<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/NCT03776006</url>
  </required_header>
  <id_info>
    <org_study_id>W18_316</org_study_id>
    <nct_id>NCT03776006</nct_id>
  </id_info>
  <brief_title>Registry: TPLA for LUTS</brief_title>
  <official_title>Registry of Transperineal Laser Ablation for Treatment of Lower Urinary Tract Symptoms With Use of the Echolaser® Device: A Multicentre, International Registry to Evaluate the Treatment of LUTS in Terms of Long-term Efficacy, Functional Outcomes and Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
      Rationale: The treatment of lower urinary tract symptoms (LUTS) due to benign prostatic&#xD;
      enlargement in men with transperineal laser ablation (TPLA) may offer advantages in&#xD;
      functional outcomes and safety over current standard therapies. As the technique is&#xD;
      relatively new, indications and outcomes for this treatment are subject of investigation.&#xD;
      However, the technique is already applied outside clinical studies. Clinical information from&#xD;
      these treatments can be useful for future research. The aim of this study is to collect data&#xD;
      on patients treated with transperineal laser ablation of the prostate outside clinical trials&#xD;
      and to provide data on safety and functional outcomes in these patients in order to improve&#xD;
      treatment.&#xD;
&#xD;
      Objective: To assess long-term efficacy of transperineal laser ablation for lower urinary&#xD;
      tract symptoms, to assess functional outcomes, to assess safety, to determine baseline&#xD;
      patient characteristics, to collect information on possible differences between centres&#xD;
      applying treatment of transperineal laser ablation and to explore the optimal treatment&#xD;
      indications and possible limitations.&#xD;
&#xD;
      Study design: This is an international prospective observational study in which data is&#xD;
      recorded of patients who are treated with transperineal laser ablation for lower urinary&#xD;
      tract symptoms.&#xD;
&#xD;
      Study population: Male patients treated with transperineal laser ablation for lower urinary&#xD;
      tract symptoms due to benign prostatic enlargement.&#xD;
&#xD;
      Main study parameters/endpoints: The primary endpoint of this study is long-term efficacy of&#xD;
      transperineal laser ablation for lower urinary tract symptoms measured by the time until&#xD;
      surgical retreatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2029</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2029</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Long-term treatment efficacy measured by the time until surgical retreatment.</measure>
    <time_frame>5 years following TPLA treatment</time_frame>
    <description>The treatment effectiveness is measured by the time until the need for surgical retreatment. This is measured by the time between the TPLA treatment and retreatment indicated due to new micturion problems. The time is expressed in years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Experienced functional efficacy measured by change in International Prostate Symptom Score</measure>
    <time_frame>12 months following TPLA treatment</time_frame>
    <description>The experienced functional efficacy is measured by change in the International Prostate Symptom Score (IPSS). The IPSS is a is a self-administered scale of 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) will be evaluated separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objectified functional efficacy measured by change of maximum flow by uroflowmetry.</measure>
    <time_frame>12 months following TPLA treatment</time_frame>
    <description>Change in maximum urinary flow rate after 12 months compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term treatment efficacy measured by the time until restart of urological medication.</measure>
    <time_frame>5 years following TPLA treatment</time_frame>
    <description>The treatment effectiveness is measured by the time until the need for medical treatment due to new miction symptoms. This is measured by the time between the TPLA treatment and start of medical treatment for LUTS. The time is expressed in years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural safety measuered by the incidence of TPLA procedure related adverse events, reported by the CTCAE v5.0..</measure>
    <time_frame>1 day following TPLA treatment</time_frame>
    <description>Number of intraoperative adverse events using the CTCAE v5.0. Procedural safety is shown when no adverse events of grade 3 or higher.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment safety measured by adverse event incidence at 30 days, reported by the CTCAE v5.0</measure>
    <time_frame>30 days following TPLA treatment</time_frame>
    <description>Number of adverse events using the CTCAE v5.0. Treatment safety is shown when no adverse events of grade 3b or higher are reported at 30 days post-TPLA treatment.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <condition>Benign Prostate Hyperplasia</condition>
  <condition>Benign Prostatic Hypertrophy With Outflow Obstruction</condition>
  <arm_group>
    <arm_group_label>TPLA</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transperineal Laser Ablation</intervention_name>
    <description>Transperineal Laser Ablation of the Prostate</description>
    <arm_group_label>TPLA</arm_group_label>
    <other_name>Echolaser X4</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population comprises those patients presenting with lower urinary tract symptoms&#xD;
        due to benign prostatic enlargement and are planned to undergo transperineal laser ablation&#xD;
        in the participating centres.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Presenting with lower urinary tract symptoms&#xD;
&#xD;
          -  Indication for transperineal laser ablation&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Previous or active treatment for prostate cancer (active surveillance is not seen as&#xD;
             active treatment)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>H Beerlage, Prof.</last_name>
    <phone>+31 20 5664776</phone>
    <email>h.p.beerlage@amc.uva.nl</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Dr. T.M. de Reijke</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Transperineal laser ablation</keyword>
  <keyword>LUTS</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>
    <mesh_term>Hypertrophy</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</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/NCT03776006
org study id: W18_316
nct id: NCT03776006
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rationale: The treatment of lower urinary tract symptoms (LUTS) due to benign prostatic
      enlargement in men with transperineal laser ablation (TPLA) may offer advantages in
      functional outcomes and safety over current standard therapies. As the technique is
      relatively new, indications and outcomes for this treatment are subject of investigation.
      However, the technique is already applied outside clinical studies. Clinical information from
      these treatments can be useful for future research. The aim of this study is to collect data
      on patients treated with transperineal laser ablation of the prostate outside clinical trials
      and to provide data on safety and functional outcomes in these patients in order to improve
      treatment.

