<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/NCT02206958</url>
  </required_header>
  <id_info>
    <org_study_id>1112S07944</org_study_id>
    <nct_id>NCT02206958</nct_id>
  </id_info>
  <brief_title>Defeating Urinary Incontinence With Exercise Training (DUET) Feasibility Study</brief_title>
  <acronym>DUET</acronym>
  <official_title>Preventing Toileting Disability in Frail Older Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study to determine the feasibility and possible treatment effect of a multi-component&#xD;
      intervention combining non-drug treatments for urinary incontinence and physical activity to&#xD;
      improve urinary incontinence, toileting skills, physical function, and quality of life in&#xD;
      frail older women without dementia living in senior housing facilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a single blinded, two-arm pilot randomized controlled trial designed to test the&#xD;
      feasibility and potential treatment effects of a multi-component intervention that combined&#xD;
      behavioral urinary incontinence treatments with physical activity to improve urinary&#xD;
      incontinence, toileting skills, quality of life, and physical function in frail older women&#xD;
      without dementia living in senior apartment buildings.The intervention included a 12-week&#xD;
      program of tailored behavioral UI treatments delivered by a nurse practitioner during 4 home&#xD;
      visits, 150 minutes of weekly walking, and twice weekly strength training classes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance Oriented Timed Toileting Instrument (POTTI)</measure>
    <time_frame>baseline, after completing 12 week intervention</time_frame>
    <description>A performance based measure that takes less than 5 minutes to administer. Participants are timed as they complete tasks that simulate toileting including: rising from a chair, walking 15 feet to another chair, turning around, pulling down an elastic waist skirt worn over their typical clothing, sitting in the chair, grabbing a piece of toileting paper and throwing it into a wastebasket, rising and pulling the skirt back up. Longer times indicate greater difficulty with toileting. It has strong inter-rater and test-retest reliability (90% agreement) and has been validated with activities of daily living dependency (r= -.721, p&lt;.001) in nursing home residents (Ouslander et al., 1987). It has demonstrated responsiveness to change in a recent clinical trial (van Houten et. al., 2007).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Toileting Skills Questionnaire</measure>
    <time_frame>baseline, after completing 12 week intervention</time_frame>
    <description>A five item toileting skills questionnaire that assesses participants level of difficulty with undressing, walking to the toilet, getting on and off the toilet, reaching to grab toilet paper, and reaching around to wipe their bottom. Responses for each item range from 0-no difficulty to 4-cannot do. Total scores range from 0-20. Higher scores indicate more difficulty.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>International Consultation on Incontinence Questionnaire (ICIQ)</measure>
    <time_frame>baseline, after completing 12 week intervention</time_frame>
    <description>A four item questionnaire reporting the frequency and amount of urine leakage, how much leakage interferes with everyday life, and when leaking occurs. Scores range from 0-21 with higher scores indicating greater severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3 day bladder diary</measure>
    <time_frame>baseline, after completing 12 week intevention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Battery</measure>
    <time_frame>baseline, after completing 12 week intervention</time_frame>
    <description>Performance based test of balance, gait, and chair rising ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Environmental toileting barriers checklist</measure>
    <time_frame>baseline</time_frame>
    <description>Observation of environmental barriers to toilet access, i.e., inappropriate toilet seat height, grab bar placement, trip hazards on pathway to toilet, adequate lighting in bathroom and pathways to toilet and other barriers to easy toileting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incontinence Impact Questionnaire (IIQ)</measure>
    <time_frame>baseline, after completing 12 week intervention</time_frame>
