Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures

Vesico Vaginal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03029130
• Other study ID #: EvangelWFC
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 20, 2017
• Last updated: January 23, 2017
• Start date: January 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: January 2017
• Source: Evangel VVF Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 232
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Vaginal Fistula
• Vesico Vaginal Fistula
• Vesicovaginal Fistula

Intervention

Device:
• Catheter extension
Foley transurethral catheter placed to allow continuous drainage of urine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Evangel VVF Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Urinary continence	Patient is completely continent of urine with no reported OR demonstrable leakage of dye on inspection.	3 months post-repair
Secondary	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)
Secondary	Complications	Rates of complications or urinary tract infections during hospitalization	Duration of hospitalization (minimum 7 days, maximum 28 days post-repair)