Identifying opportunities for prevention of adverse outcomes following female genital fistula repair: protocol for a mixed-methods study in Uganda.

BACKGROUND: Female genital fistula is a traumatic debilitating injury, frequently caused by prolonged obstructed labor, affecting between 500,000-2 million women in lower-resource settings. Vesicovaginal fistula causes urinary incontinence, and other morbidity may occur during fistula development. Women with fistula are stigmatized, limit social and economic engagement, and experience psychiatric morbidity. Improved surgical access has reduced fistula consequences yet post-repair risks impacting quality of life and well-being include fistula repair breakdown or recurrence and ongoing or changing urine leakage or incontinence. Limited evidence on risk factors contributing to adverse outcomes hinders interventions to mitigate adverse events. This study aims to quantify these adverse risks and inform clinical and counseling interventions to optimize women's health and quality of life following fistula repair through: identifying predictors and characteristics of post-repair fistula breakdown and recurrence (Objective 1) and post-repair incontinence (Objective 2), and to identify feasible and acceptable intervention strategies (Objective 3). METHODS: This mixed-methods study incorporates a prospective cohort of women with successful vesicovaginal fistula repair at approximately 12 fistula repair centers in Uganda (Objectives 1-2) followed by qualitative inquiry among key stakeholders (Objective 3). Cohort participants will have a baseline visit at the time of surgery followed by data collection at 2 weeks, 6 weeks, 3 months and quarterly thereafter for 3 years. Primary predictors to be evaluated include patient-related factors, fistula-related factors, fistula repair-related factors, and post-repair behaviors and exposures, collected via structured questionnaire at all data collection points. Clinical exams will be conducted at baseline, 2 weeks post-surgery, and for outcome confirmation at symptom development. Primary outcomes are fistula repair breakdown or fistula recurrence and post-repair incontinence. In-depth interviews will be conducted with cohort participants (n ~ 40) and other key stakeholders (~ 40 including family, peers, community members and clinical/social service providers) to inform feasibility and acceptability of recommendations. DISCUSSION: Participant recruitment is underway. This study is expected to identify key predictors that can directly improve fistula repair and post-repair programs and women's outcomes, optimizing health and quality of life. Furthermore, our study will create a comprehensive longitudinal dataset capable of supporting broad inquiry into post-fistula repair health. Trial Registration ClinicalTrials.gov Identifier: NCT05437939.

Female genital fistula is a traumatic birth injury which occurs where access to emergency childbirth care is poor. It causes uncontrollable urine leakage and is associated with other physical and psychological symptoms. Due to the urine leakage and its odor, women with fistula are stigmatized which has mental health and economic consequences. Ensuring women's access to fistula surgery and ongoing wellbeing is important for limiting the impact of fistula. After fistula surgery, health risks such as fistula repair breakdown or recurrence or changes to urine leakage can happen, but studies during this time are limited. Our study seeks to measure these health risks and factors influencing these risks quantitatively, and work with patients, community members, and fistula care providers to come up with solutions. We will recruit up to 1000 participants into our study at the time of fistula surgery and follow them for three years. We will collect data on patient sociodemographic characteristics, clinical history, and behavior after fistula repair through patient survey and medical record review. If participants have changes in urine leakage, they will be asked to return to the fistula repair hospital for exam. We will interview about 80 individuals to obtain their ideas for feasible and acceptable intervention options. We expect that this study will help to understand risk factors for poor health following fistula repair and, eventually, improve women's health and quality of life after fistula.

The social, economic, emotional, and physical experiences of caregivers for women with female genital fistula in Uganda: A qualitative study.

ABSTRACTThis study aimed to explore the firsthand experiences of informal primary caregivers of women with female genital fistula in Uganda. Caregivers that accompanied women for surgery at Mulago National Teaching and Referral Hospital were recruited between January and September 2015. Caregivers participated in in-depth interviews and focus groups. Data were analysed thematically and informed adaptation of a conceptual framework. Of 43 caregivers, 84% were female, 95% family members, and most married and formally employed. Caregivers engaged in myriad personal care and household responsibilities, and described being on call for an average of 22.5 h per day. Four overlapping themes emerged highlighting social, economic, emotional, and physical experiences/consequences. The caregiving experience was informed by specific caregiver circumstances (e.g. personal characteristics, care needs of their patient) and dynamic stressors/supports within the caregiver's social context. These results demonstrate that caregivers' lived social, economic, emotional, and physical experiences and consequences are influenced by both social factors and individual characteristics of both the caregiver and their patient. This study may inform programmes and policies that increase caregiving supports while mitigating caregiving stressors to enhance the caregiving experience, and ultimately ensure its feasibility, particularly in settings with constrained resources.