      Objective: To assess long-term efficacy of transperineal laser ablation for lower urinary
      tract symptoms, to assess functional outcomes, to assess safety, to determine baseline
      patient characteristics, to collect information on possible differences between centres
      applying treatment of transperineal laser ablation and to explore the optimal treatment
      indications and possible limitations.

      Study design: This is an international prospective observational study in which data is
      recorded of patients who are treated with transperineal laser ablation for lower urinary
      tract symptoms.

      Study population: Male patients treated with transperineal laser ablation for lower urinary
      tract symptoms due to benign prostatic enlargement.

      Main study parameters/endpoints: The primary endpoint of this study is long-term efficacy of
      transperineal laser ablation for lower urinary tract symptoms measured by the time until
      surgical retreatment.
observational model: Cohort
time perspective: Prospective
measure: Long-term treatment efficacy measured by the time until surgical retreatment.
time frame: 5 years following TPLA treatment
description: The treatment effectiveness is measured by the time until the need for surgical retreatment. This is measured by the time between the TPLA treatment and retreatment indicated due to new micturion problems. The time is expressed in years.
measure: Experienced functional efficacy measured by change in International Prostate Symptom Score
time frame: 12 months following TPLA treatment
description: The experienced functional efficacy is measured by change in the International Prostate Symptom Score (IPSS). The IPSS is a is a self-administered scale of 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) will be evaluated separately.
measure: Objectified functional efficacy measured by change of maximum flow by uroflowmetry.
time frame: 12 months following TPLA treatment
description: Change in maximum urinary flow rate after 12 months compared to baseline.
measure: Long-term treatment efficacy measured by the time until restart of urological medication.
time frame: 5 years following TPLA treatment
description: The treatment effectiveness is measured by the time until the need for medical treatment due to new miction symptoms. This is measured by the time between the TPLA treatment and start of medical treatment for LUTS. The time is expressed in years.
measure: Procedural safety measuered by the incidence of TPLA procedure related adverse events, reported by the CTCAE v5.0..
time frame: 1 day following TPLA treatment
description: Number of intraoperative adverse events using the CTCAE v5.0. Procedural safety is shown when no adverse events of grade 3 or higher.
measure: Treatment safety measured by adverse event incidence at 30 days, reported by the CTCAE v5.0
time frame: 30 days following TPLA treatment
description: Number of adverse events using the CTCAE v5.0. Treatment safety is shown when no adverse events of grade 3b or higher are reported at 30 days post-TPLA treatment.
arm group label: TPLA
intervention type: Procedure
intervention name: Transperineal Laser Ablation
description: Transperineal Laser Ablation of the Prostate
arm group label: TPLA
other name: Echolaser X4
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: H Beerlage, Prof.
phone: +31 20 5664776
email: h.p.beerlage@amc.uva.nl
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Dr. T.M. de Reijke
investigator title: Principal Investigator
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Hypertrophy
mesh term: Lower Urinary Tract Symptoms
sharing ipd: Undecided