Vesico Vaginal Fistula
Conditions
Keywords
vesicovaginal fistula, urinary catheter, catheter extension
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.
Interventions
DEVICECatheter extension
Foley transurethral catheter placed to allow continuous drainage of urine.
Sponsors
Evangel VVF Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fistula closure | 3 months post-repair | Successful closure of the fistula, as defined by patient self-reporting no urinary leakage AND a negative dye test proving no fistulous leak |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary continence | 3 months post-repair | Patient is completely continent of urine with no reported OR demonstrable leakage of dye on inspection. |
| Closure and continence at hospital discharge | Date of discharge (7-28 days post-repair) | Rates of fistula closure and complete urinary continence at the time of hospital discharge |
| Complications | Duration of hospitalization (minimum 7 days, maximum 28 days post-repair) | Rates of complications or urinary tract infections during hospitalization |
Outcome results
None listed