Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures

NCT ID: NCT03029130

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-03-31

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.

Conditions

Vesico Vaginal Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Catheter Extension

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.

Group Type: EXPERIMENTAL

Catheter extension

Intervention Type: DEVICE

Foley transurethral catheter placed to allow continuous drainage of urine.

Discharge

Patients in this arm will be discharged, to return for follow up exam at 3 months postop.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Catheter extension

Foley transurethral catheter placed to allow continuous drainage of urine.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Evangel VVF Centre

OTHER

Sponsor Role: lead

Responsible Party

Steven Shephard

Fistula Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EvangelWFC

Identifier Type: -

Identifier Source: org_study_id