Vaginal Fistula Clinical Trial
Official title:
Non-inferiority of Short-term 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 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01864473 -
Management of Vaginal Fistula by Kshar Sutra, a Minimally Invasive Treatment
|
N/A | |
| Recruiting |
NCT03414060 -
Feasibility of the Menstrual Cup for VVF
|
N/A |