Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial.

BACKGROUND: Duration of bladder catheterisation after female genital fistula repair varies widely. We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula. METHODS: In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hospitals in the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda. Consenting patients were eligible if they had a simple fistula that was closed after surgery and remained closed 7 days after surgery, understood study procedures and requirements, and agreed to return for follow-up 3 months after surgery. We excluded women if their fistula was not simple or was radiation-induced, associated with cancer, or due to lymphogranuloma venereum; if they were pregnant; or if they had multiple fistula. A research assistant at each site randomly allocated participants 1:1 (randomly varying block sizes of 4-6; stratified by country) to 7 day or 14 day bladder catheterisation (via a random allocation sequence computer generated centrally by WHO). Outcome assessors were not masked to treatment assignment. The primary outcome was fistula repair breakdown, on the basis of dye test results, any time between 8 days after catheter removal and 3 months after surgery. The non-inferiority margin was 10%, assessed in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT01428830. FINDINGS: We randomly allocated 524 participants between March 7, 2012, and May 6, 2013; 261 in the 7 day group and 263 in the 14 day group. In the per-protocol analysis, ten (4%) of 250 patients had repair breakdown in the 7 day group (95% CI 2-8) compared with eight (3%) of 251 (2-6) in the 14 day group (risk difference 0·8% [95% CI -2·8 to 4·5]), meeting the criteria for non-inferiority. INTERPRETATION: 7 day bladder catheterisation after repair of simple fistula is non-inferior to 14 day catheterisation and could be used for management of women after repair of simple fistula with no evidence of a significantly increased risk of repair breakdown, urinary retention, or residual incontinence up to 3 months after surgery. FUNDING: US Agency for International Development.

Good clinical outcomes from a 7-year holistic programme of fistula repair in Guinea.

OBJECTIVES: Female genital fistula remains a public health concern in developing countries. From January 2007 to September 2013, the Fistula Care project, managed by EngenderHealth in partnership with the Ministry of Health and supported by USAID, integrated fistula repair services in the maternity wards of general hospitals in Guinea. The objective of this article was to present and discuss the clinical outcomes of 7 years of work involving 2116 women repaired in three hospitals across the country. METHODS: This was a retrospective cohort study using data abstracted from medical records for fistula repairs conducted from 2007 to 2013. The study data were reviewed during the period April to August 2014. RESULTS: The majority of the 2116 women who underwent surgical repair had vesicovaginal fistula (n = 2045, 97%) and 3% had rectovaginal fistula or a combination of both. Overall 1748 (83%) had a closed fistula and were continent of urine immediately after surgery. At discharge, 1795 women (85%) had a closed fistula and 1680 (79%) were dry, meaning they no longer leaked urine and/or faeces. One hundred and fifteen (5%) remained with residual incontinence despite fistula closure. Follow-up at 3 months was completed by 1663 (79%) women of whom 1405 (84.5%) had their fistula closed and 80% were continent. Twenty-one per cent were lost to follow-up. CONCLUSION: Routine programmatic repair for obstetric fistula in low resources settings can yield good outcomes. However, more efforts are needed to address loss to follow-up, sustain the results and prevent the occurrence and/or recurrence of fistula.

Assessing the quality of record keeping for cesarean deliveries: results from a multicenter retrospective record review in five low-income countries.

BACKGROUND: Reliable, timely information is the foundation of decision making for functioning health systems; the quality of decision making rests on quality data. Routine monitoring, reporting, and review of cesarean section (CS) indications, decision-to-delivery intervals, and partograph use are important elements of quality improvement for maternity services. METHODS: In 2009 and 2010, a sample of CS records from calendar year 2008 was reviewed at nine facilities in Bangladesh, Guinea, Mali, Niger, and Uganda. Data from patient records and hospital registers were collected on key aspects of care such as timing of key events, indications, partograph use, maternal and fetal outcomes. Qualitative interviews were conducted with key informants at all study sites to provide contextual background about CS services and record keeping practices. RESULTS: A total of 2,941 records were reviewed and 57 key informant interviews were conducted. Patient record-keeping systems were of varying quality across study sites: at five sites, more than 20% of records could not be located. Across all sites, patient files were missing key aspects of CS care: timing of key events (e.g., examination, decision to perform CS), administration of prophylactic antibiotics, maternal complications, and maternal and fetal outcomes. Rates of partograph use were low at six sites: 0 to 23.9% of patient files at these sites had a completed partograph on file, and among those found, 2.1% to 65.1% were completed correctly. Information on fetal outcomes was missing in up to 40% of patient files. CONCLUSIONS: Deficits in the quality of CS patient records across a broad range of health facilities in low-resource settings in four sub-Saharan Africa countries and Bangladesh indicate an urgent need to improve record keeping.

