<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/NCT02211313</url>
  </required_header>
  <id_info>
    <org_study_id>201205184</org_study_id>
    <nct_id>NCT02211313</nct_id>
  </id_info>
  <brief_title>Evaluation of Ureteral Stents in the Management of Stone Disease</brief_title>
  <official_title>Evaluation of Ureteral Stents in the Management of Stone Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as&#xD;
      treatment of urinary stone disease. Stents are designed to help provide drainage of the&#xD;
      kidney in the setting of an obstructing stone, or postoperative swelling of the ureter.&#xD;
      Though their presence is only temporary, stents are associated with a significant amount of&#xD;
      patient discomfort and bother, which can negatively impact overall satisfaction. Over the&#xD;
      past decades, there have been refinements in stent technology and usage philosophy. Smaller&#xD;
      and softer stents are now available for use in patients, though studies evaluating the&#xD;
      relative benefits have been conflicting. The investigators aim to evaluate the effect of&#xD;
      stent size and composition upon outcomes after the treatment of stone disease, including&#xD;
      patient comfort and satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of further funding.&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 3, 2018</completion_date>
  <primary_completion_date type="Actual">April 3, 2018</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.</measure>
    <time_frame>Baseline, day 7 post stent removal</time_frame>
    <description>The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Urinary Stones</condition>
  <condition>Urinary Tract Stones</condition>
  <arm_group>
    <arm_group_label>Ureteral stent - soft, 6 French</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to soft stent, size 6 French</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ureteral stent - hydrophobic, 6 French</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to hydrophobic stent, size 6 French</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.</intervention_name>
    <description>Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.</description>
    <arm_group_label>Ureteral stent - hydrophobic, 6 French</arm_group_label>
    <arm_group_label>Ureteral stent - soft, 6 French</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Over 18 years of age and willing and able to provide informed consent&#xD;
&#xD;
          2. Patients with current urinary stone disease, undergoing any of the following&#xD;
             procedures:&#xD;
&#xD;
               -  cystoscopy with stent placement&#xD;
&#xD;
               -  ureteroscopy with intracorporeal lithotripsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with compromised urinary tract due to cancer (e.g. bladder tumor, ureteral&#xD;
             obstruction from non-GU malignancy)&#xD;
&#xD;
          2. Patients requiring bilateral surgical stone management procedure&#xD;
&#xD;
          3. Patients with any single stone exceeding 1.5 cm&#xD;
&#xD;
          4. Patients with severe concurrent disease, infection, or co-morbidity that, in the&#xD;
             judgment of the investigator, would render the patient inappropriate for enrollment&#xD;
&#xD;
          5. Any patient who is on anticholinergic medication at baseline&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alana C Desai, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington UniversitySchool of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <results_first_submitted>April 1, 2019</results_first_submitted>
  <results_first_submitted_qc>April 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 21, 2019</results_first_posted>
  <last_update_submitted>May 22, 2019</last_update_submitted>
  <last_update_submitted_qc>May 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Calculi</mesh_term>
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02211313/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ureteral Stent - Soft, 6 French</title>
          <description>Subjects randomized to soft stent, size 6 French&#xD;
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.</description>
        </group>
        <group group_id="P2">
          <title>Ureteral Stent - Hydrophobic, 6 French</title>
          <description>Subjects randomized to hydrophobic stent, size 6 French&#xD;
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Treatment Failure</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Follow up Questionnaires</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ureteral Stent - Soft, 6 French</title>
          <description>Subjects randomized to soft stent, size 6 French&#xD;
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.</description>
        </group>
        <group group_id="B2">
          <title>Ureteral Stent - Hydrophobic, 6 French</title>
          <description>Subjects randomized to hydrophobic stent, size 6 French&#xD;
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.</title>
        <description>The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.</description>
        <time_frame>Baseline, day 7 post stent removal</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ureteral Stent - Soft, 6 French</title>
            <description>Subjects randomized to soft stent, size 6 French&#xD;
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.</description>
          </group>
          <group group_id="O2">
            <title>Ureteral Stent - Hydrophobic, 6 French</title>
            <description>Subjects randomized to hydrophobic stent, size 6 French&#xD;
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.</title>
          <description>The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.</description>
          <units>Scores on a scale 0-10 (Numeric)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre Stent: Pain rating 0-10 (Numeric)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.7"/>
                    <measurement group_id="O2" value="1.5" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>In-Situ: Pain rating 0-10 (Numeric)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="3.5"/>
                    <measurement group_id="O2" value="4.8" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post: Pain rating 0-10 (Numeric)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.1"/>
                    <measurement group_id="O2" value="1.1" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time of the initial stent placement through the completion of the 7 day post stent removal questionnaires. The timeframe in which data was collected for adverse events was up to 27 days.</time_frame>
      <desc>Participation in the study did not pose any risks to the participants beyond what was expected from the standard of care surgical stone management procedure.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ureteral Stent - Soft, 6 French</title>
          <description>Subjects randomized to soft stent, size 6 French&#xD;
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.</description>
        </group>
        <group group_id="E2">
          <title>Ureteral Stent - Hydrophobic, 6 French</title>
          <description>Subjects randomized to hydrophobic stent, size 6 French&#xD;
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Alana Desai, M.D.</name_or_title>
      <organization>Washington University School of Medicine</organization>
      <phone>(314) 362-7581</phone>
      <email>desaia@wustl.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02211313
org study id: 201205184
nct id: NCT02211313
lead sponsor: 
has dmc: No
A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as
      treatment of urinary stone disease. Stents are designed to help provide drainage of the
      kidney in the setting of an obstructing stone, or postoperative swelling of the ureter.
      Though their presence is only temporary, stents are associated with a significant amount of
      patient discomfort and bother, which can negatively impact overall satisfaction. Over the
      past decades, there have been refinements in stent technology and usage philosophy. Smaller
      and softer stents are now available for use in patients, though studies evaluating the
      relative benefits have been conflicting. The investigators aim to evaluate the effect of
      stent size and composition upon outcomes after the treatment of stone disease, including
      patient comfort and satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.
time frame: Baseline, day 7 post stent removal
description: The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.
arm group label: Ureteral stent - soft, 6 French
arm group type: Active Comparator
description: Subjects randomized to soft stent, size 6 French
arm group label: Ureteral stent - hydrophobic, 6 French
arm group type: Active Comparator
description: Subjects randomized to hydrophobic stent, size 6 French
intervention type: Device
intervention name: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.
description: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
arm group label: Ureteral stent - hydrophobic, 6 French
arm group label: Ureteral stent - soft, 6 French
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alana C Desai, M.D.
role: Principal Investigator
affiliation: Washington UniversitySchool of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Calculi
mesh term: Urolithiasis
mesh term: Calculi
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 