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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03029130
Study type Interventional
Source Evangel VVF Centre
Contact
Status Enrolling by invitation
Phase N/A
Start date January 1, 2017
Completion date March 31, 2020

See also
  Status Clinical Trial Phase
Completed NCT04676568 - Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula N/A
Recruiting NCT03414060 - Feasibility of the Menstrual Cup for VVF N/A