Research

• Ongoing Research

• Completed Research

Ongoing Research

Randomized Controlled Trial on Short-Term Catheterization

RCT Online Resource Center (RCT partners only)

Fistula Care and the World Health Organization are collaborating on a randomized controlled trial to assess the efficacy and safety of using short-term catheterization after fistula repair rather than longer-term catheterization. To our knowledge, this is the first multi-center randomized controlled trial about treatment of vesico-vaginal fistula conducted in multiple African countries, making it a major milestone study for the advancement of best practices for fistula treatment. Short-term catheterization has the potential to reduce hospital stays for women, decrease post-surgery complications, free up bed space at facilities, and lower costs, potentially allowing more women to receive clinical care.

The study launched in December 2011. Eight facilities across eight African countries (Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda) are participating and contributing data. A total of 507 women are expected to be enrolled in the study. The study protocol was published in BMC Women's Health in March 2012.

Completed Research

Piloting a Community Screening Model for Fistula in Nigeria

Guinea Levels of Fistula Care Evaluation

In 2011 we conducted a two part in-depth evaluation of the Guinea program to examine the supply side of the program and the community-level fistula prevention efforts. The supply side evaluation was carried out to determine the readiness of supported sites to provide fistula treatment and prevention care.  The community evaluation was undertaken to explore whether the establishment and support of the Village Safe Motherhood Committees in the intervention areas had led to measurable outputs in terms of enhanced community capacities and social capital related to maternal health, as well as whether enhanced community capacity and social capital were associated with outcomes, such as fistula prevention knowledge, birth preparedness and maternity care-seeking at the population. The study methodology included facility assessments, a community survey, and key informant interviews. Final reports are expected in early 2013.

Determinants of Post-Operative Outcomes in Fistula Repair Surgery

What patient attributes, fistula characteristics, and operative techniques influence the success of fistula repair surgery? In consultation with USAID, Fistula Care carried out the study "Determinants of Post-Operative Outcomes in Fistula Repair Surgery" in order to answer pressing clinical research questions and inform future interventions and further research. The study was conducted at 11 facilities in five countries: Bangladesh, Guinea, Niger, Nigeria, and Uganda.

A total of 1,450 women were enrolled in the study between 2007 and 2010. The primary objective was to determine predictors of complications and success of fistula repair surgery and the secondary to examine the social and structural factors associated with fistula.

Data collected through the study have resulted, thus far, in four scientific publications:

• Development and Comparison of Prognostic Scoring Systems for Surgical Closure of Genitourinary Fistula
  Published in February 2013 in the American Journal of Obstetrics and Gynecology, this paper tests the diagnostic performance of five existing classification systems and a prognostic scoring system that was derived empirically from prospective data to predict fistula closure three months after surgery.

• Determinants of Post-Operative Outcomes in Fistula Repair Surgery: A Prospective Cohort Study
  This paper, published in 2012 in Obstetrics and Gynecology, discusses how preoperative bladder size, a history of prior repair attempts, and the degree of vaginal scarring and urethral involvement are all characteristics that can affect the prognosis for fistula repair. To read the abstract in French, click here.

• Factors Influencing Choice of Surgical Route of Repair of Urinary Fistula, and the Influence of Route of Repair on Surgical Outcomes: Findings from a Prospective Cohort Study
  Published in 2012 in the British Journal of Obstetrics and Gynecology, this paper shows that using a vaginal route for surgical fistula repair was associated with increased risk of failed fistula closure. While reasons for this remain unclear, the analyses suggest that the risk of failed fistula closure among women repaired vaginally was particularly elevated for those women who met indications for an abdominal repair. To read the abstract in French, click here.
• Factors Influencing Fistula Repair Outcomes in Developing Countries: A Systematic Review
  The results of this systematic review, published in 2012 in the American Journal of Obstetrics and Gynecology, finds an insufficient evidence base in the scientific literature on the predictors of fistula repair outcomes, and thus little published evidence to inform clinical practices. To read the abstract in French, click here.

Current Practices in Treatment of Female Genital Fistula: A Cross-Sectional Study

In 2009, 40 surgeons who provide fistula treatment services in Africa and Asia at private and government hospitals completed questionnaires. The questionnaire addressed three 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.

The results, published in 2010 in BMC Pregnancy and Childbirth, provide a snapshot of current practices in fistula treatment and care. There is consensus in treatment in some areas 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 research that would contribute to more efficient and effective fistula care.

Assessing the Costs of Fistula Treatment Services

Fistula Care collaborated with selected sites to undertake a study to determine the cost of fistula repair services. The study was intended to assist fistula repair sites to identify, allocate and manage resources for the provision of quality fistula care services. Findings, analysis, and implications were discussed with the site, local and national authorities, including the National Fistula Working Groups or Ministries of Health. The results will facilitate improved coordination with other donors and provide standardization in the approach to calculating the costs of fistula surgery. Data collection was undertaken at sites in Ethiopia and Nigeria. A summary of the findings will be available soon.

Multi-Center Retrospective Record Review of Data Collection Procedures and Data Quality of Indications for Cesarean Deliveries

Obstructed labor is a major cause of maternal and neonatal mortality and morbidities, including obstetric fistula. Quality and timely cesarean delivery services can ease the obstruction and prevent fistula. Although data is available about cesarean rates, little data is available about the factors that lead clinical staff to recommend cesarean sections. This record review sought to determine the leading indications for cesarean delivery. Results from this study will help facilities to better understand and document cesarean section indications.

Data collection was completed in 2010 at 11 facilities which receive support from Fistula Care in five countries (Bangladesh, Guinea, Niger, Nigeria, Uganda). In total 2,941 ceasaren delivery records from 2008 were randomly selected and reviewed. Study findings have been disseminated at each study site and a comprehensive report of the aggregate results is being prepared.