Factors associated with reintegration trajectory following female genital fistula surgery in Uganda.

BACKGROUND: A female genital fistula, primarily caused by prolonged obstructed labor or after cesarean delivery in resource-limited countries, affects 500,000 to 2,000,000 women worldwide. Fistula is preventable with timely access to high-quality obstetrical care. Access to surgical repair of a female genital fistula has greatly increased over time. However, research surrounding postrepair reintegration, the process of returning to an individual's normal life, remains limited, and further efforts are needed to understand the factors shaping women's ability to rebuild their relationships and lives following repair. OBJECTIVE: This study aimed to characterize the 12-month reintegration trajectory after female genital fistula repair by participant sociodemographic and clinical characteristics. STUDY DESIGN: This study analyzed quantitative survey and medical record data of women (N=60) participating in a longitudinal cohort study assessing recovery after genital fistula repair in Uganda, with baseline and 4 quarterly follow-up assessments in 12 months. The primary outcome of reintegration was assessed using a 19-item postfistula repair reintegration instrument (range, 0-100) where a higher score represents better reintegration. Predictors of interest included parity and living children, quality of life, depressive symptoms at baseline, self-esteem, stigma, trauma, physical symptoms, and social support. We described participant baseline characteristics using means and proportions and estimated a series of mixed-effects linear regression models, including interactions of characteristics with time to understand how these characteristics influence reintegration trajectory in the 12 months after repair. RESULTS: The participants' physical and psychosocial morbidities at baseline were high; more than 80% of participants reported fistula-related physical symptoms, 82% of participants described their general health as poor, and measures of self-esteem, overall social support, and overall quality of life were low. The mean reintegration score at baseline was 33 (standard deviation, 20), which increased to 78 (standard deviation, 19) at 12 months after fistula repair. The participant sociodemographic characteristics statistically associated with reintegration included any living children (ß, 1.08; 95% confidence interval, -0.08 to 2.23). Moreover, psychosocial factors significantly affected reintegration with steeper trajectories for women with depressive symptoms (ß, 0.89; 95% confidence interval, 0.02-1.75) or women experiencing internalized stigma (ß, 0.05; 95% confidence interval, -0.00 to 0.11) and less steep for those with higher self-esteem (ß, -0.11; 95% confidence interval, -0.24 to 0.01), overall social support (ß, -0.06; 95% confidence interval, -0.12 to -0.01), and partner support (ß, -0.21; 95% confidence interval, -0.35 to -0.07). CONCLUSION: Understanding the prominent factors associated with differences in reintegration trajectories across the year after genital fistula surgery has the potential to inform interventions that mitigate challenges and improve women's postrepair recovery experiences.

Characteristics and outcomes of patients with pelvic organ prolapse: an analysis of data from Mulago National Referral Hospital from 2007-2016.

Introduction: Pelvic organ prolapse (POP) is associated with negative physical, social, psychological, and sexual experiences. There is paucity of data in low and middle income countries like Uganda. The purpose of this study was to describe clinical characteristics and outcomes of patients undergoing surgery for POP from 2007 to 2016. Methods: The study was conducted at Mulago National Referral Hospital from 2014 to 2016. We conducted a retrospective review of the urogynecology surgical records using a standardized medical record abstraction form. Data of 222 POP patients were abstracted and managed using REDCap. Analysis was performed using Stata statistical software, v14. Results: The mean participant age and parity was 57 years and 7 respectively. Ninety four percent of participants presented with a mass protruding from the vagina, 38% with uterine prolapse and 32% with cystocoele. Anaemia and hypertension were common comorbidities. Women underwent a variety of surgery types, and 35% experienced persistent pain post-operatively. At hospital discharge, 83% had achieved either complete resolution or improvement in their condition. Conclusions: Measures encouraging presentation for care as soon as symptoms are experienced and reduction of total fertility rate will be beneficial. Patients with POP should be routinely screened for anaemia and hypertension.

Contraceptive preferences and adoption following female genital fistula surgery in Uganda: a mixed-methods study.

