<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/NCT03750656</url>
  </required_header>
  <id_info>
    <org_study_id>HSC 142994</org_study_id>
    <nct_id>NCT03750656</nct_id>
  </id_info>
  <brief_title>Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation</brief_title>
  <acronym>HyTa Stent</acronym>
  <official_title>Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin&#xD;
      monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J&#xD;
      ureteral stents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ureteral stents are routinely used in a variety of urologic conditions. Unfortunately,&#xD;
      indwelling ureteral stents commonly cause significant pain and discomfort due to irritation&#xD;
      to the urinary system. Many studies have looked at methods to reduce these uncomfortable&#xD;
      symptoms ranging from altering stent designs to pharmacologic therapies attempting to&#xD;
      alleviate stent-discomfort. However, stent-related discomfort continues to be an issue and is&#xD;
      often the cause of their removal earlier than planned. While the efficacy of certain alpha&#xD;
      blockers and anticholinergics in treating stent-related symptoms have been studied, the data&#xD;
      for the use of hyoscyamine in this setting is lacking. A literature search yielded no studies&#xD;
      evaluating the use of hyoscyamine in this setting to date. The investigators hypothesize that&#xD;
      hyoscyamine (brand name Levsin) is equivalent to tamsulosin in treating lower urinary tract&#xD;
      symptoms in patients with indwelling double-J ureteral stents due to its anticholinergic&#xD;
      properties. Furthermore, the investigators hypothesize that patients in the hyoscyamine arm&#xD;
      will not require additional pain medications (e.g. Pyridium, narcotics) to help control&#xD;
      stent-related discomfort compared to the tamsulosin arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not accruing patients quickly enough&#xD;
  </why_stopped>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Randomized open-blind clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ureteral Stent Symptom Questionnaire Score</measure>
    <time_frame>Three Years</time_frame>
    <description>To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated Ureteral Stent Symptom Questionnaire (USSQ).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Additional Medication Needed</measure>
    <time_frame>Three Years</time_frame>
    <description>To determine if there is a difference between the amount of additional medications needed to treat stent related discomfort between patients receiving hyoscyamine versus those that receive tamsulosin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors that Determine if Additional Medication Needed</measure>
    <time_frame>Three Years</time_frame>
    <description>To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>Hyoscyamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tamsulosin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.4 mg tab orally daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyoscyamine</intervention_name>
    <description>Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent</description>
    <arm_group_label>Hyoscyamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin</intervention_name>
    <description>Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent</description>
    <arm_group_label>Tamsulosin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be 18 years of age or older&#xD;
&#xD;
          -  Patient must require placement of a ureteral stent(s), per standard of care, following&#xD;
             routine urological procedures including, but not limited to, ureteroscopy, stone&#xD;
             extraction, or management of upper tract transitional cell carcinoma&#xD;
&#xD;
          -  Patient must agree to abstain from other clinical studies during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years of age&#xD;
&#xD;
          -  Patients with chronic or pre-existing indwelling stents&#xD;
&#xD;
          -  Patients currently receiving anticholinergic or alpha blocker therapy&#xD;
&#xD;
          -  Patients with chronic opioid or analgesic usage&#xD;
&#xD;
          -  Patients with chronic pain syndrome or symptomatic benign prostatic hyperplasia&#xD;
&#xD;
          -  Patients with an active untreated urinary tract infection&#xD;
&#xD;
          -  Patients who are currently pregnant or nursing&#xD;
&#xD;
          -  Patients with allergies or contraindication to either tamsulosin or hyoscyamine&#xD;
&#xD;
          -  Patients on active chemotherapy&#xD;
&#xD;
          -  Patients currently receiving other investigational therapy&#xD;
&#xD;
          -  Patients who are unable to sign consent/answer questionnaire due to compromised mental&#xD;
             capacity or language barrier (the questionnaire is not validated in other languages)&#xD;
&#xD;
          -  Patients who have a stent placed emergently for an obstructing stone or septic stone&#xD;
             without immediate stone removal,&#xD;
&#xD;
          -  Any stents placed that will stay in for longer than 2 weeks&#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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 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>David Duchene, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyoscyamine</mesh_term>
    <mesh_term>Tamsulosin</mesh_term>
  </intervention_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/NCT03750656
org study id: HSC 142994
nct id: NCT03750656
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin
      monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J
      ureteral stents.
Ureteral stents are routinely used in a variety of urologic conditions. Unfortunately,
      indwelling ureteral stents commonly cause significant pain and discomfort due to irritation
      to the urinary system. Many studies have looked at methods to reduce these uncomfortable
      symptoms ranging from altering stent designs to pharmacologic therapies attempting to
      alleviate stent-discomfort. However, stent-related discomfort continues to be an issue and is
      often the cause of their removal earlier than planned. While the efficacy of certain alpha
      blockers and anticholinergics in treating stent-related symptoms have been studied, the data
      for the use of hyoscyamine in this setting is lacking. A literature search yielded no studies
      evaluating the use of hyoscyamine in this setting to date. The investigators hypothesize that
      hyoscyamine (brand name Levsin) is equivalent to tamsulosin in treating lower urinary tract
      symptoms in patients with indwelling double-J ureteral stents due to its anticholinergic
      properties. Furthermore, the investigators hypothesize that patients in the hyoscyamine arm
      will not require additional pain medications (e.g. Pyridium, narcotics) to help control
      stent-related discomfort compared to the tamsulosin arm.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized open-blind clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Ureteral Stent Symptom Questionnaire Score
time frame: Three Years
description: To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated Ureteral Stent Symptom Questionnaire (USSQ).
measure: Additional Medication Needed
time frame: Three Years
description: To determine if there is a difference between the amount of additional medications needed to treat stent related discomfort between patients receiving hyoscyamine versus those that receive tamsulosin
measure: Factors that Determine if Additional Medication Needed
time frame: Three Years
description: To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort
arm group label: Hyoscyamine
arm group type: Active Comparator
description: Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort
arm group label: Tamsulosin
arm group type: Active Comparator
description: 0.4 mg tab orally daily
intervention type: Drug
intervention name: Hyoscyamine
description: Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent
arm group label: Hyoscyamine
intervention type: Drug
intervention name: Tamsulosin
description: Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent
arm group label: Tamsulosin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: David Duchene, MD
investigator title: Associate Professor
mesh term: Lower Urinary Tract Symptoms
mesh term: Hyoscyamine
mesh term: Tamsulosin
sharing ipd: No