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Does Extending Catheterization Improve Outcomes in Early Vesicovaginal Fistula Repair Failures? A Prospective Randomized Controlled Trial (NCT03029130)

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.
  • Device: Catheter extension
    Foley transurethral catheter placed to allow continuous drainage of urine.
    Ages eligible for Study
    all
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    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.
    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.
    Status:
    enrolling by invitation
    Type:
    Interventional
    Phase:
    -
    Start:
    31 December, 2016
    Updated:
    22 January, 2017
    Participants:
    232
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