<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/NCT03808038</url>
  </required_header>
  <id_info>
    <org_study_id>LURN Recall Study</org_study_id>
    <secondary_id>U01DK097780</secondary_id>
    <secondary_id>U01DK097772</secondary_id>
    <secondary_id>U01DK097779</secondary_id>
    <secondary_id>U01DK099932</secondary_id>
    <secondary_id>U01DK100011</secondary_id>
    <secondary_id>U01DK100017</secondary_id>
    <secondary_id>U01DK097776</secondary_id>
    <secondary_id>U01DK099879</secondary_id>
    <nct_id>NCT03808038</nct_id>
  </id_info>
  <brief_title>Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study</brief_title>
  <official_title>Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Protocol 2/Recall Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arbor Research Collaborative for Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Arbor Research Collaborative for Health</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to advance the understanding of people who experience urinary&#xD;
      and bladder problems. The investigators are interested in learning about people's experiences&#xD;
      with urinary symptoms and how these symptoms will be managed. The investigators want to&#xD;
      understand the important differences among people and what factors affect urinary and bladder&#xD;
      problems. After all of the information is collected, the investigators will have a better&#xD;
      understanding of how to improve the care and treatment for people who have urinary and&#xD;
      bladder problems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol is part of an overall effort to create a state-of-the-art resource for&#xD;
      measuring patient-reported health for patients with lower urinary tract dysfunction (LUTD).&#xD;
      The primary purpose of this resource, known as the LURN PRO Battery, is to comprehensively&#xD;
      characterize the self-reported experiences of patients with LUTD for the purpose of enhancing&#xD;
      efforts to characterize and explain important subtypes of patients with LUTD (phenotypes).&#xD;
      Secondary purposes of the LURN PRO Battery, for which additional development work will be&#xD;
      required, include developing better patient-reported endpoints for clinical trials,&#xD;
      monitoring symptoms in the course of clinical care, and screening patients into important&#xD;
      subgroups for purposes of tailored interventions.&#xD;
&#xD;
      Incorporating methods the investigators have used successfully in prior measure validation&#xD;
      work, the investigators propose to conduct a diary study in which patients record their&#xD;
      symptoms at various time points - at the end of each day, or across multiple days. The&#xD;
      investigators also ask them to complete self-report measures with different recall periods&#xD;
      (i.e., 3-day, 7-day, and 30-day recall), and will determine how well each of these correspond&#xD;
      to daily experiences recorded in more frequent assessments (i.e., end-of-day and 3-day&#xD;
      patient bladder diaries). These data will help LURN investigators to determine the most&#xD;
      appropriate reporting period for specific symptoms. This study can also help to identify&#xD;
      causes of differences that exist between shorter and longer recall periods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determine ideal recall period for LUTS symptoms</measure>
    <time_frame>Through study completion - 30 days</time_frame>
    <description>The investigators will administer and analyze the correspondence between patient's average daily recall of their LUTS utilizing seven, daily questionnaires, their weekly recall of self-reported LUTS using a 7-day recall questionnaire, as well as a questionnaire assessing their monthly LUTS recall in order to determine the best recall period to utilize when administering LUTS questionnaires in clinical settings.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">515</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>No Diary Group</arm_group_label>
    <description>Group completed daily questionnaires for four weeks, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diary Start Group</arm_group_label>
    <description>Group completed bladder diaries in week 1, daily questionnaires in week 1, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Daily Start Group</arm_group_label>
    <description>Group completed daily questionnaires in week 1, bladder diaries in week 2, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>None- Observational Study</intervention_name>
    <description>None- Observational Study</description>
    <arm_group_label>Daily Start Group</arm_group_label>
    <arm_group_label>Diary Start Group</arm_group_label>
    <arm_group_label>No Diary Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with LUTS presenting to LURN clinical sites will be screened for participation&#xD;
        based on the inclusion and exclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 18 or older,&#xD;
&#xD;
          2. willing and able to give informed consent,&#xD;
&#xD;
          3. able to speak, read, and understand English,&#xD;
&#xD;
          4. able to reliably complete self-reported questionnaires online at specified times&#xD;
             (i.e., may exclude those who do not keep a regular schedule of sleeping during night&#xD;
             hours), and&#xD;
&#xD;
          5. experienced at least moderate severity and bother from at least 1 of the 7 targeted&#xD;
             symptoms in the past 2 weeks and in the past 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. dementia or other cognitive impairment that would interfere with study participation,&#xD;
