Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures

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

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.

Study Overview

• Status: Unknown
• Conditions: Vesico Vaginal Fistula
• Intervention / Treatment: Device: Catheter extension

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.

• Study Type: Interventional
• Enrollment (Anticipated): 232
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Evangel VVF Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 24, 2017

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: urinary catheter; vesicovaginal fistula; catheter extension
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urogenital Abnormalities; Pathological Conditions, Anatomical; Vaginal Diseases; Urinary Bladder Fistula; Urinary Fistula; Fistula; Vaginal Fistula; Vesicovaginal Fistula
• Other Study ID Numbers: EvangelWFC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No