Clinical procedures and practices used in the perioperative treatment of female genital fistula during a prospective cohort study.

BACKGROUND: Treatment and care for female genital fistula have become increasingly available over the last decade in countries across Africa and South Asia. Before the International Federation of Gynaecology and Obstetrics (FIGO) and partners published a global fistula training manual in 2011 there was no internationally recognized, standardized training curriculum, including perioperative care. The community of fistula care practitioners and advocates lacks data about the prevalence of various perioperative clinical procedures and practices and their potential programmatic implications are lacking. METHODS: Data presented here are from a prospective cohort study conducted between September 2007 and September 2010 at 11 fistula repair facilities supported by Fistula Care in five countries. Clinical procedures and practices used in the routine perioperative management of over 1300 women are described. RESULTS: More than two dozen clinical procedures and practices were tabulated. Some of them were commonly used at all sites (e.g., vaginal route of repair, 95.3% of cases); others were rare (e.g., flaps/grafts, 3.4%) or varied widely depending on site (e.g. for women with urinary fistula, the inter-quartile range for median duration of post-repair bladder catheterization was 14 to 29 days). CONCLUSIONS: These findings show a wide range of clinical procedures and practices with different program implications for safety, efficacy, and cost-effectiveness. The variability indicates the need for further research so as to strengthen the evidence base for fistula treatment in developing countries.

Development and comparison of prognostic scoring systems for surgical closure of genitourinary fistula.

OBJECTIVE: The purpose of this study was to test the diagnostic performance of 5 existing classification systems (developed by Lawson, Tafesse, Goh, Waaldijk, and the World Health Organization) and a prognostic scoring system that was derived empirically from our data to predict fistula closure 3 months after surgery. STUDY DESIGN: Women with genitourinary fistula (n = 1274) who received surgical repair services at 11 health facilities in sub-Saharan Africa and Asia were enrolled in a prospective cohort study. Using one-half of the sample, we created multivariate generalized estimating equation models to obtain weighted prognostic scores for components of each existing classification system and the empirically derived scoring system. With the second one-half, we developed receiver operating characteristic curves using the prognostic scores and calculated areas under the curves (AUCs) and 95% confidence intervals (CIs) for each system. RESULTS: Among existing systems, the scoring systems that represented the World Health Organization, Goh, and Tafesse classifications had the highest predictive accuracy: AUC, 0.63 (95% CI, 0.57-0.68); AUC, 0.62 (95% CI, 0.57-0.68), and AUC, 0.60 (95% CI, 0.55-0.65), respectively. The empirically derived prognostic score achieved similar predictive accuracy (AUC, 0.62; 95% CI, 0.56-0.67); it included significant predictors of closure that are found in the other classification systems, but contained fewer, nonoverlapping components. The differences in AUCs were not statistically significant. CONCLUSION: The prognostic values of existing urinary fistula classification systems and the empirically derived score were poor to fair. Further evaluation of the validity and reliability of existing classification systems to predict fistula closure is warranted; consideration should be given to a prognostic score that is evidence-based, simple, and easy to use.

Outcomes in obstetric fistula care: a literature review.

PURPOSE OF REVIEW: To highlight the lack of consistency in the terminology and indicators related to obstetric fistula care and to put forward a call for consensus. RECENT FINDINGS: Recent studies show at least some degree of statistical correlation between outcome and the following clinical factors: degree of scarring/fibrosis, fistula location, fistula size, damage to the urethra, presence of circumferential fistula, bladder capacity, and prior attempt at fistula repair. SUMMARY: Consensus about basic definitions of clinical success does not yet exist. Opinions vary widely about the prognostic parameters for success or failure. Commonly agreed upon definitions and outcome measures will help ensure that site reviews are accurate and conducted fairly. To properly compare technical innovations with existing methods, agreement must be reached on definitions of success. Standardized indicators for mortality and morbidity associated with fistula repair will improve the evidence base and contribute to quality of care.

Factors influencing urinary fistula repair outcomes in developing countries: a systematic review.

