<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/NCT03257306</url>
  </required_header>
  <id_info>
    <org_study_id>EMTK 66/1801/2017</org_study_id>
    <nct_id>NCT03257306</nct_id>
  </id_info>
  <brief_title>Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS)</brief_title>
  <acronym>MAGUSS</acronym>
  <official_title>Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kuopio University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Satakunta Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jyväskylä Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Turku University Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aim of this study is to validate our hypothesis that the magnetic ureteral&#xD;
      stents have the same amount of adverse effects as the more commonly used non-magnetic&#xD;
      ureteral stents. If this hypothesis would be confirmed then the usage of magnetic ureteral&#xD;
      stents would be justified for both reducing patient discomfort by way of fewer cystoscopies&#xD;
      and possibly also decreasing the overall expenditures of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many urological procedures involving the kidney and the ureters require a stent replacement&#xD;
      to avoid un-wanted adverse invents caused by the procedure itself. The stenting, however,&#xD;
      predisposes the patient to adverse effects of its own and the application and removal of the&#xD;
      stent is a notable monetary expense. The use of magnetic ureteral stents that can be removed&#xD;
      via catheter instead of requiring an additional cystoscopy for removal would reduce the&#xD;
      discomfort to patients and also possibly decrease the expenditures of the overall treatment.&#xD;
      However, the comparability of standard ureteral stents and the magnetic ureteral stents is&#xD;
      largely unknown due to there being no published research on the subject as of this time. The&#xD;
      specific aim of this study is to validate our hypothesis that the magnetic ureteral stents&#xD;
      have the same amount of adverse effects as the more commonly used non-magnetic ureteral&#xD;
      stents.&#xD;
&#xD;
      The design is as prospective randomized, single-blinded, multi-institutional, non-inferiority&#xD;
      study conducted in Hospital Districts of Southwest Finland, Päijät-Häme, Pohjois-Savo,&#xD;
      Satakunta and Keski-Suomi. Using age and gender stratification, patients are randomised 1:1&#xD;
      fashion into having a magnetic (n=85) or standard ureter stent (n=85). The primary objectives&#xD;
      are the mean differences between the two groups in pain and urinary symptoms scores&#xD;
      determined by the Ureteral Stent Symptom Questionnaire (USSQ) 4 weeks after stent placement.&#xD;
&#xD;
      The patients will be recruited starting from the 4rd quarter of 2018 and ending during the&#xD;
      3rd quarter of 2020. Preliminary analysis of all results will be available in September 2020&#xD;
      and reports are expected to be written during December 2020.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 9, 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>
    <intervention_model_description>Prospective randomized, single-blinded, multi-institutional, non-inferiority study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain score in Ureteral Stent Symptom Questionnaire (USSQ)</measure>
    <time_frame>4 weeks after stent placement and 4 weeks after stent removal</time_frame>
    <description>4 weeks after stent placement. [5] Less than 5 points of difference between the two study groups is considered as clinically insignificant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>General health score in Ureteral Stent Symptom Questionnaire (USSQ)</measure>
    <time_frame>4 weeks after stent placement and 4 weeks after stent removal</time_frame>
    <description>4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual score in Ureteral Stent Symptom Questionnaire (USSQ)</measure>
    <time_frame>4 weeks after stent placement and 4 weeks after stent removal</time_frame>
    <description>4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working performance score in Ureteral Stent Symptom Questionnaire (USSQ)</measure>
    <time_frame>4 weeks after stent placement and 4 weeks after stent removal</time_frame>
    <description>4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary symptom score in Ureteral Stent Symptom Questionnaire (USSQ)</measure>
    <time_frame>4 weeks after stent placement and 4 weeks after stent removal</time_frame>
    <description>4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The discomfort experienced by the patients during stent removal determined in 100mm Visual Analogue Scale (VAS).</measure>
    <time_frame>4 weeks after stent placement</time_frame>
    <description>More than 10mm difference between the two groups is considered as clinically significant.</description>
  </other_outcome>
  <other_outcome>
    <measure>The number of unsuccessful removals of the magnetic stent.</measure>
    <time_frame>4 weeks after stent placement</time_frame>
    <description>Unsuccessful removal using magnet</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Urinary Tract Stone</condition>
  <condition>Kidney Stone</condition>
  <arm_group>
    <arm_group_label>Magnetic double-J ureteric stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Double-J ureteric stent removed using magnet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard double-J ureteric stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Double-J stent removed using cystoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ureteral double-J stent removal using magnet</intervention_name>
    <description>Double-J ureteric stent removed using magnet</description>
    <arm_group_label>Magnetic double-J ureteric stent</arm_group_label>
    <arm_group_label>Standard double-J ureteric stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ureteral double-J stent removal using cystoscopy</intervention_name>
    <description>Double-J ureteric stent removed using cystoscopy</description>
    <arm_group_label>Magnetic double-J ureteric stent</arm_group_label>
    <arm_group_label>Standard double-J ureteric stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Language spoken: Finnish&#xD;
&#xD;
          -  Clinically evaluated need for short term ureter stenting in course of extracorporeal&#xD;
             shockwave lithotripsy-treatment or after pyeloscopy&#xD;
&#xD;
          -  Mental status: Patients must be able to understand the meaning of the study&#xD;
&#xD;
          -  Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved&#xD;
             informed consent documents in the presence of the designated staff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of alpha blockers&#xD;
&#xD;
          -  Patients undergoing emergency ureteroscopy and stenting&#xD;
&#xD;
          -  Patients with a long term ureter stents&#xD;
&#xD;
          -  Any other conditions that might compromise patients safety, based on the clinical&#xD;
             judgment of the responsible urologist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kari T Syvänen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Turku University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kari T Syvänen, MD, PhD</last_name>
    <phone>+3582313000</phone>
    <email>kari.syvanen@tyks.fi</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Otto Ettala, MD, PhD</last_name>
    <phone>+3582313000</phone>
    <email>otto.ettala@tyks.fi</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Keski-Suomi Central Hospital</name>
      <address>
        <city>Jyväskylä</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heikki Seikkula, MD, PhD</last_name>
      <email>heikki.seikkula@ksshp.fi</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Satakunta Central Hospital</name>
      <address>
        <city>Pori</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teemu Joutsi, MD</last_name>
      <email>teemu.joutsi@satshp.fi</email>
    </contact>
    <investigator>
      <last_name>Lauri Reunanen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kari T Syvänen, MD, PhD</last_name>
      <phone>+3582313000</phone>
      <email>kari.syvanen@tyks.fi</email>
    </contact>
    <contact_backup>
      <last_name>Otto Ettala, MD, PhD</last_name>
      <phone>+3582313000</phone>
      <email>otto.ettala@tyks.fi</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turku University Hospital</investigator_affiliation>
    <investigator_full_name>Kari Syvanen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Urinary tract stone</keyword>
  <keyword>ureter double-J stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Urinary Calculi</mesh_term>
  </condition_browse>
  <!-- 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/NCT03257306
org study id: EMTK 66/1801/2017
nct id: NCT03257306
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The specific aim of this study is to validate our hypothesis that the magnetic ureteral
      stents have the same amount of adverse effects as the more commonly used non-magnetic
      ureteral stents. If this hypothesis would be confirmed then the usage of magnetic ureteral
      stents would be justified for both reducing patient discomfort by way of fewer cystoscopies
      and possibly also decreasing the overall expenditures of treatment.
