Vaginal Fistula
Conditions
Keywords
fistula, catheter, surgery, obstetrics, gynecology, urology
Brief 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.
Interventions
PROCEDURE7-day catheterization following fistula repair surgery
This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.
PROCEDURE14 day catheterization
This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.
Sponsors
World Health Organization
United States Agency for International Development (USAID)
EngenderHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Have a simple fistula, as determined at the end of fistula repair surgery (irrespective of the number of prior repair attempts and the cause of the fistula, with the exceptions noted under the
Exclusion criteria
below) * Have a closed fistula at completion of surgery * Have a closed fistula 7 days after surgery (i.e. at the time of randomization) * Understand study procedures and requirements * Agree to return to the facility for one follow-up visit three month after the date of surgery * Provide informed consent to participate in the study or in the case of non-emancipated minors, both consent to the study and receive proxy consent to participate in the study * Have no contraindications precluding their participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Intermittent catheterization due to urinary retention | 7 or 14 days post repair |
| Prolonged hospitalization | 14 or 21 days post-repair |
| Repair breakdown one week following catheter removal | 14 days or 21 days post-repair |
| Self-reported residual incontinence | 3 months |
| The occurrence of septic or febrile episodes | 14 or 21 days post-repair |
| Catheter blockage | 14 or 21 days post repair |
Countries
Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, Uganda
Outcome results
None listed