<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/NCT03230721</url>
  </required_header>
  <id_info>
    <org_study_id>IMSechenovMMA</org_study_id>
    <nct_id>NCT03230721</nct_id>
  </id_info>
  <brief_title>ThuLEP vs. HoLEP vs. Monopolar Enucleation in Management of BPH</brief_title>
  <official_title>Comparative Analysis of the Efficacy and Safety of Thulium-fiber Laser Enucleation, Ho:YAG Laser Enucleation and Monopolar Enucleation in Management of BPH</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I.M. Sechenov First Moscow State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I.M. Sechenov First Moscow State Medical 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>
      Today, endoscopic enucleation of the prostate (EEP) has been recognized a method of choice&#xD;
      for treatment of benign prostatic hyperplasia (BPH) of any size, including large-sized glands&#xD;
      (&gt;80 cc). The goal of our study was to compare perioperative efficacy, functional outcomes&#xD;
      and safety of different techniques of endoscopic enucleation of the prostate (monopolar&#xD;
      enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HoLEP and ThuLEP or EEP have been approved by the current guidelines of the European&#xD;
      Association of Urology for use in men with substantially enlarged prostates (&gt;80 ml) as&#xD;
      first-line therapy [1]. This type of operation can be performed by means of several sources&#xD;
      of energy.&#xD;
&#xD;
      To our knowledge, there were no studies comparing efficacy and complications of these three&#xD;
      treatment modalities.&#xD;
&#xD;
      In this study the investigators have evaluated efficacy of Thulium-fiber laser enucleation&#xD;
      (120 W thulium fiber laser Urolase, IPG IRE-POLUS, Russia with wavelength of 1940 nm) and&#xD;
      monopolar enuclation in comparision with HoLEP (VersaPulse Powersuite 100, Lumenis,&#xD;
      USA/Israel) in reduction of LUTS secondary to BPH in a prospective randomized trial.&#xD;
&#xD;
      All peri-operative parameters, urinary flow parameters, prostate size changes, erectile&#xD;
      function and complications associated with the procedures were compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2015</start_date>
  <completion_date type="Actual">July 21, 2017</completion_date>
  <primary_completion_date type="Actual">April 22, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IPSS</measure>
    <time_frame>Six months</time_frame>
    <description>International Prostate Symptom Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QoL</measure>
    <time_frame>Six months</time_frame>
    <description>Quality of Life Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PVR</measure>
    <time_frame>Six months</time_frame>
    <description>Post-void residual volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qmax</measure>
    <time_frame>Six months</time_frame>
    <description>Maximal urine flow rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IIEF-5</measure>
    <time_frame>Six months</time_frame>
    <description>The International Index of Erectile Function</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">450</enrollment>
  <condition>Prostatic Hyperplasia, Benign</condition>
  <condition>Prostate Adenoma</condition>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>ThuLEP group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who underwent thulium-fiber laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monopolar enucleation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who underwent monopolar enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HoLEP group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who underwent Ho:YAG laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thulium-fiber laser enucleation of the prostate</intervention_name>
    <description>A high-power (120 W) thulium fiber laser (Urolase, IPG IRE-POLUS, Russia) with wavelength of 1940 nm was used for thulium laser enucleation. In our study, we used a 600-μm laser fiber. The operations were performed at power of 60 W energy of 1.5 J and repetition rate of 40 Hz. Laser power in the verumontanum zone was decreased to 30 W and repetition rate to 20 Hz.</description>
    <arm_group_label>ThuLEP group</arm_group_label>
    <other_name>ThuLEP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Monopolar enucleation of the prostate</intervention_name>
    <description>Monopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.</description>
    <arm_group_label>Monopolar enucleation group</arm_group_label>
    <other_name>Monopolar enucleation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ho:YAG laser enucleation of the prostate</intervention_name>
    <description>Holmium laser enucleation of prostatic hyperplasia was performed with a 100 W laser (VersaPulse Powersuite 100, Lumenis, USA/Israel) with wavelength of 2100 nm and 550-μm fiber at the tip. The operation was performed at power of 70 W; it was decreased to 40 W when incisions were made at the verumontanum.</description>
    <arm_group_label>HoLEP group</arm_group_label>
    <other_name>HoLEP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IPSS&gt;20;&#xD;
&#xD;
          -  maximum urinary flow rate&lt; 10ml\s (Qmax);&#xD;
&#xD;
          -  ineffective alfa-blockers therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  histologically verified prostate cancer;&#xD;
&#xD;
          -  history of prostatic surgery;&#xD;
&#xD;
          -  urethral strictures;&#xD;
&#xD;
          -  bladder stones;&#xD;
&#xD;
          -  chronic urinary retention and cystostomy.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dmitry Enikeev, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>I.M. Sechenov First Moscow State Medical University</affiliation>
  </overall_official>
  <reference>
    <citation>Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.</citation>
    <PMID>25613154</PMID>
  </reference>
  <reference>
    <citation>Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.</citation>
    <PMID>24972732</PMID>
  </reference>
  <reference>
    <citation>Glybochko PV, Rapoport LM, Enikeev ME, Enikeev DV. Holmium laser enucleation of the prostate (HoLEP) for small, large and giant prostatic hyperplasia: tips and tricks. Urologia. 2017 Aug 1;84(3):169-173. doi: 10.5301/uj.5000232. Epub 2017 May 10.</citation>
    <PMID>28497447</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>I.M. Sechenov First Moscow State Medical University</investigator_affiliation>
    <investigator_full_name>Dmitry Enikeev, MD, PhD</investigator_full_name>
    <investigator_title>Deputy Director for Sсience, Dept. of Urology, I.M. Sechenov Moscow State Medical University</investigator_title>
  </responsible_party>
  <keyword>laser</keyword>
  <keyword>HoLEP</keyword>
  <keyword>ThuLEP</keyword>
  <keyword>Thulium</keyword>
  <keyword>Thulium-fiber</keyword>
  <keyword>BPH</keyword>
  <keyword>EEP</keyword>
  <keyword>monopolar enucleation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</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/NCT03230721
org study id: IMSechenovMMA
nct id: NCT03230721
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Today, endoscopic enucleation of the prostate (EEP) has been recognized a method of choice
      for treatment of benign prostatic hyperplasia (BPH) of any size, including large-sized glands
      (>80 cc). The goal of our study was to compare perioperative efficacy, functional outcomes
      and safety of different techniques of endoscopic enucleation of the prostate (monopolar
      enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.
HoLEP and ThuLEP or EEP have been approved by the current guidelines of the European
      Association of Urology for use in men with substantially enlarged prostates (>80 ml) as
      first-line therapy [1]. This type of operation can be performed by means of several sources
      of energy.