    <description>The IIQ is a questionnaire with 30 items measuring the impact urinary incontinence has on social, physical, emotional, and psychological aspects of life. All items contain the same response options (0=not at all, 1=slightly, 2= moderately, 3=greatly) and scores range from 0-90.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urogenital Distress Inventory (UDI)</measure>
    <time_frame>baseline, after completing 12 week intevention</time_frame>
    <description>The UDI has 20 items asking about how much urinary incontinence bothers the respondent. All items contain the same response options (0=not at all, 1=slightly, 2= moderately, 3=greatly) and scores range from 0-60.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Toileting Disability</condition>
  <condition>Functional Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>No treatment control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No treatment control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Behavioral Urinary Incontinence Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 week program combining behavioral treatments for urinary incontinence and physical activity</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Defeating Urinary Incontinence with Exercise Training</intervention_name>
    <description>12 week multi-component program. Continence program administered by a nurse practitioner during 4 home visits. Participants do pelvic floor muscle exercises 5 days/week using a 13-minute instructional audio CD. Based on participant symptoms and preferences the following strategies are taught: bladder training, urge and suppression techniques, caffeine reduction, eliminating bladder irritants, medication adjustment, adequate fluid intake, constipation management, and reducing nocturia.&#xD;
2. Physical activity program including moderate intensity walking (30 minutes, 5 days weekly) and twice weekly group strength training sessions using Therabands led by a trained exercise instructor.</description>
    <arm_group_label>Behavioral Urinary Incontinence Treatment</arm_group_label>
    <arm_group_label>No treatment control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age 60 years or older&#xD;
&#xD;
          -  Have urinary incontinence&#xD;
&#xD;
          -  Not currently meeting national recommendations for physical activity (150 minutes of&#xD;
             weekly moderate intensity aerobic exercise and twice weekly strength building&#xD;
             exercise.&#xD;
&#xD;
          -  At risk for functional decline per the Vulnerable Elders Survey (score of 3+)&#xD;
&#xD;
          -  Free of dementia (pass mini-cog screening)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Grade 4 vaginal prolapse or pessary use&#xD;
&#xD;
          -  Orthopedic surgery in past year&#xD;
&#xD;
          -  Urinary retention (catheter use)&#xD;
&#xD;
          -  Neurological cause for urinary incontinence (i.e. Parkinson's Disease, MS)&#xD;
&#xD;
          -  Bladder cancer&#xD;
&#xD;
          -  Bladder or incontinence surgery in past year&#xD;
&#xD;
          -  Recipient of hospice or palliative care&#xD;
&#xD;
          -  Ostomy&#xD;
&#xD;
          -  New prescription or dosage change in past three months for anti-incontinence&#xD;
             medication&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Minnesota School of Nursing</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Talley KMC, Wyman JF, Bronas U, Olson-Kellogg BJ, McCarthy TC. Defeating Urinary Incontinence with Exercise Training: Results of a Pilot Study in Frail Older Women. J Am Geriatr Soc. 2017 Jun;65(6):1321-1327. doi: 10.1111/jgs.14798. Epub 2017 Mar 1.</citation>
    <PMID>28248418</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>May 1, 2019</last_update_submitted>
  <last_update_submitted_qc>May 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Toileting disability</keyword>
  <keyword>Functional urinary incontinence</keyword>
  <keyword>Urinary incontinence</keyword>
  <keyword>Frailty</keyword>
  <keyword>Physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
  </condition_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/NCT02206958
org study id: 1112S07944
nct id: NCT02206958
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pilot study to determine the feasibility and possible treatment effect of a multi-component
      intervention combining non-drug treatments for urinary incontinence and physical activity to
      improve urinary incontinence, toileting skills, physical function, and quality of life in
      frail older women without dementia living in senior housing facilities.
