Abstract
BackgroundA vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. 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, 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 study will examine whether short-term (7 day) urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day) urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service.Methods/DesignThis study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT) comparing the new proposed short-term (7 day) urethral catheterization to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. 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 for medical reasons, catheter blockage, and self-reported residual incontinence. This trial will be conducted among 512 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 24 months at each site.DiscussionIf no major safety issues are identified, the data from this trial may facilitate adoption of short-term urethral catheterization following repair of simple fistula in sub-Saharan Africa and Asia.Trial registrationClinicalTrials.gov Identifier NCT01428830.
Highlights
A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia
While biologic scaffolds composed of extracellular matrix (ECM) are a cutting edge innovation not feasible for fistula repair in developing countries, these results suggest that removing the catheter early and allowing the bladder to begin filling and emptying, may be beneficial, rather than harmful, to bladder healing
Nardos and colleagues calculated the implications of urethral catheterization duration at the Addis Ababa Fistula Hospital, where approximately 1200 fistula repairs are performed annually
Summary
A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcareassociated infections among fistula patients. The prolonged bladder catheterization that is frequently employed after surgery translates into a need for longer hospitalization, more intensive nursing care, and increased costs, leading to decreased capacity for treating other patients. Reducing the duration of bladder catheterization, provided no compromise in surgical outcomes and patient health, has important implications for the delivery of fistula care and treatment services in low resource settings
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
