Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

524 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-08-31

Brief Summary

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This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown three months following urinary fistula repair surgery. The study will be conducted among 507 women with simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.

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Detailed Description

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A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity (by freeing available bed space and increasing availability of nursing staff), lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery.

This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test, a routine practice in fistula repair services. t. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization (defined as a stay at the facility beyond one week following initial catheter removal related to an adverse event), catheter blockage, and self-reported residual incontinence. This study will be conducted among 507 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 16-18 months at each site.

Conditions

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Vaginal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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7-day catheterization

Group Type EXPERIMENTAL

7-day catheterization following fistula repair surgery

Intervention Type PROCEDURE

This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.

14-day catheterization

Group Type ACTIVE_COMPARATOR

14 day catheterization

Intervention Type PROCEDURE

This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.

Interventions

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7-day catheterization following fistula repair surgery

This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.

Intervention Type PROCEDURE

14 day catheterization

This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

* Have a closed fistula at completion of surgery
* Have a closed fistula 7 days after surgery (i.e. at the time of randomization)
* Understand study procedures and requirements
* Agree to return to the facility for one follow-up visit three month after the date of surgery
* Provide informed consent to participate in the study or in the case of non-emancipated minors, both consent to the study and receive proxy consent to participate in the study
* Have no contraindications precluding their participation.

* Have a fistula that is determined to be "not simple" (i.e. intermediate or complex)
* Have a fistula that is radiation-induced, associated with cancer or due to lymphogranuloma venereum (These cases will be excluded because the healing process is very different from fistula resulting from other causes. We expect there to be few cases of these fistulas at the study sites)
* Have a fistula that is not closed immediately after surgery or 7 days after surgery (i.e. at the time of randomization)

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No