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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Extension | Experimental | 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. |
|
| Discharge | No Intervention | Patients in this arm will be discharged, to return for follow up exam at 3 months postop. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter extension | Device | Foley transurethral catheter placed to allow continuous drainage of urine. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014719 | Vesicovaginal Fistula |
| ID | Term |
|---|---|
| D014624 | Vaginal Fistula |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| 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) |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001747 | Urinary Bladder Fistula |
| D014548 | Urinary Fistula |
| D014564 | Urogenital Abnormalities |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D000091662 | Genital Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |