<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/NCT03768765</url>
  </required_header>
  <id_info>
    <org_study_id>143049</org_study_id>
    <nct_id>NCT03768765</nct_id>
  </id_info>
  <brief_title>Duration of Medication Therapy and Outcomes After Holmium Laser Prostate Surgery for Patients With Benign Prostatic Hyperplasia (BPH)</brief_title>
  <official_title>Duration of Medication Therapy and Outcomes After Holmium Laser Prostate Surgery for Patients With Benign Prostatic Hyperplasia (BPH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      To determine if the prior prolonged use of medication, as a treatment for benign prostatic&#xD;
      hyperplasia, reduces the efficacy of Holmium laser enucleation of the prostate (HoLEP) for&#xD;
      patients with benign prostatic hyperplasia (BPH).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experience from clinic has suggested that men who receive medication for long periods of&#xD;
      time, defined as over a year for study purposes, have a poorer response to surgical treatment&#xD;
      for benign prostatic hyperplasia (BPH). It has previously been demonstrated that medication&#xD;
      use does not alter the perioperative outcomes after HoLEP; however, to our knowledge, no&#xD;
      study to date has investigated holmium laser prostate surgery outcomes associated with the&#xD;
      duration of pre-operative medication therapy.&#xD;
&#xD;
      Some of the more common medications for BPH are alpha-1 blockers and 5-alpha-reductase&#xD;
      inhibitors. A five-year study of patients showed that treatment failure, defined as need for&#xD;
      surgery or conversion to other medication, was observed in 18.8% of patients who were&#xD;
      prescribed tamsulosin, an alpha-1 blocker, for BPH. The study further suggested that&#xD;
      treatment with this class of medication may not be appropriate long-term for those patients&#xD;
      with a large prostate volume and/or a large post-void residual volume. Similar results have&#xD;
      been demonstrated with 5-alpha-reductase inhibitors, with more than 30% of men not responding&#xD;
      to its therapeutic effects.&#xD;
&#xD;
      The progression of BPH symptoms is complex and the result of multiple pathways such as&#xD;
      androgen receptor signaling, proinflammatory cytokines, and growth factor signals, all of&#xD;
      which can be affected by medication. 5-alpha-reductase inhibitors work by limiting the&#xD;
      conversion of testosterone to dihydrotestosterone. An overabundance of dihydrotestosterone&#xD;
      can affect the regulation of cell cycle, cell growth, and differentiation in the prostate,&#xD;
      leading to BPH. Alpha-1 blockers work by mediating prostate smooth-muscle relaxation though&#xD;
      it is unclear if this specific action is the reason for the relief of BPH symptoms.&#xD;
      Considering the aforementioned pathways, the goal of this clinical trial is to investigate if&#xD;
      a prolonged period of medication is associated with the effectiveness of holmium laser&#xD;
      surgery. By grouping patients based on medication treatment time, the goal is to determine if&#xD;
      their responses are different and clinically significant, in order to better inform standard&#xD;
      of care practices for those with BPH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Bladder Function</measure>
    <time_frame>Six Months</time_frame>
    <description>The primary objective is to determine if patients who undergo holmium laser surgery prior to being placed on long term medication for benign prostatic hyperplasia (BPH) have a greater improvement in their bladder function, as measured by urodynamics, when compared to patients who undergo holmium laser surgery after being placed on long term medication for BPH.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Six Months</time_frame>
    <description>The secondary objectives are to determine if patients who undergo holmium laser surgery prior to long term medication for benign prostatic hyperplasia (BPH) have a greater improvement in their quality of life, as measured by questionnaires, when compared to patients who under holmium laser surgery after having received long term medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Emptying</measure>
    <time_frame>Six Months</time_frame>
    <description>The secondary objectives are to determine if patients who undergo holmium laser surgery prior to long term medication for benign prostatic hyperplasia have great improvement in complete emptying of their bladder, as measured by post void residual volume (PVR), when compared to patients who under holmium laser surgery after having received long term medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower Urinary Tract Symptoms</measure>
    <time_frame>Six Months</time_frame>
    <description>The secondary objectives are to determine if patients who undergo holmium laser surgery prior to long term medication for benign prostatic hyperplasia have great improvement in regards to their lower urinary tract symptoms, as measured by the American Urology Association (AUA) symptom score, when compared to patients who under holmium laser surgery after having received long term medication. The AUA symptom score is a measure of lower urinary tract symptoms and is scored on a scale of 0-25, with a score in the range of 0-8 indicating mild symptoms, 9-19 indicating moderate symptoms, and a score in 20-35 range indicating severe symptoms.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Long Term Medication Usage</arm_group_label>
    <description>Patients who have been on medication for over a year for benign prostatic hyperplasia (BPH)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short Term Medication Usage</arm_group_label>
    <description>Patients who have been on medication for under a year for benign prostatic hyperplasia (BPH)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Holmium Laser Prostate Surgery</intervention_name>
    <description>Patients will undergo standard of care holmium laser prostate surgery</description>
    <arm_group_label>Long Term Medication Usage</arm_group_label>
    <arm_group_label>Short Term Medication Usage</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will present to clinic for treatment of BPH&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must be 18 years of age or older&#xD;
&#xD;
          2. Patients must present to clinic with a diagnosis of benign prostatic hyperplasia with&#xD;
             lower urinary tract symptoms&#xD;
&#xD;
          3. Patients must be scheduled to undergo a holmium laser prostate surgery (enucleation or&#xD;
             ablation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are under 18 years of age are not eligible.&#xD;
&#xD;
          2. Patients who have a diagnosis of bladder cancer are not eligible.&#xD;
&#xD;
          3. Patient who have a diagnosis of prostate cancer are not eligible.&#xD;
&#xD;
          4. Patients with an elevated prostate-specific antigen (PSA) suggesting prostate cancer&#xD;
             are not eligible unless patient has prior negative prostate biopsy.&#xD;
&#xD;
          5. Patients who have acute prostatitis, a prostate abscess, or neurogenic bladder are not&#xD;
             eligible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Kansas Health System</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandra Dahlgren</last_name>
      <phone>913-574-0847</phone>
      <email>adahlgren@kumc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>September 22, 2020</last_update_submitted>
  <last_update_submitted_qc>September 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Kerri Thurmon</investigator_full_name>
    <investigator_title>Assistant Professor</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>
  </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/NCT03768765
org study id: 143049
nct id: NCT03768765
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine if the prior prolonged use of medication, as a treatment for benign prostatic
      hyperplasia, reduces the efficacy of Holmium laser enucleation of the prostate (HoLEP) for
      patients with benign prostatic hyperplasia (BPH).
