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| Name | Class |
|---|---|
| World Health Organization | OTHER |
| United States Agency for International Development (USAID) | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7-day catheterization | Experimental |
| |
| 14-day catheterization | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7-day catheterization following fistula repair surgery | Procedure | This group will have an indwelling urethral catheter for 7 days following fistula repair surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Repair breakdown one week following catheter removal | 14 days or 21 days post-repair | |
| Intermittent catheterization due to urinary retention | 7 or 14 days post repair | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Barone, DVM, MS | EngenderHealth | Principal Investigator |
| Mariana Widmer | World Health Organization | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Joseph | Kinshasa | Democratic Republic of the Congo | ||||
| Gondar University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25911172 | Derived | Barone MA, Widmer M, Arrowsmith S, Ruminjo J, Seuc A, Landry E, Barry TH, Danladi D, Djangnikpo L, Gbawuru-Mansaray T, Harou I, Lewis A, Muleta M, Nembunzu D, Olupot R, Sunday-Adeoye I, Wakasiaka WK, Landoulsi S, Delamou A, Were L, Frajzyngier V, Beattie K, Gulmezoglu AM. Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial. Lancet. 2015 Jul 4;386(9988):56-62. doi: 10.1016/S0140-6736(14)62337-0. Epub 2015 Apr 21. | |
| 22433581 |
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| ID | Term |
|---|---|
| D014624 | Vaginal Fistula |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002404 | Catheterization |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| 14 day catheterization | Procedure | This group will have an indwelling urethral catheter for 14 days following fistula repair surgery. |
|
| Prolonged hospitalization |
| 14 or 21 days post-repair |
| Catheter blockage | 14 or 21 days post repair |
| Self-reported residual incontinence | 3 months |
| The occurrence of septic or febrile episodes | 14 or 21 days post-repair |
| Gonder |
| Ethiopia |
| L'Hôpital Préfectoral de Kissidougou | Kissidougou | Guinea |
| Kenyatta National Hospital | Nairobi | Kenya |
| National Obstetric Fistula Centre | Abakaliki | Nigeria |
| Maternité Centrale de Zinder | Zinder | Niger |
| Aberdeen Women's Centre | Freetown | Sierra Leone |
| Kagando Hospital | Kasese District | Uganda |
| Derived |
| Barone MA, Frajzyngier V, Arrowsmith S, Ruminjo J, Seuc A, Landry E, Beattie K, Barry TH, Lewis A, Muleta M, Nembunzu D, Olupot R, Sunday-Adeoye I, Wakasiaka WK, Widmer M, Gulmezoglu AM. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial. BMC Womens Health. 2012 Mar 20;12:5. doi: 10.1186/1472-6874-12-5. |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |