An interventional study of Catheter extension in Vesico Vaginal Fistula, sponsored by Evangel VVF Centre. Status unknown. Open to female participants. Per ClinicalTrials.gov, last updated 2017-01-24.
Sponsored by Evangel VVF Centre · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
Patients in this arm will be discharged, to return for follow up exam at 3 months postop.
Foley transurethral catheter placed to allow continuous drainage of urine.
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
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)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Vaginal Fistula