This was a single blinded, two-arm pilot randomized controlled trial designed to test the
      feasibility and potential treatment effects of a multi-component intervention that combined
      behavioral urinary incontinence treatments with physical activity to improve urinary
      incontinence, toileting skills, quality of life, and physical function in frail older women
      without dementia living in senior apartment buildings.The intervention included a 12-week
      program of tailored behavioral UI treatments delivered by a nurse practitioner during 4 home
      visits, 150 minutes of weekly walking, and twice weekly strength training classes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Performance Oriented Timed Toileting Instrument (POTTI)
time frame: baseline, after completing 12 week intervention
description: A performance based measure that takes less than 5 minutes to administer. Participants are timed as they complete tasks that simulate toileting including: rising from a chair, walking 15 feet to another chair, turning around, pulling down an elastic waist skirt worn over their typical clothing, sitting in the chair, grabbing a piece of toileting paper and throwing it into a wastebasket, rising and pulling the skirt back up. Longer times indicate greater difficulty with toileting. It has strong inter-rater and test-retest reliability (90% agreement) and has been validated with activities of daily living dependency (r= -.721, p<.001) in nursing home residents (Ouslander et al., 1987). It has demonstrated responsiveness to change in a recent clinical trial (van Houten et. al., 2007).
measure: Toileting Skills Questionnaire
time frame: baseline, after completing 12 week intervention
description: A five item toileting skills questionnaire that assesses participants level of difficulty with undressing, walking to the toilet, getting on and off the toilet, reaching to grab toilet paper, and reaching around to wipe their bottom. Responses for each item range from 0-no difficulty to 4-cannot do. Total scores range from 0-20. Higher scores indicate more difficulty.
measure: International Consultation on Incontinence Questionnaire (ICIQ)
time frame: baseline, after completing 12 week intervention
description: A four item questionnaire reporting the frequency and amount of urine leakage, how much leakage interferes with everyday life, and when leaking occurs. Scores range from 0-21 with higher scores indicating greater severity.
measure: 3 day bladder diary
time frame: baseline, after completing 12 week intevention
measure: Short Physical Performance Battery
time frame: baseline, after completing 12 week intervention
description: Performance based test of balance, gait, and chair rising ability.
measure: Environmental toileting barriers checklist
time frame: baseline
description: Observation of environmental barriers to toilet access, i.e., inappropriate toilet seat height, grab bar placement, trip hazards on pathway to toilet, adequate lighting in bathroom and pathways to toilet and other barriers to easy toileting.
measure: Incontinence Impact Questionnaire (IIQ)
time frame: baseline, after completing 12 week intervention
description: The IIQ is a questionnaire with 30 items measuring the impact urinary incontinence has on social, physical, emotional, and psychological aspects of life. All items contain the same response options (0=not at all, 1=slightly, 2= moderately, 3=greatly) and scores range from 0-90.
measure: Urogenital Distress Inventory (UDI)
time frame: baseline, after completing 12 week intevention
description: The UDI has 20 items asking about how much urinary incontinence bothers the respondent. All items contain the same response options (0=not at all, 1=slightly, 2= moderately, 3=greatly) and scores range from 0-60.
arm group label: No treatment control group
arm group type: Other
description: No treatment control group
arm group label: Behavioral Urinary Incontinence Treatment
arm group type: Experimental
description: 12 week program combining behavioral treatments for urinary incontinence and physical activity
intervention type: Behavioral
intervention name: Defeating Urinary Incontinence with Exercise Training
description: 12 week multi-component program. Continence program administered by a nurse practitioner during 4 home visits. Participants do pelvic floor muscle exercises 5 days/week using a 13-minute instructional audio CD. Based on participant symptoms and preferences the following strategies are taught: bladder training, urge and suppression techniques, caffeine reduction, eliminating bladder irritants, medication adjustment, adequate fluid intake, constipation management, and reducing nocturia.
2. Physical activity program including moderate intensity walking (30 minutes, 5 days weekly) and twice weekly group strength training sessions using Therabands led by a trained exercise instructor.
arm group label: Behavioral Urinary Incontinence Treatment
arm group label: No treatment control group
criteria: 
gender: Female
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Talley KMC, Wyman JF, Bronas U, Olson-Kellogg BJ, McCarthy TC. Defeating Urinary Incontinence with Exercise Training: Results of a Pilot Study in Frail Older Women. J Am Geriatr Soc. 2017 Jun;65(6):1321-1327. doi: 10.1111/jgs.14798. Epub 2017 Mar 1.
PMID: 28248418
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No