Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures

Evangel VVF Centre232 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

232

Conditions

Vesico Vaginal Fistula

Interventions

Catheter extensionDEVICE

Foley transurethral catheter placed to allow continuous drainage of urine.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 3 months post-repair

Secondary Outcomes

Urinary continence

Patient is completely continent of urine with no reported OR demonstrable leakage of dye on inspection.

Time frame: 3 months post-repair

Closure and continence at hospital discharge

Rates of fistula closure and complete urinary continence at the time of hospital discharge

Time frame: Date of discharge (7-28 days post-repair)

Complications

Rates of complications or urinary tract infections during hospitalization

Time frame: Duration of hospitalization (minimum 7 days, maximum 28 days post-repair)

Data from ClinicalTrials.gov

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