Experience from clinic has suggested that men who receive medication for long periods of
      time, defined as over a year for study purposes, have a poorer response to surgical treatment
      for benign prostatic hyperplasia (BPH). It has previously been demonstrated that medication
      use does not alter the perioperative outcomes after HoLEP; however, to our knowledge, no
      study to date has investigated holmium laser prostate surgery outcomes associated with the
      duration of pre-operative medication therapy.

      Some of the more common medications for BPH are alpha-1 blockers and 5-alpha-reductase
      inhibitors. A five-year study of patients showed that treatment failure, defined as need for
      surgery or conversion to other medication, was observed in 18.8% of patients who were
      prescribed tamsulosin, an alpha-1 blocker, for BPH. The study further suggested that
      treatment with this class of medication may not be appropriate long-term for those patients
      with a large prostate volume and/or a large post-void residual volume. Similar results have
      been demonstrated with 5-alpha-reductase inhibitors, with more than 30% of men not responding
      to its therapeutic effects.

      The progression of BPH symptoms is complex and the result of multiple pathways such as
      androgen receptor signaling, proinflammatory cytokines, and growth factor signals, all of
      which can be affected by medication. 5-alpha-reductase inhibitors work by limiting the
      conversion of testosterone to dihydrotestosterone. An overabundance of dihydrotestosterone
      can affect the regulation of cell cycle, cell growth, and differentiation in the prostate,
      leading to BPH. Alpha-1 blockers work by mediating prostate smooth-muscle relaxation though
      it is unclear if this specific action is the reason for the relief of BPH symptoms.
      Considering the aforementioned pathways, the goal of this clinical trial is to investigate if
      a prolonged period of medication is associated with the effectiveness of holmium laser
      surgery. By grouping patients based on medication treatment time, the goal is to determine if
      their responses are different and clinically significant, in order to better inform standard
      of care practices for those with BPH.
observational model: Cohort
time perspective: Prospective
measure: Bladder Function
time frame: Six Months
description: The primary objective is to determine if patients who undergo holmium laser surgery prior to being placed on long term medication for benign prostatic hyperplasia (BPH) have a greater improvement in their bladder function, as measured by urodynamics, when compared to patients who undergo holmium laser surgery after being placed on long term medication for BPH.
measure: Quality of Life
time frame: Six Months
description: The secondary objectives are to determine if patients who undergo holmium laser surgery prior to long term medication for benign prostatic hyperplasia (BPH) have a greater improvement in their quality of life, as measured by questionnaires, when compared to patients who under holmium laser surgery after having received long term medication.
measure: Complete Emptying
time frame: Six Months
description: The secondary objectives are to determine if patients who undergo holmium laser surgery prior to long term medication for benign prostatic hyperplasia have great improvement in complete emptying of their bladder, as measured by post void residual volume (PVR), when compared to patients who under holmium laser surgery after having received long term medication.
measure: Lower Urinary Tract Symptoms
time frame: Six Months
description: The secondary objectives are to determine if patients who undergo holmium laser surgery prior to long term medication for benign prostatic hyperplasia have great improvement in regards to their lower urinary tract symptoms, as measured by the American Urology Association (AUA) symptom score, when compared to patients who under holmium laser surgery after having received long term medication. The AUA symptom score is a measure of lower urinary tract symptoms and is scored on a scale of 0-25, with a score in the range of 0-8 indicating mild symptoms, 9-19 indicating moderate symptoms, and a score in 20-35 range indicating severe symptoms.
arm group label: Long Term Medication Usage
description: Patients who have been on medication for over a year for benign prostatic hyperplasia (BPH)
arm group label: Short Term Medication Usage
description: Patients who have been on medication for under a year for benign prostatic hyperplasia (BPH)
intervention type: Procedure
intervention name: Holmium Laser Prostate Surgery
description: Patients will undergo standard of care holmium laser prostate surgery
arm group label: Long Term Medication Usage
arm group label: Short Term Medication Usage
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Kerri Thurmon
investigator title: Assistant Professor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
sharing ipd: No