to benign prostatic hyperplasia (BPH/ LUTS).

      A meta-analysis of the nine available RCTs comparing PVP using the 80-W and 120-W lasers with
      TURP , no differences were found in Qmax and IPSS between 80-W-PVP and TURP, but only two
      RCTs provided sufficient 12-month data to be included in the meta-analysis.

      With the 180-W (XPS) laser efficacy is comparable to TURP in terms of IPSS, Qmax, post voided
      residual volume, prostate volume reduction, PSA decrease and QoL questionnaires. The XPS
      laser prostatectomy is superior to TURP in terms of catheterisation time, lengths of hospital
      stay and time to stable health status.

      In a RCT by Al-Ansari et al comparing HPS 120-W laser PVP versus TURP , the former was
      associated with dramatic improvements in all urinary outcomes compared to TURP, but
      reintervention rate for recurrent adenomas was 11 % compared to 1.8% in TURP group. All
      patients who needed redo surgery had prostate larger than 80 gm.

      In another RCT, El-Shal et al of a compared Greenlight laser 180W XPS vapo enucleation ,
      where the adenoma is bluntly enucleated partially then vaporized in situ, and HoLEP and
      reported 12 months follow up results. Green light XPS vapoenucleation was comparable and non
      inferior to HoLEP in symptom improvement. However, at 12 months Q max, prostate size
      reduction and PSA reduction were significantly higher in HoLEP group.

      These important findings highlighted some limitations in PVP or vapoenucleation such as the
      difficulty in determining the anatomical cleavage limits and capsular plain of large
      adenomas. These drawbacks are not related to the energy source but to the technique used.

      Gomez Sancha described different technique to avoid these limitations which was Greenlight
      LASER En-bloc Enucleation of Prostate (Green LEP) where the whole adenoma is dissected from
      the surgical capsule and morcellated at the end.

      Misrai et al compared Green LEP vs Greenlight PVP for management of prostates larger than 80
      gms. At 6 months follow up, IPSS, QoL and PVR improved similarly in both groups but Q max was
      significantly higher in Green LEP group. Median percent reduction in prostate size as
      measured by TRUS was significantly higher in green LEP (74% vs 57%). Median % reduction of
      PSA was 40% and 67% in PVP and Green LEP respectively (p<0.0001).

      There is a paucity in studies comparing different types of EEP using different energy sources
      other than holmium laser.

      Aim of the work In this study the investigators aim to test Thulium Laser 200 W Enucleation
      of the Prostate (ThuLEP) vs Greenlight (532-nm) laser Photoselective Enucleation of the
      Prostate (Green LEP) using (XPS) 180W system in reduction of LUTS secondary to BPH in a
      randomized controlled trial. Furthermore, all peri-operative parameters, urinary flow
      parameters, prostate size changes and complications associated with the procedures will be
      compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: voiding and storage symptoms improvement
time frame: 6 months
description: International Prostate Symptom Score (I-PSS)
measure: sexual function changes
time frame: 6 months
description: International Index of Erectile Function Questionnaire (IIEF)
measure: Operative time
time frame: 6 months
description: in minutes
measure: Postoperative complication
time frame: 12 months
description: Clavien-Dindo classification for post-operative complications
arm group label: ThuLEP
arm group type: Experimental
description: Thulium laser enucleation of prostate
arm group label: Green LEP
arm group type: Experimental
description: Greenlight laser enucleation of prostate
intervention type: Procedure
intervention name: ThuLEP
description: Thulium laser enucleation of prostate
arm group label: ThuLEP
intervention type: Procedure
intervention name: Green LEP
description: Greenlight laser enucleation of prostate
arm group label: Green LEP
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mahmoud Nabil Laymon, MD
phone: 00201002275698
email: dr_mahmoudlaymon@yahoo.com
last name: Adel M Nabeeh, Professor
phone: 0020100196665
email: adel_nabeeh51@hotmail.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Mahmoud Laymon
investigator title: MD
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia