Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Extending Catheterization Improve Outcomes in Early Vesicovaginal Fistula Repair Failures? A Prospective Randomized Controlled Trial

Conditions
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Vesico Vaginal Fistula

Intervention / Treatment
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* Device: Catheter extension


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter Extension<br>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. | Device: Catheter extension<br>* Foley transurethral catheter placed to allow continuous drainage of urine.<br>|
| No Intervention: Discharge<br>Patients in this arm will be discharged, to return for follow up exam at 3 months postop. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months post-repair | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary continence | Patient is completely continent of urine with no reported OR demonstrable leakage of dye on inspection. | 3 months post-repair | 
| Closure and continence at hospital discharge | Rates of fistula closure and complete urinary continence at the time of hospital discharge | Date of discharge (7-28 days post-repair) | 
| Complications | Rates of complications or urinary tract infections during hospitalization | Duration of hospitalization (minimum 7 days, maximum 28 days post-repair) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vesicovaginal fistula, urinary catheter, catheter extension