NCT01428830

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 524 (actual)
• Sponsor: EngenderHealth · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Vaginal Fistula

Interventions

Type	Name	Description
PROCEDURE	7-day catheterization following fistula repair surgery	This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.
PROCEDURE	14 day catheterization	This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-09-05
• Last updated: 2015-01-19

Locations

8 sites across 8 countries: Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Nigeria, Niger, Sierra Leone, Uganda