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

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.

Good clinical outcomes from a 7‐year holistic programme of fistula repair in Guinea

“…We observed a high closure rate at discharge (85%) and at 3 months of follow‐up (84.5%), similar to what was reported in other studies in African settings []. The continence rate was 79% at discharge and 80% at 3 months of follow‐up, which falls within the range reported by Arrowsmith et al .…”

“… at 6 months (39.5%). However, some of the women in our study (17%) were part of either a prospective cohort study or a randomised controlled trial conducted at one of the sites, which used specific proactive strategies to reduce loss to follow‐up , thus potentially causing an artificial inflation of our follow‐up rate.…”

Predictors of Time to Recovery from a Surgical Repair of Obstetric Fistula at Mekelle Hamlin Fistula Center, Tigray, Ethiopia

“…Moreover, continuous bladder drainage through folly catheter helps the bladder repair to heal without distension and reduces the risk of infection, breakdown of repair and patient's hospital stay. Since recovery after surgery generally takes two weeks, patient's bladder needs drainage through a catheter traditionally for two weeks [32,46,47]. This is also in agreement with the findings of a multi country study that has involved patients from 11 study sites in Uganda, Guinea, Niger, Nigeria and Bangladesh which dictate's duration of catheterization for 14 days and more was associated with failure to close the Fistula compared to women catheterized for less than 14 days [32,48].…”

Transvaginal genital fistula repair with insertion of Foley catheter via fistula tract

“…Barone et al and Nardos et al, however, found that a short duration of catheterization of approximately 7 days or 10 days is not inferior to that of longterm catheterization. 18,19 Short-term catheterization ensures shorter postoperative hospitalization, and lower infectious morbidity, and lessens the financial burden of patients. In the present study, all patients maintained urethral catheterization for 10 days after the surgery.…”