<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/NCT02188108</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0062</org_study_id>
    <secondary_id>UW QOL</secondary_id>
    <secondary_id>A539998</secondary_id>
    <secondary_id>SMPH\VOLUNTEER STAFF\UROLOGY</secondary_id>
    <secondary_id>Protocol Version 1/19/2018</secondary_id>
    <nct_id>NCT02188108</nct_id>
  </id_info>
  <brief_title>Validation of the Wisconsin Stone-QOL</brief_title>
  <official_title>Validation of the Wisconsin Stone-QOL, a Quality of Life Survey for Kidney Stone Formers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dartmouth College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall purpose of this study is to evaluate criterion-related validity of a&#xD;
      newly-developed disease-specific instrument to assess the health-related quality of life&#xD;
      (HRQOL) of patients who have had kidney stones. Specific aims of this study are:&#xD;
&#xD;
        1. Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin&#xD;
           Stone-QOL by answering the question, &quot;Is the Wisconsin Stone-QOL useful for assessing&#xD;
           the HRQOL of patients who form kidney stones from a broad region of North America?&quot;&#xD;
&#xD;
        2. Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients&#xD;
           related to stone interventions and other disease-specific outcomes by answering the&#xD;
           question, &quot;Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes&#xD;
           within individuals?&quot;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Wisconsin Stone-QOL was developed as the only known HRQOL instrument designed&#xD;
      specifically for patients with kidney stones. Its development has been published. Internal&#xD;
      and other validity tests on the instrument have been conducted and reported. Further validity&#xD;
      testing of the instrument is needed to confirm its broader utility in the context of surgical&#xD;
      and medical management of patients with kidney stones.&#xD;
&#xD;
      Upon enrollment at each site, patients will be asked to complete a medical history form and&#xD;
      the Wisconsin Stone-QOL. To supplement the information provided in the medical history forms,&#xD;
      patients' medical records will be reviewed in order to collect and enter approved data into a&#xD;
      spreadsheet. Further patient interventions include completion of the Wisconsin Stone-QOL at 3&#xD;
      months, 12 months, 24 months, and 36 months post-enrollment. These post-enrollment surveys&#xD;
      will usually be mailed to patients to the addresses they provide. Alternatively, patients may&#xD;
      be provided the surveys at a urology encounter if it falls on or near the intervention time&#xD;
      points. At each time point, patients' medical records will also be searched to document any&#xD;
      changes in the data entered at enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients' self-reported health-related quality of life (HRQOL)</measure>
    <time_frame>Enrollment</time_frame>
    <description>Change in HRQOL from baseline to follow-up time points will be assessed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients' self-reported quality of life</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Patients' self-reported quality of life</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Patients' self-reported quality of life</measure>
    <time_frame>24 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Patients' self-reported quality of life</measure>
    <time_frame>36 months</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3299</enrollment>
  <condition>Urolithiasis</condition>
  <condition>Nephrolithiasis</condition>
  <condition>Kidney Stones</condition>
  <arm_group>
    <arm_group_label>Survey</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wisconsin Stone-QOL survey. Patients with kidney stones or a history thereof will complete a kidney stone-specific health-related survey at enrollment and post-enrollment at 3 months, 12 months, 24 months, and 36 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wisconsin Stone-QOL survey</intervention_name>
    <description>Patients will complete a health-related quality of life survey at multiple time points at enrollment and at multiple time points thereafter.</description>
    <arm_group_label>Survey</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of kidney stones, either in the past or currently&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  No previous or current diagnosis of kidney stones&#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>Kristina L Penniston, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin Department of Urology, School of Medicine &amp; Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Y Nakada, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin Department of Urology, School of Medicine &amp; Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin-Madison Department of Urology, School of Medicine &amp; Public Heatlh</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705-2281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Penniston KL, Nakada SY. Health related quality of life differs between male and female stone formers. J Urol. 2007 Dec;178(6):2435-40; discussion 2440. doi: 10.1016/j.juro.2007.08.009. Epub 2007 Oct 15.</citation>