We reviewed literature examining predictors of urinary fistula repair outcomes in developing country settings, including fistula and patient characteristics, and perioperative factors. We searched Medline for articles published between January 1970 and December 2010, excluding articles that were (1) case reports, cases series or contained 20 or fewer subjects; (2) focused on fistula in developed countries; and (3) did not include a statistical analysis of the association between facility or individual-level factors and surgical outcomes. Twenty articles were included; 17 were observational studies. Surgical outcomes included fistula closure, residual incontinence after closure, and any incontinence (dry vs wet). Scarring and urethral involvement were associated with poor prognosis across all outcomes. Results from randomized controlled trials examining prophylactic antibiotic use and repair outcomes were inconclusive. Few observational studies examining perioperative interventions accounted for confounding by fistula severity. We conclude that a unified, standardized evidence-base for informing clinical practice is lacking.

Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial.

BACKGROUND: A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. 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, 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 study will examine whether short-term (7 day) urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day) urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. METHODS/DESIGN: This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT) comparing the new proposed short-term (7 day) urethral catheterization to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. 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 for medical reasons, catheter blockage, and self-reported residual incontinence. This trial will be conducted among 512 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 24 months at each site. DISCUSSION: If no major safety issues are identified, the data from this trial may facilitate adoption of short-term urethral catheterization following repair of simple fistula in sub-Saharan Africa and Asia. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01428830.

Current practices in treatment of female genital fistula: a cross sectional study.

BACKGROUND: Maternal outcomes in most countries of the developed world are good. However, in many developing/resource-poor countries, maternal outcomes are bleaker: Every year, more than 500,000 women die in childbirth, mostly in resource-poor countries. Those who survive often suffer from severe and long-term morbidities. One of the most devastating injuries is obstetric fistula, occurring most often in south Asia and sub-Saharan Africa. Fistula treatment and care are available in many countries across Africa and Asia, but there is a lack of reliable data around clinical factors associated with the success of fistula repair surgery. Most published research has been retrospective. While these studies have provided useful information about the care and treatment of fistula, they are limited by the design. This study was designed to identify practices in care that could lead to the design of prospective and randomized controlled trials. METHODS: Self-administered questionnaires were completed by 40 surgeons known to provide fistula treatment services in Africa and Asia at private and government hospitals. The questionnaire was divided into three parts to address the following issues: prophylactic use of antibiotics before, during, and after fistula surgery; urethral catheter management; and management practices for patients with urinary incontinence following fistula repair. RESULTS: The results provide a glimpse into current practices in fistula treatment and care across a wide swath of geographic, economic, and organizational considerations. There is consensus in treatment in some areas (routine use of prophylactic antibiotics, limited bed rest until the catheter is removed, nonsurgical treatment for postsurgical incontinence), while there are wide variations in practice in other areas (duration of catheter use, surgical treatments for postsurgical incontinence). These findings are based on a small sample and do not allow for recommending changes in clinical care, but they point to issues for possible clinical trial research that would contribute to more efficient and effective fistula care. CONCLUSIONS: The findings from the survey allowed us to consider clinical practices most influential in the cost, efficacy, and safety of fistula treatment. These considerations led us to formulate recommendations for eight randomized controlled trials on the following subjects: 1) Efficacy/safety of short-term catheterization; 2) efficacy of surgical and nonsurgical therapies for urinary incontinence; 3) technical measures during fistula repair to reduce the incidence of post-surgery incontinence; 4) identification of predictive factors for "incurable fistula"; 5) usefulness of urodynamic studies in the management of urinary incontinence; 6) incidence and significance of multi-drug resistant bacteria in the fistula population; 7) primary management of small, new fistulas by catheter drainage; and 8) antibiotic prophylaxis in fistula repair.

Fistula and traumatic genital injury from sexual violence in a conflict setting in Eastern Congo: case studies.

The Eastern region of the Democratic Republic of Congo (DRC) is currently undergoing a brutal war. Armed groups from the DRC and neighbouring countries are committing atrocities and systematically using sexual violence as a weapon of war to humiliate, intimidate and dominate women, girls, their men and communities. Armed combatants take advantage with impunity, knowing they will not be held to account or pursued by police or judicial authorities. A particularly inhumane public health problem has emerged: traumatic gynaecological fistula and genital injury from brutal sexual violence and gang-rape, along with enormous psychosocial and emotional burdens. Many of the women who survive find themselves pregnant or infected with STIs/HIV with no access to treatment. This report was compiled at the Doctors on Call for Service/Heal Africa Hospital in Goma, Eastern Congo, from the cases of 4,715 women and girls who suffered sexual violence between April 2003 and June 2006, of whom 702 had genital fistula. It presents the personal experiences of seven survivors whose injuries were severe and long-term, with life-changing effects. The paper recommends a coordinated effort amongst key stakeholders to secure peace and stability, an increase in humanitarian assistance and the rebuilding of the infrastructure, human and physical resources, and medical, educational and judicial systems.