      To our knowledge, there were no studies comparing efficacy and complications of these three
      treatment modalities.

      In this study the investigators have evaluated efficacy of Thulium-fiber laser enucleation
      (120 W thulium fiber laser Urolase, IPG IRE-POLUS, Russia with wavelength of 1940 nm) and
      monopolar enuclation in comparision with HoLEP (VersaPulse Powersuite 100, Lumenis,
      USA/Israel) in reduction of LUTS secondary to BPH in a prospective randomized trial.

      All peri-operative parameters, urinary flow parameters, prostate size changes, erectile
      function and complications associated with the procedures were compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: IPSS
time frame: Six months
description: International Prostate Symptom Score
measure: QoL
time frame: Six months
description: Quality of Life Score
measure: PVR
time frame: Six months
description: Post-void residual volume
measure: Qmax
time frame: Six months
description: Maximal urine flow rate
measure: IIEF-5
time frame: Six months
description: The International Index of Erectile Function
arm group label: ThuLEP group
arm group type: Active Comparator
description: Patients who underwent thulium-fiber laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
arm group label: Monopolar enucleation group
arm group type: Active Comparator
description: Patients who underwent monopolar enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
arm group label: HoLEP group
arm group type: Active Comparator
description: Patients who underwent Ho:YAG laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
intervention type: Procedure
intervention name: Thulium-fiber laser enucleation of the prostate
description: A high-power (120 W) thulium fiber laser (Urolase, IPG IRE-POLUS, Russia) with wavelength of 1940 nm was used for thulium laser enucleation. In our study, we used a 600-μm laser fiber. The operations were performed at power of 60 W energy of 1.5 J and repetition rate of 40 Hz. Laser power in the verumontanum zone was decreased to 30 W and repetition rate to 20 Hz.
arm group label: ThuLEP group
other name: ThuLEP
intervention type: Procedure
intervention name: Monopolar enucleation of the prostate
description: Monopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.
arm group label: Monopolar enucleation group
other name: Monopolar enucleation
intervention type: Procedure
intervention name: Ho:YAG laser enucleation of the prostate
description: Holmium laser enucleation of prostatic hyperplasia was performed with a 100 W laser (VersaPulse Powersuite 100, Lumenis, USA/Israel) with wavelength of 2100 nm and 550-μm fiber at the tip. The operation was performed at power of 70 W; it was decreased to 40 W when incisions were made at the verumontanum.
arm group label: HoLEP group
other name: HoLEP
criteria: 
gender: Male
gender based: Yes
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Dmitry Enikeev, MD, PhD
role: Principal Investigator
affiliation: I.M. Sechenov First Moscow State Medical University
citation: Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
PMID: 25613154
citation: Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.
PMID: 24972732
citation: Glybochko PV, Rapoport LM, Enikeev ME, Enikeev DV. Holmium laser enucleation of the prostate (HoLEP) for small, large and giant prostatic hyperplasia: tips and tricks. Urologia. 2017 Aug 1;84(3):169-173. doi: 10.5301/uj.5000232. Epub 2017 May 10.
PMID: 28497447
responsible party type: Principal Investigator
investigator affiliation: I.M. Sechenov First Moscow State Medical University
investigator full name: Dmitry Enikeev, MD, PhD
investigator title: Deputy Director for Sсience, Dept. of Urology, I.M. Sechenov Moscow State Medical University
mesh term: Adenoma
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Lower Urinary Tract Symptoms
sharing ipd: No