Many urological procedures involving the kidney and the ureters require a stent replacement
      to avoid un-wanted adverse invents caused by the procedure itself. The stenting, however,
      predisposes the patient to adverse effects of its own and the application and removal of the
      stent is a notable monetary expense. The use of magnetic ureteral stents that can be removed
      via catheter instead of requiring an additional cystoscopy for removal would reduce the
      discomfort to patients and also possibly decrease the expenditures of the overall treatment.
      However, the comparability of standard ureteral stents and the magnetic ureteral stents is
      largely unknown due to there being no published research on the subject as of this time. The
      specific aim of this study is to validate our hypothesis that the magnetic ureteral stents
      have the same amount of adverse effects as the more commonly used non-magnetic ureteral
      stents.

      The design is as prospective randomized, single-blinded, multi-institutional, non-inferiority
      study conducted in Hospital Districts of Southwest Finland, Päijät-Häme, Pohjois-Savo,
      Satakunta and Keski-Suomi. Using age and gender stratification, patients are randomised 1:1
      fashion into having a magnetic (n=85) or standard ureter stent (n=85). The primary objectives
      are the mean differences between the two groups in pain and urinary symptoms scores
      determined by the Ureteral Stent Symptom Questionnaire (USSQ) 4 weeks after stent placement.

      The patients will be recruited starting from the 4rd quarter of 2018 and ending during the
      3rd quarter of 2020. Preliminary analysis of all results will be available in September 2020
      and reports are expected to be written during December 2020.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective randomized, single-blinded, multi-institutional, non-inferiority study
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Pain score in Ureteral Stent Symptom Questionnaire (USSQ)
time frame: 4 weeks after stent placement and 4 weeks after stent removal
description: 4 weeks after stent placement. [5] Less than 5 points of difference between the two study groups is considered as clinically insignificant.
measure: General health score in Ureteral Stent Symptom Questionnaire (USSQ)
time frame: 4 weeks after stent placement and 4 weeks after stent removal
description: 4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.
measure: Sexual score in Ureteral Stent Symptom Questionnaire (USSQ)
time frame: 4 weeks after stent placement and 4 weeks after stent removal
description: 4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.
measure: Working performance score in Ureteral Stent Symptom Questionnaire (USSQ)
time frame: 4 weeks after stent placement and 4 weeks after stent removal
description: 4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.
measure: Urinary symptom score in Ureteral Stent Symptom Questionnaire (USSQ)
time frame: 4 weeks after stent placement and 4 weeks after stent removal
description: 4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.
measure: The discomfort experienced by the patients during stent removal determined in 100mm Visual Analogue Scale (VAS).
time frame: 4 weeks after stent placement
description: More than 10mm difference between the two groups is considered as clinically significant.
measure: The number of unsuccessful removals of the magnetic stent.
time frame: 4 weeks after stent placement
description: Unsuccessful removal using magnet
arm group label: Magnetic double-J ureteric stent
arm group type: Active Comparator
description: Double-J ureteric stent removed using magnet
arm group label: Standard double-J ureteric stent
arm group type: Active Comparator
description: Double-J stent removed using cystoscopy
intervention type: Procedure
intervention name: ureteral double-J stent removal using magnet
description: Double-J ureteric stent removed using magnet
arm group label: Magnetic double-J ureteric stent
arm group label: Standard double-J ureteric stent
intervention type: Procedure
intervention name: ureteral double-J stent removal using cystoscopy
description: Double-J ureteric stent removed using cystoscopy
arm group label: Magnetic double-J ureteric stent
arm group label: Standard double-J ureteric stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Kari T Syvänen, MD, PhD
role: Principal Investigator
affiliation: Turku University Hospital
last name: Kari T Syvänen, MD, PhD
phone: +3582313000
email: kari.syvanen@tyks.fi
last name: Otto Ettala, MD, PhD
phone: +3582313000
email: otto.ettala@tyks.fi
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Turku University Hospital
investigator full name: Kari Syvanen
investigator title: Principal Investigator
mesh term: Kidney Calculi
mesh term: Urinary Calculi