Overview

This trial is active, not recruiting.

Condition vaginal fistula
Treatments 7-day catheterization following fistula repair surgery, 14 day catheterization
Sponsor EngenderHealth
Collaborator World Health Organization
Start date January 2012
End date June 2013
Trial size 507 participants
Trial identifier NCT01428830, A65783

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
7-day catheterization following fistula repair surgery
This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.
(Active Comparator)
14 day catheterization
This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.

Primary Outcomes

Measure
Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test.
time frame: 3 months

Secondary Outcomes

Measure
Repair breakdown one week following catheter removal
time frame: 14 days or 21 days post-repair
Intermittent catheterization due to urinary retention
time frame: 7 or 14 days post repair
Prolonged hospitalization
time frame: 14 or 21 days post-repair
Catheter blockage
time frame: 14 or 21 days post repair
Self-reported residual incontinence
time frame: 3 months
The occurrence of septic or febrile episodes
time frame: 14 or 21 days post-repair

Eligibility Criteria

Female participants of any age.

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. Exclusion Criteria: - Have a fistula that is determined to be "not simple" (i.e. intermediate or complex) - Have a fistula that is radiation-induced, associated with cancer or due to lymphogranuloma venereum (These cases will be excluded because the healing process is very different from fistula resulting from other causes. We expect there to be few cases of these fistulas at the study sites) - Have a fistula that is not closed immediately after surgery or 7 days after surgery (i.e. at the time of randomization)

Additional Information

Official title Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery
Principal investigator Mark A Barone, DVM, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by EngenderHealth.