    <PMID>17937947</PMID>
  </reference>
  <reference>
    <citation>Penniston KL, Nakada SY. Development of an instrument to assess the health related quality of life of kidney stone formers. J Urol. 2013 Mar;189(3):921-30. doi: 10.1016/j.juro.2012.08.247. Epub 2012 Sep 24.</citation>
    <PMID>23017521</PMID>
  </reference>
  <reference>
    <citation>Ahmad TR, Tzou DT, Usawachintachit M, Reliford-Titus S, Wu C, Goodman J, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Chew BH, Bird VG, Pais VM Jr, Streeper NM, Sur RL, Nakada SY, Penniston KL, Chi T. Low Income and Nonwhite Race are Strongly Associated with Worse Quality of Life in Patients with Nephrolithiasis. J Urol. 2019 Jul;202(1):119-124. doi: 10.1097/JU.0000000000000233. Epub 2019 Jun 7.</citation>
    <PMID>30865567</PMID>
  </reference>
  <reference>
    <citation>Raffin EP, Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Bird VG, Chew BH, Sivalingam S, Sur RL, Nakada SY, Pais VM Jr. The Effect of Thiazide and Potassium Citrate Use on the Health Related Quality of Life of Patients with Urolithiasis. J Urol. 2018 Dec;200(6):1290-1294. doi: 10.1016/j.juro.2018.06.023. Epub 2018 Jun 18.</citation>
    <PMID>29913138</PMID>
  </reference>
  <reference>
    <citation>Stern KL, Gao T, Antonelli JA, Viprakasit DP, Averch TD, Chi T, Chew BH, Bird VG, Pais VM Jr, Streeper NM, Sur RL, Nakada SY, Penniston KL, Sivalingam S. Association of Patient Age and Gender with Kidney Stone Related Quality of Life. J Urol. 2019 Aug;202(2):309-313. doi: 10.1097/JU.0000000000000291. Epub 2019 Jul 8.</citation>
    <PMID>31026215</PMID>
  </reference>
  <reference>
    <citation>Atalay HA, Ulker V, Canat L, Ozer M, Can O, Penniston KL. Validation of the Turkish version of the Wisconsin stone-quality of life questionnaire. Turk J Urol. 2018 Mar 16;45(2):118-123. doi: 10.5152/tud.2018.35305. Print 2019 Mar.</citation>
    <PMID>29799402</PMID>
  </reference>
  <reference>
    <citation>Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Sur RL, Pais VM Jr, Chew BH, Bird VG, Nakada SY. Validation and Reliability of the Wisconsin Stone Quality of Life Questionnaire. J Urol. 2017 May;197(5):1280-1288. doi: 10.1016/j.juro.2016.11.097. Epub 2016 Nov 23.</citation>
    <PMID>27889419</PMID>
  </reference>
  <reference>
    <citation>Streeper NM, Wertheim ML, Nakada SY, Penniston KL. Cystine Stone Formers Have Impaired Health-Related Quality of Life Compared with Noncystine Stone Formers: A Case-Referent Study Piloting the Wisconsin Stone Quality of Life Questionnaire Among Patients with Cystine Stones. J Endourol. 2017 Apr;31(S1):S48-S53. doi: 10.1089/end.2016.0564. Epub 2016 Nov 8.</citation>
    <PMID>27717296</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>quality of life</keyword>
  <keyword>QOL</keyword>
  <keyword>urolithiasis</keyword>
  <keyword>nephrolithiasis</keyword>
  <keyword>kidney stones</keyword>
  <keyword>patient-reported outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Urinary Calculi</mesh_term>
    <mesh_term>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/NCT02188108
org study id: 2014-0062
secondary id: UW QOL
secondary id: A539998
secondary id: SMPH\VOLUNTEER STAFF\UROLOGY
secondary id: Protocol Version 1/19/2018
nct id: NCT02188108
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The overall purpose of this study is to evaluate criterion-related validity of a
      newly-developed disease-specific instrument to assess the health-related quality of life
      (HRQOL) of patients who have had kidney stones. Specific aims of this study are:

        1. Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin
           Stone-QOL by answering the question, "Is the Wisconsin Stone-QOL useful for assessing
           the HRQOL of patients who form kidney stones from a broad region of North America?"

        2. Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients
           related to stone interventions and other disease-specific outcomes by answering the
           question, "Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes
           within individuals?"
The Wisconsin Stone-QOL was developed as the only known HRQOL instrument designed
      specifically for patients with kidney stones. Its development has been published. Internal
      and other validity tests on the instrument have been conducted and reported. Further validity
      testing of the instrument is needed to confirm its broader utility in the context of surgical
      and medical management of patients with kidney stones.