&#xD;
          2. known pregnancy or delivery within past 6 months (women only)&#xD;
&#xD;
          3. planned change in medications to treat LUTS in the middle of the study time frame,&#xD;
&#xD;
          4. receiving active treatment for any malignancy (including maintenance medications),&#xD;
&#xD;
          5. received surgery with general or spinal/epidural anesthesia in the past 3 months or&#xD;
             planned surgery during the study time frame&#xD;
&#xD;
          6. lower urinary tract instrumentation (e.g. self-catheterization or cystoscopy) in past&#xD;
             3 months or planned during the study time frame and&#xD;
&#xD;
          7. prostate biopsy in the past 3 months or planned during the study time frame&#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>Kevin P. Weinfurt, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Claire C. Yang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert M. Merion, MD, FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arbor Research Collaborative for Health - DCC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lower Urinary Tract Symptoms</keyword>
  <keyword>Bladder Symptoms</keyword>
  <keyword>Recall</keyword>
  <keyword>Lower Urinary Tract Dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not plan to make IPD available.</ipd_description>
  </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/NCT03808038
org study id: LURN Recall Study
secondary id: U01DK097780
secondary id: U01DK097772
secondary id: U01DK097779
secondary id: U01DK099932
secondary id: U01DK100011
secondary id: U01DK100017
secondary id: U01DK097776
secondary id: U01DK099879
nct id: NCT03808038
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to advance the understanding of people who experience urinary
      and bladder problems. The investigators are interested in learning about people's experiences
      with urinary symptoms and how these symptoms will be managed. The investigators want to
      understand the important differences among people and what factors affect urinary and bladder
      problems. After all of the information is collected, the investigators will have a better
      understanding of how to improve the care and treatment for people who have urinary and
      bladder problems.
This protocol is part of an overall effort to create a state-of-the-art resource for
      measuring patient-reported health for patients with lower urinary tract dysfunction (LUTD).
      The primary purpose of this resource, known as the LURN PRO Battery, is to comprehensively
      characterize the self-reported experiences of patients with LUTD for the purpose of enhancing
      efforts to characterize and explain important subtypes of patients with LUTD (phenotypes).
      Secondary purposes of the LURN PRO Battery, for which additional development work will be
      required, include developing better patient-reported endpoints for clinical trials,
      monitoring symptoms in the course of clinical care, and screening patients into important
      subgroups for purposes of tailored interventions.

      Incorporating methods the investigators have used successfully in prior measure validation
      work, the investigators propose to conduct a diary study in which patients record their
      symptoms at various time points - at the end of each day, or across multiple days. The
      investigators also ask them to complete self-report measures with different recall periods
      (i.e., 3-day, 7-day, and 30-day recall), and will determine how well each of these correspond
      to daily experiences recorded in more frequent assessments (i.e., end-of-day and 3-day
      patient bladder diaries). These data will help LURN investigators to determine the most
      appropriate reporting period for specific symptoms. This study can also help to identify
      causes of differences that exist between shorter and longer recall periods.
observational model: Cohort
time perspective: Cross-Sectional
measure: Determine ideal recall period for LUTS symptoms
time frame: Through study completion - 30 days
description: The investigators will administer and analyze the correspondence between patient's average daily recall of their LUTS utilizing seven, daily questionnaires, their weekly recall of self-reported LUTS using a 7-day recall questionnaire, as well as a questionnaire assessing their monthly LUTS recall in order to determine the best recall period to utilize when administering LUTS questionnaires in clinical settings.
arm group label: No Diary Group
description: Group completed daily questionnaires for four weeks, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study
arm group label: Diary Start Group
description: Group completed bladder diaries in week 1, daily questionnaires in week 1, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study
arm group label: Daily Start Group
description: Group completed daily questionnaires in week 1, bladder diaries in week 2, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study
intervention type: Other
intervention name: None- Observational Study
description: None- Observational Study
arm group label: Daily Start Group
arm group label: Diary Start Group
arm group label: No Diary Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin P. Weinfurt, PhD
role: Study Chair
affiliation: Duke University
last name: Claire C. Yang, MD
role: Study Chair
affiliation: University of Washington
last name: Robert M. Merion, MD, FACS
role: Principal Investigator
affiliation: Arbor Research Collaborative for Health - DCC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lower Urinary Tract Symptoms
sharing ipd: No
ipd description: We do not plan to make IPD available.