An interventional study of 7-day catheterization following fistula repair surgery and 14 day catheterization in Vaginal Fistula, sponsored by EngenderHealth. Completed at 8 sites in 8 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2015-01-19.
Sponsored by EngenderHealth · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Procedure: 7-day catheterization following fistula repair surgery
Procedure: 14 day catheterization
This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.
This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.
Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test.
Time frame: 3 months
Repair breakdown one week following catheter removal
Time frame: 14 days or 21 days post-repair
Intermittent catheterization due to urinary retention
Time frame: 7 or 14 days post repair
Prolonged hospitalization
Time frame: 14 or 21 days post-repair
Catheter blockage
Time frame: 14 or 21 days post repair
Self-reported residual incontinence
Time frame: 3 months
The occurrence of septic or febrile episodes
Time frame: 14 or 21 days post-repair
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Vaginal Fistula
EngenderHealth