An interventional study of 7-day catheterization following fistula repair surgery and 14 day catheterization in Vaginal Fistula, sponsored by EngenderHealth. Completed at 8 sites in 8 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2015-01-19.
Sponsored by EngenderHealth · Not applicable, Interventional, and Treatment
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.
219 studies on the registry are indexed under Fistula; 49 are open to participants now.
This study's enrollment of 524 is above the median of 50 across 152 interventional studies indexed under Fistula.
Browse Fistula studies →EngenderHealth is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: 7-day catheterization following fistula repair surgery
Procedure: 14 day catheterization
This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.
This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.
Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test.
Time frame: 3 months
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
The record gives a start of Jan 2012, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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