      Upon enrollment at each site, patients will be asked to complete a medical history form and
      the Wisconsin Stone-QOL. To supplement the information provided in the medical history forms,
      patients' medical records will be reviewed in order to collect and enter approved data into a
      spreadsheet. Further patient interventions include completion of the Wisconsin Stone-QOL at 3
      months, 12 months, 24 months, and 36 months post-enrollment. These post-enrollment surveys
      will usually be mailed to patients to the addresses they provide. Alternatively, patients may
      be provided the surveys at a urology encounter if it falls on or near the intervention time
      points. At each time point, patients' medical records will also be searched to document any
      changes in the data entered at enrollment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Patients' self-reported health-related quality of life (HRQOL)
time frame: Enrollment
description: Change in HRQOL from baseline to follow-up time points will be assessed
measure: Patients' self-reported quality of life
time frame: 3 months
measure: Patients' self-reported quality of life
time frame: 12 months
measure: Patients' self-reported quality of life
time frame: 24 months
measure: Patients' self-reported quality of life
time frame: 36 months
arm group label: Survey
arm group type: Experimental
description: Wisconsin Stone-QOL survey. Patients with kidney stones or a history thereof will complete a kidney stone-specific health-related survey at enrollment and post-enrollment at 3 months, 12 months, 24 months, and 36 months.
intervention type: Other
intervention name: Wisconsin Stone-QOL survey
description: Patients will complete a health-related quality of life survey at multiple time points at enrollment and at multiple time points thereafter.
arm group label: Survey
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kristina L Penniston, PhD
role: Principal Investigator
affiliation: University of Wisconsin Department of Urology, School of Medicine & Public Health
last name: Stephen Y Nakada, MD
role: Principal Investigator
affiliation: University of Wisconsin Department of Urology, School of Medicine & Public Health
facility: 
country: United States
citation: Penniston KL, Nakada SY. Health related quality of life differs between male and female stone formers. J Urol. 2007 Dec;178(6):2435-40; discussion 2440. doi: 10.1016/j.juro.2007.08.009. Epub 2007 Oct 15.
PMID: 17937947
citation: Penniston KL, Nakada SY. Development of an instrument to assess the health related quality of life of kidney stone formers. J Urol. 2013 Mar;189(3):921-30. doi: 10.1016/j.juro.2012.08.247. Epub 2012 Sep 24.
PMID: 23017521
citation: Ahmad TR, Tzou DT, Usawachintachit M, Reliford-Titus S, Wu C, Goodman J, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Chew BH, Bird VG, Pais VM Jr, Streeper NM, Sur RL, Nakada SY, Penniston KL, Chi T. Low Income and Nonwhite Race are Strongly Associated with Worse Quality of Life in Patients with Nephrolithiasis. J Urol. 2019 Jul;202(1):119-124. doi: 10.1097/JU.0000000000000233. Epub 2019 Jun 7.
PMID: 30865567
citation: Raffin EP, Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Bird VG, Chew BH, Sivalingam S, Sur RL, Nakada SY, Pais VM Jr. The Effect of Thiazide and Potassium Citrate Use on the Health Related Quality of Life of Patients with Urolithiasis. J Urol. 2018 Dec;200(6):1290-1294. doi: 10.1016/j.juro.2018.06.023. Epub 2018 Jun 18.
PMID: 29913138
citation: Stern KL, Gao T, Antonelli JA, Viprakasit DP, Averch TD, Chi T, Chew BH, Bird VG, Pais VM Jr, Streeper NM, Sur RL, Nakada SY, Penniston KL, Sivalingam S. Association of Patient Age and Gender with Kidney Stone Related Quality of Life. J Urol. 2019 Aug;202(2):309-313. doi: 10.1097/JU.0000000000000291. Epub 2019 Jul 8.
PMID: 31026215
citation: Atalay HA, Ulker V, Canat L, Ozer M, Can O, Penniston KL. Validation of the Turkish version of the Wisconsin stone-quality of life questionnaire. Turk J Urol. 2018 Mar 16;45(2):118-123. doi: 10.5152/tud.2018.35305. Print 2019 Mar.
PMID: 29799402
citation: Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Sur RL, Pais VM Jr, Chew BH, Bird VG, Nakada SY. Validation and Reliability of the Wisconsin Stone Quality of Life Questionnaire. J Urol. 2017 May;197(5):1280-1288. doi: 10.1016/j.juro.2016.11.097. Epub 2016 Nov 23.
PMID: 27889419
citation: Streeper NM, Wertheim ML, Nakada SY, Penniston KL. Cystine Stone Formers Have Impaired Health-Related Quality of Life Compared with Noncystine Stone Formers: A Case-Referent Study Piloting the Wisconsin Stone Quality of Life Questionnaire Among Patients with Cystine Stones. J Endourol. 2017 Apr;31(S1):S48-S53. doi: 10.1089/end.2016.0564. Epub 2016 Nov 8.
PMID: 27717296
responsible party type: Sponsor
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Urolithiasis
mesh term: Urinary Calculi
mesh term: Calculi