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.

Factors associated with the failure of obstetric fistula repair in Guinea: implications for practice.

BACKGROUND: The prevention and treatment of obstetric fistula still remains a concern and a challenge in low income countries. The objective of this study was to estimate the overall proportions of failure of fistula closure and incontinence among women undergoing repair for obstetric fistula in Guinea and identify its associated factors. METHODS: This was a retrospective cohort study using data extracted from medical records of fistula repairs between 1 January 2012 and 30 September 2013. The outcome was the failure of fistula closure and incontinence at hospital discharge evaluated by a dye test. A sub-sample of women with vesicovaginal fistula was used to identify the factors associated with these outcomes. RESULTS: Overall, 109 women out of 754 (14.5 %; 95 % CI:11.9-17.0) unsuccessful repaired fistula at discharge and 132 (17.5 %; 95 % CI:14.8-20.2) were not continent. Failure of fistula closure was associated with vaginal delivery (AOR: 1.9; 95 % CI: 1.0-3.6), partially (AOR: 2.0; 95 % CI: 1.1-5.6) or totally damaged urethra (AOR: 5.9; 95 % CI: 2.9-12.3) and surgical repair at Jean Paul II Hospital (AOR: 2.5; 95 % CI: 1.2-4.9). Women who had a partially damaged urethra (AOR: 2.5; 95 % CI: 1.5-4.4) or a totally damaged urethra (AOR: 6.3; 95 % CI: 3.0-13.0) were more likely to experience post-repair urinary incontinence than women who had their urethra intact. CONCLUSION: At programmatic level in Guinea, caution should be paid to the repair of women who present with a damaged urethra and those who delivered vaginally as they carry greater risks of experiencing a failure of fistula closure and incontinence.

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.

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.

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.

Social Immersion for Women After Repair for Obstetric Fistula: An Experience in Guinea.

Background: Reintegration of women after repair of their female genital fistula remains a challenge. The objective of this study was to document the medical pathway and the reintegration process of women through the "social immersion" program of EngenderHealth in Kissidougou and Labé (Guinea). Methods: This was a qualitative descriptive study with 55 participants, including women seeking fistula care and stakeholders involved in the social immersion for repaired women in Kissidougou and Labé. The study included collecting demographic and clinical data of women, interviews with women before and after surgery, after social immersion, and 3 months post-discharge. Municipal officials, health providers, and members of host families were also interviewed. The study protocol was approved by the Guinea National Ethics Committee for Health Research. Results: The study confirmed that obstetric fistula still occurs among women living in rural and underserved areas. Most women attended at least two to five antenatal care visits, but nine over 10 reported a tragic experience of child loss associated with the occurrence of fistula. Most of them received support from their husband/partner during referral after the obstructed labor and later in the search for treatment. Women and stakeholders reported a good experience of surgery and social immersion in both Kissidougou and Labé. About 3 months after discharge, women who were continent reported being happy with their new life compared to women discharged with repair failure and residual incontinence. Conclusion: The study found the positive impacts of social immersion on the quality of life of women after fistula repair, particularly for those women who had a successful repair. The approach can be included in fistula care programs, either through direct provision or through referral to programs that can provide this service.

How Has the Free Obstetric Care Policy Impacted Unmet Obstetric Need in a Rural Health District in Guinea?

INTRODUCTION: In 2010, the Ministry of Health (MoH) of Guinea introduced a free emergency obstetric care policy in all the public health facilities of the country. This included antenatal checks, normal delivery and Caesarean section. OBJECTIVE: This study aims at assessing the changes in coverage of obstetric care according to the Unmet Obstetric Need concept before (2008) and after (2012) the implementation of the free emergency obstetric care policy in a rural health district in Guinea. METHODS: We carried out a descriptive cross-sectional study involving the retrospective review of routine programme data during the period April to June 2014. RESULTS: No statistical difference was observed in women's sociodemographic characteristics and indications (absolute maternal indications versus non-absolute maternal indications) before and after the implementation of the policy. Compared to referrals from health centers of patients, direct admissions at hospital significantly increased from 49% to 66% between 2008 and 2012 (p = 0.001). In rural areas, this increase concerned all maternal complications regardless of their severity, while in urban areas it mainly affected very severe complications. Compared to 2008, there were significantly more Major Obstetric Interventions for Maternal Absolute Indications in 2012 (p < 0.001). Maternal deaths decreased between 2008 and 2012 from 1.5% to 1.1% while neonatal death increased from 12% in 2008 to 15% in 2012. CONCLUSION: The implementation of the free obstetric care policy led to a significant decrease in unmet obstetric need between 2008 and 2012 in the health district of Kissidougou. However, more research is needed to allow comparisons with other health districts in the country and to analyse the trends.

Profiles and experiences of women undergoing genital fistula repair: findings from five countries.

This article presents data from 1354 women from five countries who participated in a prospective cohort study conducted between 2007 and 2010. Women undergoing surgery for fistula repair were interviewed at the time of admission, discharge, and at a 3-month follow-up visit. While women's experiences differed across countries, a similar picture emerges across countries: women married young, most were married at the time of admission, had little education, and for many, the fistula occurred after the first pregnancy. Median age at the time of fistula occurrence was 20.0 years (interquartile range 17.3-26.8). Half of the women attended some antenatal care (ANC); among those who attended ANC, less than 50% recalled being told about signs of pregnancy complications. At follow-up, most women (even those who were not dry) reported improvements in many aspects of social life, however, reported improvements varied by repair outcome. Prevention and treatment programmes need to recognise the supportive role that husbands, partners, and families play as women prepare for safe delivery. Effective treatment and support programmes are needed for women who remain incontinent after surgery.

Determinants of postoperative outcomes of female genital fistula repair surgery.

OBJECTIVE: To determine predictors of fistula repair outcomes 3 months postsurgery. METHODS: We conducted a multicountry prospective cohort study between 2007 and 2010. Outcomes, measured 3 months postsurgery, included fistula closure and residual incontinence in women with a closed fistula. Potential predictors included patient and fistula characteristics and context of repair. Multivariable generalized estimating equation models were used to generate adjusted risk ratios (RRs) and 95% confidence intervals (CIs). RESULTS: Women who returned for follow-up 3-month postsurgery were included in predictors of closure analyses (n=1,274). Small bladder size (adjusted RR 1.57, 95% CI 1.39-1.79), prior repair (adjusted RR 1.40, 95% CI 1.11-1.76), severe vaginal scarring (adjusted RR 1.56, 95% CI 1.20-2.04), partial urethral involvement (adjusted RR 1.36, 95% CI 1.11-1.66), and complete urethral destruction or circumferential defect (adjusted RR 1.72, 95% CI 1.33-2.23) predicted failed fistula closure. Women with a closed fistula at 3-month follow-up were included in predictors of residual incontinence analyses (n=1,041). Prior repair (adjusted RR 1.37, 95% CI 1.13-1.65), severe vaginal scarring (adjusted RR 1.35, 95% CI 1.10-1.67), partial urethral involvement (adjusted RR 1.78, 95% CI 1.27-2.48), and complete urethral destruction or circumferential defect (adjusted RR 2.06, 95% CI 1.51-2.81) were significantly associated with residual incontinence. CONCLUSION: The prognosis for genital fistula closure is related to preoperative bladder size, previous repair, vaginal scarring, and urethral involvement.