Training and capacity building in obstetric fistula repair: A scoping review.

BACKGROUND: An ongoing barrier to sustainable obstetric fistula (OF) care is the lack of trained fistula surgeons. Despite a standardized training curriculum, data regarding OF repair training remain limited. OBJECTIVES: To assess the availability of literature on the case numbers or training duration required for OF repair competency and whether these data are stratified by trainee background or repair complexity. SEARCH STRATEGY: A systematic search of MEDLINE, Embase, and OVID Global Health electronic databases and gray literature. SELECTION CRITERIA: All English sources from all years from low- and middle-income and high-income countries were eligible. Identified titles and abstracts were screened and full-text articles were reviewed. DATA COLLECTION AND ANALYSIS: Data collection and analysis included a descriptive summary organized by training case numbers, training duration, trainee background, and repair complexity. RESULTS: Of the 405 sources retrieved, 24 were included in the study. The only concrete recommendations were in the International Federation of Gynecology and Obstetrics 2022 Fistula Surgery Training Manual, which proposes 50 to 100 repairs (Level 1), 200 to 300 repairs (Level 2), and trainer discretion for Level 3 competency. CONCLUSIONS: More case- or time-based data, particularly if stratified by trainee background and repair complexity, would be useful at the individual, institutional, and policy level for fistula care implementation or expansion.

Urinary diversion for patients with inoperable obstetric vesicovaginal fistula: the Jos, Nigeria experience.

INTRODUCTION: Repair of obstetric urinary fistula may result in successful fistula closure, but often incontinence persists. Our goal was to review our experience with continent urinary diversion in our patients with inoperable vesicovaginal fistula (VVF). METHODS: The database of patients who underwent urinary diversion at ECWA Evangel VVF Centre in Jos, Nigeria, between 1996 and 2012, was reviewed. Complications and surgical outcomes were noted. The earlier patients (1996-2002) and the later patients (2003-2012) were compared. RESULTS: Urinary diversions were performed on 118 patients. Compared with the earlier patients, the later patients more often underwent modified Mainz II diversions, had similar complication rates, but had better outcomes. The use of ureteric catheters intraoperatively and the performance of modified Mainz II pouch were associated with a better outcome. Overall perioperative mortality was 2.5 %. CONCLUSIONS: Urinary diversion is feasible in a low-resource setting. Use of modified Mainz II pouch diversion and intraoperative ureteric catheters were associated with a better outcome. Urinary diversion should be undertaken only after the careful counseling of each patient, and by an experienced surgeon.

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.

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.

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.

Obstetric fistula: the ECWA Evangel VVF Center surgical experience from Jos, Nigeria.

INTRODUCTION AND HYPOTHESIS: The objectives of this study are to analyze the surgical outcomes of women undergoing obstetric fistula repair operations at the ECWA Evangel VVF Center, Jos, Nigeria, and to identify factors associated with postoperative urinary continence. METHODS: Sociodemographic and clinical data were abstracted retrospectively from the Center's database for patients who underwent vesicovaginal fistula (VVF) repair operations. These data were compared with clinical outcome ("wet" or "dry") at the time of hospital discharge. RESULTS: From August 1998 to April 2004, 1,084 fistula repair operations were performed on 926 patients. A vaginal approach was used in 90.1% of cases, and postsurgical continence was achieved in 70.5% of patients. Continence was more likely in patients with an intact urethra, an upper or midvaginal fistula, and less fibrosis than in those patients who remained wet. CONCLUSIONS: Two thirds of patients with obstetric fistulas can be cured, with complete restoration of continence and low surgical morbidity, using a transvaginal surgical approach.

Ethical aspects of urinary diversion for women with irreparable obstetric fistulas in developing countries.

Obstetric fistula formation is a catastrophic complication of prolonged obstructed labor. Obstetric fistulas are common in impoverished countries where access to maternal health care is poor. Although most fistulas can be closed successfully at the time of operation, a small number of women sustain such extensive pelvic injuries that their fistulas are irreparable. Some Western surgeons visiting African countries where fistulas are prevalent have become enthusiastic advocates of performing urinary diversions on these women, transplanting the ureters into the colon. We present a case study of one such woman with an irreparable obstetric fistula and discuss the complex ethical issues involved in considering whether to offer operations of this kind to African fistula victims.

A code of ethics for the fistula surgeon.

Vesicovaginal fistulas from obstructed labor no longer exist in wealthy industrialized countries. In the impoverished countries of sub-Saharan Africa and south Asia obstetric fistulas continue to be a prevalent clinical problem. As many as 3.5 million women may suffer from this condition and few centers exist that can provide them with competent and compassionate surgical repair of their injuries. As this situation has become more widely known in the industrialized world, increasing numbers of surgeons have begun traveling to poor countries to perform fistula operations. To date, these efforts have been carried out largely by well-intentioned individuals, acting alone. An international community of fistula surgeons who share common goals and values is still in the process of being created. To help facilitate the development of a common ethos and to improve the quality of care afforded to women suffering from obstetric fistulas, we propose a Code of Ethics for fistula surgeons that embraces the fundamental principles of beneficence, non-maleficence, respect for personal autonomy, and a dedication to the pursuit of justice.

Humanitarian ventures or 'fistula tourism?': the ethical perils of pelvic surgery in the developing world.

The vesico-vaginal fistula from prolonged obstructed labor has become a rarity in the industrialized West but still continues to afflict millions of women in impoverished Third World countries. As awareness of this problem has grown more widespread, increasing numbers of American and European surgeons are volunteering to go on short-term medical mission trips to perform fistula repair operations in African and Asian countries. Although motivated by genuine humanitarian concerns, such projects may serve to promote 'fistula tourism' rather than significant improvements in the medical infrastructure of the countries where these problems exist. This article raises practical and ethical questions that ought to be asked about 'fistula trips' of this kind, and suggests strategies to help insure that unintended harm does not result from such projects. The importance of accurate data collection, thoughtful study design, critical ethical oversight, logistical and financial support systems, and the importance of nurturing local capacity are stressed. The most critical elements in the development of successful programs for treating obstetric vesico-vaginal fistulas are a commitment to developing holistic approaches that meet the multifaceted needs of the fistula victim and identifying and supporting a 'fistula champion' who can provide passionate advocacy for these women at the local level to sustain the momentum necessary to make long-term success a reality for such programs.

The obstetric vesicovaginal fistula: characteristics of 899 patients from Jos, Nigeria.

OBJECTIVE: The purpose of this study was to describe the characteristics of women with obstetric vesicovaginal fistulas at a hospital in north central Nigeria. STUDY DESIGN: A retrospective record review was conducted of all women who were seen with vesicovaginal fistulas at Evangel Hospital in Jos, Plateau State, Nigeria, between January 1992 and June 1999. RESULTS: A total of 932 fistula cases were identified, of which 899 cases (96.5%) were associated temporally with labor and delivery. The "typical patient" was small and short (44 kg and <150 cm); had been married early (15.5 years) but was now divorced or separated; was uneducated, poor, and from a rural area; had developed her fistula as a primigravida during a labor that lasted at least 2 days and which resulted in a stillborn fetus. CONCLUSION: Obstetric vesicovaginal fistula is extremely common in north central Nigeria. A complex interaction that involves multiple biologic and socioeconomic factors appears to predispose young women to this devastating childbirth injury.