<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/NCT03289117</url>
  </required_header>
  <id_info>
    <org_study_id>2016 02 01 ver 1_1</org_study_id>
    <nct_id>NCT03289117</nct_id>
  </id_info>
  <brief_title>Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters</brief_title>
  <official_title>Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Indwelling Urinary Catheters - a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vinnova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Innovation Skåne AB/ Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Skane</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, open label, controlled, parallel group study to investigate difference between&#xD;
      regional standard procedure and a novel modified procedure (using an additional novel device&#xD;
      to facilitate gel installation) for changing long-term indwelling urinary catheters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, open label, controlled, parallel group study, which comprises one visit&#xD;
      that includes: assessment for eligibility, randomization to one of two treatment&#xD;
      alternatives, followed by the actual intervention and evaluation of outcomes.&#xD;
&#xD;
      The interventions are either change of catheter according to the regional standard procedure&#xD;
      (the comparator group) or change of catheter with the additional use of the novel device to&#xD;
      facilitate gel instillation and a slightly modified procedure (the experimental group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2016</start_date>
  <completion_date type="Actual">May 26, 2017</completion_date>
  <primary_completion_date type="Actual">May 26, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Arm 1: Experimental: Novel device: Assigned Interventions: Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device.&#xD;
Arm 2: Comparator: Standard procedure: Assigned Interventions: Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment duration (min)</measure>
    <time_frame>During procedure</time_frame>
    <description>Treatment duration for procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's perceived pain (NRS scale)</measure>
    <time_frame>During intervention</time_frame>
    <description>Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of gel syringes used</measure>
    <time_frame>During intervention</time_frame>
    <description>Number of pre-filled gel syringes used during the procedure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>During intervention</time_frame>
    <description>Incidence of Treatment-Emergent Adverse Events found during procedure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Urinary Catheters</condition>
  <condition>Retention, Urinary</condition>
  <condition>Incontinence, Urinary</condition>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Novel gel installation device procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Catheter change with novel device.&#xD;
Each subject will undergo catheter change with novel gel instillation device procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Catheter change with standard procedure.&#xD;
Each subject will undergo catheter change with standard procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Novel gel installation device procedure</intervention_name>
    <description>Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device</description>
    <arm_group_label>Novel gel installation device procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard procedure</intervention_name>
    <description>Catheter change with standard procedure Each subject will undergo catheter change with standard procedure</description>
    <arm_group_label>Standard procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient has an indwelling catheter and a primary diagnosis that justify continued&#xD;
             catheter use&#xD;
&#xD;
          -  The patient provides informed consent prior to any study specific procedures&#xD;
&#xD;
          -  The patient is considered to benefit from participation in the clinical study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient do not consent to participate in the study&#xD;
&#xD;
          -  Trauma to urethra or bladder&#xD;
&#xD;
          -  Infection to urethra or bladder&#xD;
&#xD;
          -  Other diagnosis that contraindicates participation in the clinical study as judged by&#xD;
             the responsible physician&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulf Malmqvist, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Studies Sweden - Forum South</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skåne University Hospital - Urology clinic - Homecare unit</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>October 19, 2017</last_update_submitted>
  <last_update_submitted_qc>October 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urinary catheterization</keyword>
  <keyword>Gel installation</keyword>
  <keyword>Novel medical device</keyword>
  <keyword>Indwelling urinary catheter</keyword>
  <keyword>Long-term urinary catheter</keyword>
  <keyword>Male patients</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>
    <mesh_term>Urinary Retention</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/NCT03289117
org study id: 2016 02 01 ver 1_1
nct id: NCT03289117
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A randomized, open label, controlled, parallel group study to investigate difference between
      regional standard procedure and a novel modified procedure (using an additional novel device
      to facilitate gel installation) for changing long-term indwelling urinary catheters.
This is a randomized, open label, controlled, parallel group study, which comprises one visit
      that includes: assessment for eligibility, randomization to one of two treatment
      alternatives, followed by the actual intervention and evaluation of outcomes.

      The interventions are either change of catheter according to the regional standard procedure
      (the comparator group) or change of catheter with the additional use of the novel device to
      facilitate gel instillation and a slightly modified procedure (the experimental group).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Arm 1: Experimental: Novel device: Assigned Interventions: Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device.
Arm 2: Comparator: Standard procedure: Assigned Interventions: Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Open label
measure: Treatment duration (min)
time frame: During procedure
description: Treatment duration for procedure
measure: Patient's perceived pain (NRS scale)
time frame: During intervention
description: Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale)
measure: Number of gel syringes used
time frame: During intervention
description: Number of pre-filled gel syringes used during the procedure
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: During intervention
description: Incidence of Treatment-Emergent Adverse Events found during procedure
arm group label: Novel gel installation device procedure
arm group type: Experimental
description: Catheter change with novel device.
Each subject will undergo catheter change with novel gel instillation device procedure
arm group label: Standard procedure
arm group type: Active Comparator
description: Catheter change with standard procedure.
Each subject will undergo catheter change with standard procedure
intervention type: Device
intervention name: Novel gel installation device procedure
description: Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device
arm group label: Novel gel installation device procedure
intervention type: Device
intervention name: Standard procedure
description: Catheter change with standard procedure Each subject will undergo catheter change with standard procedure
arm group label: Standard procedure
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ulf Malmqvist, PhD
role: Principal Investigator
affiliation: Clinical Studies Sweden - Forum South
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Retention
sharing ipd: No