<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/NCT03029130</url>
  </required_header>
  <id_info>
    <org_study_id>EvangelWFC</org_study_id>
    <nct_id>NCT03029130</nct_id>
  </id_info>
  <brief_title>Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures</brief_title>
  <official_title>Does Extending Catheterization Improve Outcomes in Early Vesicovaginal Fistula Repair Failures? A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Evangel VVF Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Evangel VVF Centre</source>
  <oversight_info>
    <has_dmc>Yes</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 study evaluates the use of extending time of continual urinary drainage (using&#xD;
      transurethral foley catheter) for patients with early failures of vesicovaginal fistula&#xD;
      repairs. Half of those included will be randomized to replacement of foley catheter for a&#xD;
      length of 14 additional days, while the other half will be discharged (no intervention). Both&#xD;
      groups will be examined for outcomes at 3 months post-repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At present, there is no standard of care nor consensus for the proper management of repaired&#xD;
      vesicovaginal fistulas that begin leaking prior to or immediately after scheduled catheter&#xD;
      removal. In the past, extension of time with catheterization has been tried, with patients&#xD;
      becoming fully healed by the time of catheter removal. However, some patients who are&#xD;
      discharged with a fistulous leak later return at follow up completely dry, with a closed and&#xD;
      healed fistula. This study will compare, in a prospective, randomized manner, extension of&#xD;
      catheterization vs no intervention, to see if in such patients extending catheterization will&#xD;
      improve their likelihood of complete fistula healing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fistula closure</measure>
    <time_frame>3 months post-repair</time_frame>
    <description>Successful closure of the fistula, as defined by patient self-reporting no urinary leakage AND a negative dye test proving no fistulous leak</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary continence</measure>
    <time_frame>3 months post-repair</time_frame>
    <description>Patient is completely continent of urine with no reported OR demonstrable leakage of dye on inspection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Closure and continence at hospital discharge</measure>
    <time_frame>Date of discharge (7-28 days post-repair)</time_frame>
    <description>Rates of fistula closure and complete urinary continence at the time of hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Duration of hospitalization (minimum 7 days, maximum 28 days post-repair)</time_frame>
    <description>Rates of complications or urinary tract infections during hospitalization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">232</enrollment>
  <condition>Vesico Vaginal Fistula</condition>
  <arm_group>
    <arm_group_label>Catheter Extension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will have a foley catheter re-passed, to remain in situ for an additional 14 days, after which time the catheter will be removed and the patient discharged to return for follow up exam at 3 months postop.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discharge</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this arm will be discharged, to return for follow up exam at 3 months postop.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Catheter extension</intervention_name>
    <description>Foley transurethral catheter placed to allow continuous drainage of urine.</description>
    <arm_group_label>Catheter Extension</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who present with a vesicovaginal fistula for surgical repair AND who, at the&#xD;
             time of initial catheter removal (7 or 14 days post-repair), have demonstrable&#xD;
             fistulous leak on dye test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV infection,&#xD;
&#xD;
          -  concomitant bladder stone(s),&#xD;
&#xD;
          -  one or more ureters outside of the bladder,&#xD;
&#xD;
          -  urethrovaginal fistula,&#xD;
&#xD;
          -  multiple fistulas (more than one),&#xD;
&#xD;
          -  dye leak / fistulous leak present at end of surgical procedure,&#xD;
&#xD;
          -  radiation-induced fistula,&#xD;
&#xD;
          -  fistula caused by cancer or infection (such as lymphogranuloma venereum),&#xD;
&#xD;
          -  continence procedures being performed (such as pubovaginal sling),&#xD;
&#xD;
          -  rectovaginal fistula,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  fistula breakdown of greater than 2cm identified on postoperative dye test.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Evangel VVF Centre</investigator_affiliation>
    <investigator_full_name>Steven Shephard</investigator_full_name>
    <investigator_title>Fistula Surgeon</investigator_title>
  </responsible_party>
  <keyword>vesicovaginal fistula</keyword>
  <keyword>urinary catheter</keyword>
  <keyword>catheter extension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginal Fistula</mesh_term>
    <mesh_term>Vesicovaginal Fistula</mesh_term>
    <mesh_term>Fistula</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/NCT03029130
org study id: EvangelWFC
nct id: NCT03029130
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the use of extending time of continual urinary drainage (using
      transurethral foley catheter) for patients with early failures of vesicovaginal fistula
      repairs. Half of those included will be randomized to replacement of foley catheter for a
      length of 14 additional days, while the other half will be discharged (no intervention). Both
      groups will be examined for outcomes at 3 months post-repair.
At present, there is no standard of care nor consensus for the proper management of repaired
      vesicovaginal fistulas that begin leaking prior to or immediately after scheduled catheter
      removal. In the past, extension of time with catheterization has been tried, with patients
      becoming fully healed by the time of catheter removal. However, some patients who are
      discharged with a fistulous leak later return at follow up completely dry, with a closed and
      healed fistula. This study will compare, in a prospective, randomized manner, extension of
      catheterization vs no intervention, to see if in such patients extending catheterization will
      improve their likelihood of complete fistula healing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fistula closure
time frame: 3 months post-repair
description: Successful closure of the fistula, as defined by patient self-reporting no urinary leakage AND a negative dye test proving no fistulous leak
measure: Urinary continence
time frame: 3 months post-repair
description: Patient is completely continent of urine with no reported OR demonstrable leakage of dye on inspection.
measure: Closure and continence at hospital discharge
time frame: Date of discharge (7-28 days post-repair)
description: Rates of fistula closure and complete urinary continence at the time of hospital discharge
measure: Complications
time frame: Duration of hospitalization (minimum 7 days, maximum 28 days post-repair)
description: Rates of complications or urinary tract infections during hospitalization
arm group label: Catheter Extension
arm group type: Experimental
description: Patients in this arm will have a foley catheter re-passed, to remain in situ for an additional 14 days, after which time the catheter will be removed and the patient discharged to return for follow up exam at 3 months postop.
arm group label: Discharge
arm group type: No Intervention
description: Patients in this arm will be discharged, to return for follow up exam at 3 months postop.
intervention type: Device
intervention name: Catheter extension
description: Foley transurethral catheter placed to allow continuous drainage of urine.
arm group label: Catheter Extension
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Evangel VVF Centre
investigator full name: Steven Shephard
investigator title: Fistula Surgeon
mesh term: Vaginal Fistula
mesh term: Vesicovaginal Fistula
mesh term: Fistula
sharing ipd: No