Factors Associated With Persistent Urinary Incontinence Among Women Undergoing Female Genital Fistula Surgery in the Democratic Republic of Congo From 2017 to 2019.

Background: Despite high closure rates, residual urinary incontinence remains a common problem after successful closure of a vesico-vaginal fistula. The objective of this study was to identify factors associated with residual urinary incontinence in women with successful fistula closure in sites supported by the Fistula Care Plus project in the Democratic Republic of Congo (DRC). Material and Methods: This was a retrospective cohort study using routine data extracted from the medical records of women undergoing fistula surgery in three hospitals supported by the Fistula Care Plus project in DRC between 2017 and 2019. We analyzed factors associated with residual urinary incontinence among a subsample of women with closed fistula at discharge. We collected data on sociodemographic, clinical, gynecological-obstetrical characteristics, and case management. Univariate and multivariate analyses were performed to determine the factors associated with residual urinary incontinence. Results: Overall, 31 of 718 women discharged with closed fistula after repair (4.3%; 95% CI: 3.1-6.1) had residual incontinence. The leading causes identified in these women with residual incontinence were urethral voiding (6 women), short urethra (6 women), severe fibrosis (3 women) and micro-bladder (2 women). The prevalence of residual incontinence was higher among women who received repair at the Heal Africa (6.6%) and St Joseph's (3.7%) sites compared with the Panzi site (1.7%). Factors associated with increased odds of persistent urinary incontinence were the Heal Africa repair site (aOR: 54.18; 95% CI: 5.33-550.89), any previous surgeries (aOR: 3.17; 95% CI: 1.10-9.14) and vaginal surgical route (aOR: 6.78; 95% CI: 1.02-45.21). Conclusion: Prior surgery and repair sites were the main predictors of residual incontinence after fistula closure. Early detection and management of urinary incontinence and further research to understand site contribution to persistent incontinence are needed.

Factors associated with surgical repair success of female genital fistula in the Democratic Republic of Congo: Experiences of the Fistula Care Plus Project, 2017-2019.

OBJECTIVE: We sought to document outcomes and factors associated with surgical success in hospitals supported by the Fistula Care Plus Project in the Democratic Republic of Congo (DRC), 2017-2019. METHODS: This was a retrospective cohort study analysing routine repair data on women with Female Genital Fistula. Univariate and multivariate analyses were conducted to determine factors associated with successful fistula repair. RESULTS: A total of 895 women were included in this study, with a mean age of 34 years (±13 years). The majority were married or in union (57.4%) and living in rural areas (82.0%), while nearly half were farmers (45.9%). The average duration living with fistula was 8 years (±7). Vesicovaginal (70.5%) and complex (59.8%) fistulas were the most common fistula types. Caesarean section (34.7%), obstructed labour (27.0%) and prolonged labour (23.0%) were the main aetiologies, with the causal deliveries resulting in stillbirth in 88% of cases. The vaginal route (74.9%) was the primary route for surgical repair. The median duration of bladder catheterization after surgery was 14 days (interquartile range [IQR] 7-21). Multivariate analysis revealed that Waaldijk type I fistula (adjusted odds ratio [aOR]:2.71, 95% confidence interval [CI]:1.36-5.40), no previous surgery (aOR:2.63, 95% CI:1.43-3.19), repair at Panzi Hospital (aOR: 2.71, 95% CI:1.36-5.40), and bladder catheterization for less than 10 days (aOR:13.94, 95% CI: 4.91-39.55) or 11-14 days (aOR: 6.07, 95% CI: 2.21-15.31) were associated with better repair outcomes. CONCLUSION: The Fistula Care Plus Project in the DRC recorded good fistula repair outcomes. However, further efforts are needed to promote adequate management of fistula cases.

Frequency and management of non-obstetric fistula in the Democratic Republic of Congo: experience from the Fistula Care Plus project.

OBJECTIVE: To describe the frequency, causes and post-repair outcomes of NOF in hospitals supported by the Fistula Care Plus (FC+) project in the Democratic Republic of Congo. METHODS: Retrospective cohort study from 1 January 2015 to 31 December 2017 in three FC + supported fistula repair sites. RESULTS: Of 1984 women treated for female genital fistula between 2015 and 2017 in the three FC + supported hospitals, 384 (19%) were considered to be non-obstetric fistula (NOF) cases. 49.3% were married/in a relationship at the time of treatment vs. 69% before the fistula, P < 0.001. Type III (n = 247; 64.3%) and type I (n = 121; 31.5%) fistulas according to Kees/Waaldijk classification were the most common. The main causes of NOF were medical procedure (n = 305; 79.4%); of these, caesarean section (n = 234; 76.7%) and hysterectomy (n = 54; 17.7%) were the most common. At hospital discharge, the fistula was closed and dry in 353 women (95.7%). CONCLUSION: Non-obstetric fistula, particularly due to iatrogenic causes, was relatively common in the DRC, calling for more prevention that includes improved quality of care in maternal health services.

OBJECTIF: Décrire la fréquence, les causes et les résultats post-réparation de la fistule non obstétricale (FNO) dans les hôpitaux soutenus par le projet Fistula Care Plus (FC+) en République Démocratique du Congo. MÉTHODES: Etude de cohorte rétrospective du 1er janvier 2015 au 31 décembre 2017 dans trois sites de réparation de fistules soutenus par FC+. RÉSULTATS: Sur 1984 femmes traitées pour une fistule génitale féminine entre 2015 et 2017 dans les trois hôpitaux soutenus par FC+, 384 (19%) étaient considérées comme des cas de FNO. 49,3% étaient mariées/en couple au moment du traitement contre 69% avant la fistule, p <0,001. Les fistules de type III (n = 247; 64,3%) et de type I (n = 121; 31,5%) selon la classification de Kees/Waaldijk étaient les plus courantes. Les principales causes de FNO étaient la procédure médicale (n = 305; 79,4%); parmi lesquelles les césariennes (n = 234; 76,7%) et l'hystérectomie (n = 54; 17,7%) étaient les plus courantes. A la sortie de l'hôpital, la fistule était fermée et sèche chez 353 femmes (95,7%). CONCLUSION: La FNO, en particulier due à des causes iatrogènes, était relativement courante en RDC, appelant à plus de prévention qui comprend l'amélioration de la qualité des soins dans les services de santé maternelle.

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.

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.