<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/NCT03028753</url>
  </required_header>
  <id_info>
    <org_study_id>11871</org_study_id>
    <nct_id>NCT03028753</nct_id>
  </id_info>
  <brief_title>Accuracy of Bladder Scanners in Post-operative Voiding Trials</brief_title>
  <official_title>Accuracy of Bladder Scanners in Post-operative Voiding Trials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tufts Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are trying to determine if using a bladder scanner (type of ultrasound) to&#xD;
      check how much urine is left in the bladder is the same as checking that volume with a&#xD;
      catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery, the&#xD;
      investigators perform a voiding trial. Water is put into the participant's bladder through&#xD;
      the catheter (tube draining your bladder). The catheter is then removed and the participant&#xD;
      is asked to empty their bladder. After that, the investigators will use the bladder scanner&#xD;
      (ultrasound) to see how much urine is left in the participant's bladder. After the&#xD;
      ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take&#xD;
      out the remaining urine. The investigators will then compare the amount obtained from the&#xD;
      catheter to the ultrasound amount. This will also help the investigators to figure out if&#xD;
      they need to check how much urine is left in a patient's bladder after the voiding trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this study is to determine if bladder scanners are accurate in determining&#xD;
      a post-void residual volume (PVR) after Urogynecologic surgery.&#xD;
&#xD;
      The secondary aim of this study is to determine if a post-void residual volume (PVR)&#xD;
      measurement is needed after a back-fill voiding trial on Urogynecologic post-op patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    study coordinator left / no other current resources to complete&#xD;
  </why_stopped>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery</measure>
    <time_frame>Within 48 hours after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine if a post void residual volume measurement is needed after a back-fill voiding trial after urogynecologic surgery</measure>
    <time_frame>Within 48 hours after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pelvic Floor Disorders</condition>
  <arm_group>
    <arm_group_label>All subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects enrolled in the study will have a back-fill voiding trial performed at the time of catheter removal after urogynecologic surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bladder scan post void residual</intervention_name>
    <description>After voiding on the commode, all subjects will have a post void residual measured by bladder scanner</description>
    <arm_group_label>All subjects</arm_group_label>
    <other_name>Verathon BVI9400 Bladder scanner</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Straight catheter post void residual</intervention_name>
    <description>After voiding on the commode and having a post void residual measured by bladder scanner, all subjects will have a post void residual measured by straight catheter performed with usual sterile technique.</description>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Back fill voiding trial</intervention_name>
    <description>Prior to catheter removal, all subjects will undergo a back fill voiding trial. The bag of the foley catheter will be removed and the subjects bladder will be filled with 300cc of normal saline (or as much as they can tolerate). The foley catheter will then be removed and the subject will be asked to void on the commode. The voided volume will be measured.</description>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing Urogynecologic surgery&#xD;
&#xD;
          -  Able to consent&#xD;
&#xD;
          -  Greater than 18 years old&#xD;
&#xD;
          -  Non pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need for prolonged catheterization&#xD;
&#xD;
          -  Unable to consent&#xD;
&#xD;
          -  Prisoner&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tanaz Ferzandi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>March 5, 2020</last_update_submitted>
  <last_update_submitted_qc>March 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</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>Pelvic Floor Disorders</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/NCT03028753
org study id: 11871
nct id: NCT03028753
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The investigators are trying to determine if using a bladder scanner (type of ultrasound) to
      check how much urine is left in the bladder is the same as checking that volume with a
      catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery, the
      investigators perform a voiding trial. Water is put into the participant's bladder through
      the catheter (tube draining your bladder). The catheter is then removed and the participant
      is asked to empty their bladder. After that, the investigators will use the bladder scanner
      (ultrasound) to see how much urine is left in the participant's bladder. After the
      ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take
      out the remaining urine. The investigators will then compare the amount obtained from the
      catheter to the ultrasound amount. This will also help the investigators to figure out if
      they need to check how much urine is left in a patient's bladder after the voiding trial.
The primary aim of this study is to determine if bladder scanners are accurate in determining
      a post-void residual volume (PVR) after Urogynecologic surgery.

      The secondary aim of this study is to determine if a post-void residual volume (PVR)
      measurement is needed after a back-fill voiding trial on Urogynecologic post-op patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery
time frame: Within 48 hours after surgery
measure: Determine if a post void residual volume measurement is needed after a back-fill voiding trial after urogynecologic surgery
time frame: Within 48 hours after surgery
arm group label: All subjects
arm group type: Experimental
description: All subjects enrolled in the study will have a back-fill voiding trial performed at the time of catheter removal after urogynecologic surgery.
intervention type: Device
intervention name: Bladder scan post void residual
description: After voiding on the commode, all subjects will have a post void residual measured by bladder scanner
arm group label: All subjects
other name: Verathon BVI9400 Bladder scanner
intervention type: Procedure
intervention name: Straight catheter post void residual
description: After voiding on the commode and having a post void residual measured by bladder scanner, all subjects will have a post void residual measured by straight catheter performed with usual sterile technique.
arm group label: All subjects
intervention type: Procedure
intervention name: Back fill voiding trial
description: Prior to catheter removal, all subjects will undergo a back fill voiding trial. The bag of the foley catheter will be removed and the subjects bladder will be filled with 300cc of normal saline (or as much as they can tolerate). The foley catheter will then be removed and the subject will be asked to void on the commode. The voided volume will be measured.
arm group label: All subjects
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tanaz Ferzandi, MD
role: Principal Investigator
affiliation: Tufts Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pelvic Floor Disorders