Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

This 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.If 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.ClinicalTrials.gov Identifier NCT01428830.A vaginal fistula is a devastating condition, and while true prevalence is unknown, it is estimated to affect 2 million girls and women across Africa and Asia. The primary cause of a vaginal fistula is prolonged obstructed labor: the fetus's head compresses the soft tissues of the bladder, vagina and rectum against the woman's pelvis, cutting off blood supply to the tissue, causing the tissue to die and slough away. The result is an abnormal opening between the vagina and bladder, or between the vagina and rectum, or both, and either urinary and/or fecal incontinence.Approximately 80-95% of vaginal fistula can be closed surgically [1]; however, the provision of fistula repair services in developing countries is not without challenges. Specialized training and skills are necessary, especially to handle more complex cases, and this limits the availability of services. Women with fistula are pr