<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/NCT03828968</url>
  </required_header>
  <id_info>
    <org_study_id>35RC18_3063_RUC EHPAD</org_study_id>
    <nct_id>NCT03828968</nct_id>
  </id_info>
  <brief_title>Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening</brief_title>
  <acronym>RUC EHPAD</acronym>
  <official_title>Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this cross-sectional, multicentric and descriptive epidemiological study is to&#xD;
      assess the prevalence of chronic urinary retention (CUR) in elderly living in residential&#xD;
      care for dependent elderly people in order to determine if there is an interest in offering&#xD;
      them a bladder scan screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main goal of this study is to assess the prevalence of CUR in elderly living in homes for&#xD;
      the aged, the secondary ones are to evaluate the risk factors and complications of CUR.&#xD;
&#xD;
      We will carry out this prevalence study in 5 centres whit a draw of 40 residents per centre.&#xD;
      Following an information and a non-opposition of the patients, we will collect datas in their&#xD;
      medical file (age, medical history and comorbidities, current treatments, anticholinergic&#xD;
      score according to the ADS (Anticholinergic Drug Scale), GIR score according to the AGGIR&#xD;
      scale (Autonomie Gérontologique Groupes Iso Ressources), FAC modified score (Functional&#xD;
      Ambulation Classification modified), MMSE score (Mini Mental State Examination),&#xD;
      communicative capacity, notion of fall and date of last fall, knowledge of urinary&#xD;
      incontinence, knowledge of constipation, knowledge of previous urinary screening by bladder&#xD;
      scan and previous urological consulting, last urinalysis and its results, last analysis of&#xD;
      creatinemia and creatinine clearance according to CKD-EPI) and we will perform up to 3&#xD;
      measurements of vesical volume by bladder scan.&#xD;
&#xD;
      The expected results are a prevalence of CUR between 10 and 20 % among people living in homes&#xD;
      for the aged with more urinary tract infections, renal insufficiency and falls in the CUR&#xD;
      group showing the interest of screening for CUR by bladder scan in elderly people living in&#xD;
      nursing homes according to risk groups based on the risk factors found.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2019</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chronic urinary retention</measure>
    <time_frame>4 weeks after inclusion</time_frame>
    <description>Chronic urinary retention definition : post-void residual urine &gt; 250 mL twice without any clinical argument for acute urinary retention.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Urinary Retention</condition>
  <arm_group>
    <arm_group_label>Bladder scan</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Bladder scan performed on resident in homes for aged</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>bladder scan</intervention_name>
    <description>Measurement of vesical volume by bladder scan</description>
    <arm_group_label>Bladder scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult people&#xD;
&#xD;
          -  Residents in a participating nursing home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Resident with indwelling urinary catheter or regular urinary catheterisation&#xD;
&#xD;
          -  Resident or legal representative opposing participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thibaud HONORE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>EHPAD du Centre Local Hospitalier de Saint-Joseph</name>
      <address>
        <city>Combourg</city>
        <zip>35270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EHPAD du Centre Hospitalier de Fougères</name>
      <address>
        <city>Fougères</city>
        <zip>35300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EHPAD Hôtel-Dieu</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EHPAD de Saint-Brice-en-Coglès</name>
      <address>
        <city>Saint-Brice-en-Coglès</city>
        <zip>35460</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EHPAD de Saint-Georges-de-Reintembault</name>
      <address>
        <city>Saint-Georges-de-Reintembault</city>
        <zip>35420</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>urinary retention</keyword>
  <keyword>chronic disease</keyword>
  <keyword>aged</keyword>
  <keyword>homes for the aged</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Retention</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/NCT03828968
org study id: 35RC18_3063_RUC EHPAD
nct id: NCT03828968
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this cross-sectional, multicentric and descriptive epidemiological study is to
      assess the prevalence of chronic urinary retention (CUR) in elderly living in residential
      care for dependent elderly people in order to determine if there is an interest in offering
      them a bladder scan screening.
The main goal of this study is to assess the prevalence of CUR in elderly living in homes for
      the aged, the secondary ones are to evaluate the risk factors and complications of CUR.

      We will carry out this prevalence study in 5 centres whit a draw of 40 residents per centre.
      Following an information and a non-opposition of the patients, we will collect datas in their
      medical file (age, medical history and comorbidities, current treatments, anticholinergic
      score according to the ADS (Anticholinergic Drug Scale), GIR score according to the AGGIR
      scale (Autonomie Gérontologique Groupes Iso Ressources), FAC modified score (Functional
      Ambulation Classification modified), MMSE score (Mini Mental State Examination),
      communicative capacity, notion of fall and date of last fall, knowledge of urinary
      incontinence, knowledge of constipation, knowledge of previous urinary screening by bladder
      scan and previous urological consulting, last urinalysis and its results, last analysis of
      creatinemia and creatinine clearance according to CKD-EPI) and we will perform up to 3
      measurements of vesical volume by bladder scan.

      The expected results are a prevalence of CUR between 10 and 20 % among people living in homes
      for the aged with more urinary tract infections, renal insufficiency and falls in the CUR
      group showing the interest of screening for CUR by bladder scan in elderly people living in
      nursing homes according to risk groups based on the risk factors found.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Chronic urinary retention
time frame: 4 weeks after inclusion
description: Chronic urinary retention definition : post-void residual urine > 250 mL twice without any clinical argument for acute urinary retention.
arm group label: Bladder scan
arm group type: Other
description: Bladder scan performed on resident in homes for aged
intervention type: Diagnostic Test
intervention name: bladder scan
description: Measurement of vesical volume by bladder scan
arm group label: Bladder scan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thibaud HONORE, MD
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Urinary Retention