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Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures

Primary Purpose

Vesico Vaginal Fistula

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Catheter extension
Sponsored by
Evangel VVF Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vesico Vaginal Fistula focused on measuring vesicovaginal fistula, urinary catheter, catheter extension

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women who present with a vesicovaginal fistula for surgical repair AND who, at the time of initial catheter removal (7 or 14 days post-repair), have demonstrable fistulous leak on dye test

Exclusion Criteria:

  • HIV infection,
  • concomitant bladder stone(s),
  • one or more ureters outside of the bladder,
  • urethrovaginal fistula,
  • multiple fistulas (more than one),
  • dye leak / fistulous leak present at end of surgical procedure,
  • radiation-induced fistula,
  • fistula caused by cancer or infection (such as lymphogranuloma venereum),
  • continence procedures being performed (such as pubovaginal sling),
  • rectovaginal fistula,
  • pregnancy,
  • fistula breakdown of greater than 2cm identified on postoperative dye test.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Catheter Extension

    Discharge

    Arm 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.

    Patients in this arm will be discharged, to return for follow up exam at 3 months postop.

    Outcomes

    Primary Outcome Measures

    Fistula closure
    Successful closure of the fistula, as defined by patient self-reporting no urinary leakage AND a negative dye test proving no fistulous leak

    Secondary Outcome Measures

    Urinary continence
    Patient is completely continent of urine with no reported OR demonstrable leakage of dye on inspection.
    Closure and continence at hospital discharge
    Rates of fistula closure and complete urinary continence at the time of hospital discharge
    Complications
    Rates of complications or urinary tract infections during hospitalization

    Full Information

    First Posted
    January 20, 2017
    Last Updated
    January 23, 2017
    Sponsor
    Evangel VVF Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03029130
    Brief Title
    Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures
    Official Title
    Does Extending Catheterization Improve Outcomes in Early Vesicovaginal Fistula Repair Failures? A Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    March 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Evangel VVF Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vesico Vaginal Fistula
    Keywords
    vesicovaginal fistula, urinary catheter, catheter extension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    232 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Catheter Extension
    Arm Type
    Experimental
    Arm 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 Title
    Discharge
    Arm Type
    No Intervention
    Arm Description
    Patients in this arm will be discharged, to return for follow up exam at 3 months postop.
    Intervention Type
    Device
    Intervention Name(s)
    Catheter extension
    Intervention Description
    Foley transurethral catheter placed to allow continuous drainage of urine.
    Primary Outcome Measure Information:
    Title
    Fistula closure
    Description
    Successful closure of the fistula, as defined by patient self-reporting no urinary leakage AND a negative dye test proving no fistulous leak
    Time Frame
    3 months post-repair
    Secondary Outcome Measure Information:
    Title
    Urinary continence
    Description
    Patient is completely continent of urine with no reported OR demonstrable leakage of dye on inspection.
    Time Frame
    3 months post-repair
    Title
    Closure and continence at hospital discharge
    Description
    Rates of fistula closure and complete urinary continence at the time of hospital discharge
    Time Frame
    Date of discharge (7-28 days post-repair)
    Title
    Complications
    Description
    Rates of complications or urinary tract infections during hospitalization
    Time Frame
    Duration of hospitalization (minimum 7 days, maximum 28 days post-repair)

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women who present with a vesicovaginal fistula for surgical repair AND who, at the time of initial catheter removal (7 or 14 days post-repair), have demonstrable fistulous leak on dye test Exclusion Criteria: HIV infection, concomitant bladder stone(s), one or more ureters outside of the bladder, urethrovaginal fistula, multiple fistulas (more than one), dye leak / fistulous leak present at end of surgical procedure, radiation-induced fistula, fistula caused by cancer or infection (such as lymphogranuloma venereum), continence procedures being performed (such as pubovaginal sling), rectovaginal fistula, pregnancy, fistula breakdown of greater than 2cm identified on postoperative dye test.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures

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