<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/NCT03263676</url>
  </required_header>
  <id_info>
    <org_study_id>2016-042</org_study_id>
    <nct_id>NCT03263676</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads</brief_title>
  <official_title>Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medstar Health Research Institute</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>
      This is a randomized cross over trial to compare quality of life and product performance&#xD;
      between Icon reusable underwear versus standard disposable pad in patients with mild to&#xD;
      moderate urinary incontinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary incontinence is estimated to affect approximately 1/5 of all women in the United&#xD;
      States. Multiple studies have compared effectiveness, cost-effectiveness and comfort of a&#xD;
      variety absorbent products but most of the current data compares daily disposable insert&#xD;
      pads. Icon reusable underwear is a new product on the market for light incontinence (25-30mL&#xD;
      daily). The primary objective of this randomized cross over trial is to compare quality of&#xD;
      life and patient comfort and to determine patient preference using Icon reusable underwear&#xD;
      versus standard incontinence pad in the management of urinary incontinence. The secondary&#xD;
      objective is to compare the cost-effectiveness of ICON underwear to disposable pads. Women&#xD;
      with small to moderate urinary incontinence to use either ICON underwear or pads for two days&#xD;
      and then crossed over to use other product for two days. The primary outcome measures were&#xD;
      Incontinence Quality of Life Instrument 3 (I-QOL) and Product Performance Questionnaire 4&#xD;
      (PPQ) after use of each product. A sample size of 70 was calculated to detect a difference of&#xD;
      10.0 in the I-QOL to achieve a power of 80% with a significance level of 0.05 and to account&#xD;
      for a 20% attrition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">April 1, 2017</completion_date>
  <primary_completion_date type="Actual">March 1, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incontinence Quality of Life Questionnaire</measure>
    <time_frame>2 days</time_frame>
    <description>Validated quality of life questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Product Performance Questionnaire</measure>
    <time_frame>2 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Reusable Underwear, Urinary Incontinence, Dispoable Pad</condition>
  <arm_group>
    <arm_group_label>Icon reusable underwear</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Disposable pad</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Icon resuable underwear</intervention_name>
    <description>Reusable incontinence underwear</description>
    <arm_group_label>Disposable pad</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Disposable pad</intervention_name>
    <description>Standard market disposable pad</description>
    <arm_group_label>Icon reusable underwear</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients who are at least 18yo&#xD;
&#xD;
          -  Mild to moderate urinary incontinence, defined as a response &quot;small&quot; or &quot;moderate&quot;&#xD;
             amount to the ICIQ-SF question - &quot;How much do you leak?&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active urinary tract infection&#xD;
&#xD;
          -  Fecal incontinence, defined as a response &quot;large&quot; amount to the ICIQ-SF question -&#xD;
             &quot;How much do you leak?&quot;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee Richter</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medstar Washington Hospital Center</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</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 Incontinence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03263676
org study id: 2016-042
nct id: NCT03263676
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized cross over trial to compare quality of life and product performance
      between Icon reusable underwear versus standard disposable pad in patients with mild to
      moderate urinary incontinence.
Urinary incontinence is estimated to affect approximately 1/5 of all women in the United
      States. Multiple studies have compared effectiveness, cost-effectiveness and comfort of a
      variety absorbent products but most of the current data compares daily disposable insert
      pads. Icon reusable underwear is a new product on the market for light incontinence (25-30mL
      daily). The primary objective of this randomized cross over trial is to compare quality of
      life and patient comfort and to determine patient preference using Icon reusable underwear
      versus standard incontinence pad in the management of urinary incontinence. The secondary
      objective is to compare the cost-effectiveness of ICON underwear to disposable pads. Women
      with small to moderate urinary incontinence to use either ICON underwear or pads for two days
      and then crossed over to use other product for two days. The primary outcome measures were
      Incontinence Quality of Life Instrument 3 (I-QOL) and Product Performance Questionnaire 4
      (PPQ) after use of each product. A sample size of 70 was calculated to detect a difference of
      10.0 in the I-QOL to achieve a power of 80% with a significance level of 0.05 and to account
      for a 20% attrition.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Incontinence Quality of Life Questionnaire
time frame: 2 days
description: Validated quality of life questionnaire
measure: Product Performance Questionnaire
time frame: 2 days
arm group label: Icon reusable underwear
arm group type: Experimental
arm group label: Disposable pad
arm group type: Placebo Comparator
intervention type: Device
intervention name: Icon resuable underwear
description: Reusable incontinence underwear
arm group label: Disposable pad
intervention type: Device
intervention name: Disposable pad
description: Standard market disposable pad
arm group label: Icon reusable underwear
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lee Richter
role: Principal Investigator
affiliation: Medstar Washington Hospital Center
responsible party type: Sponsor
mesh term: Urinary Incontinence
sharing ipd: Undecided