BACKGROUND: Female genital fistula, largely caused by prolonged obstructed labour, is treated by surgical repair. Preventing pregnancy for a minimum period post-repair is recommended to ensure adequate healing and optimize post-repair outcomes. METHODS: We examined contraceptive preferences and use among Ugandan fistula patients (n = 60) in the year following genital fistula surgery using mixed-methods. Sexual activity, contraceptive use and pregnancy status were recorded quarterly for 12 months after surgery. In-depth interviews among purposively selected participants (n = 30) explored intimate relationships, sexual experiences, reproductive intentions, and contraceptive use. RESULTS: Median participant age was 28 years and almost half (48%) were married or living with partners. Counselling was provided to 97% of participants on delaying sexual intercourse, but only 59% received counselling on contraception. Sexual activity was reported by 32% after 6 months and 50% after 12 months. Eighty-three percent reported not trying for pregnancy. Among sexually active participants, contraceptive use was low at baseline (36%) but increased to 73% at 12 months. Six (10%) women became pregnant including two within 3 months post-repair. Interview participants who desired children immediately were young, had fewer children, experienced stillbirth at fistula development, and felt pressure from partners. Women adopted contraception to fully recover from fistula surgery and avoid adverse outcomes. Others simply preferred to delay childbearing. Reasons cited for not adopting contraception included misconceptions related to their fertility and to contraceptive methods and insufficient or unclear healthcare provider advice on their preferred methods. CONCLUSIONS: A high proportion of patients were not counselled by healthcare providers on contraception. Provision of comprehensive patient-centred contraceptive counselling at the time of fistula surgery and beyond is important for patients to optimize healing from fistula and minimize recurrence, as well as to meet their own reproductive preferences.

Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair: Protocol for a Mixed-Methods Study in Uganda.

Background: Female genital fistula is a traumatic debilitating injury, frequently caused by prolonged obstructed labor, affecting between 500,000-2 million women in lower-resource settings. Vesicovaginal fistula causes urinary incontinence. Other gynecologic, neurologic and orthopedic morbidity may occur during fistula development. Women with fistula are stigmatized; limit engagement in social, economic, or religious activities; and report high psychiatric morbidity. Improved global surgical access has reduced fistula consequences yet post-repair risks impacting quality of life and well-being include fistula repair breakdown or recurrence and ongoing or changing urine leakage or incontinence. Limited evidence on risk factors contributing to adverse outcomes hinders interventions to mitigate adverse events, protecting health and quality of life after surgery. This study seeks to identify predictors and characteristics of post-repair fistula breakdown and recurrence (Aim 1) and post-repair incontinence (Aim 2), and to identify feasible and acceptable intervention strategies (Aim 3). Methods: This mixed-methods study incorporates a prospective cohort study of women with successful vesicovaginal fistula repair at approximately 12 fistula repair centers and affiliated care sites in Uganda (Aims 1-2) followed by qualitative inquiry among key stakeholders (Aim 3). Cohort participants will have a baseline visit at the time of surgery followed by data collection at 2 weeks, 6 weeks, 3 months and quarterly thereafter for 3 years. Primary predictors to be evaluated include patient-related factors, fistula-related factors, fistula repair-related factors, and post-repair behaviors and exposures, collected via structured questionnaire at all data collection points. Clinical exams will be conducted at baseline, 2 weeks post-surgery, and for outcome confirmation at symptom development. Primary outcomes are fistula repair breakdown or fistula recurrence and post-repair incontinence. In-depth interviews will be conducted with cohort participants (n ~ 40) and other key stakeholders (~ 40 including family, peers, community members and clinical/social service providers) to develop feasible and acceptable intervention concepts for adjustment of identified risk factors. Discussion: Participant recruitment is underway. This study is expected to identify key predictors that can directly improve fistula repair and post-repair programs and women's outcomes, optimizing health and quality of life. Furthermore, our study will create a comprehensive longitudinal dataset capable of supporting broad inquiry into post-fistula repair health. Trial Registration: ClinicalTrials.gov Identifier: NCT05437939.

Women's sexual activity and experiences following female genital fistula surgery.

BACKGROUND: Surgical repair has a transformative impact on the lives of women affected by female genital fistula; however, various physical, social, and economic challenges may persist postrepair and prevent complete reengagement in relationships and communities. Nuanced investigation of these experiences is needed to inform programming that aligns with women's reintegration needs. AIM: We investigated the sexual activity resumption, experiences, and concerns of women in Uganda during the year following genital fistula repair surgery. METHODS: Women were recruited from Mulago Hospital between December 2014 and June 2015. We collected data at baseline and 4 times postsurgery about sociodemographic characteristics and physical/psychosocial status; we also assessed sexual interest and satisfaction twice. We performed in-depth interviews with a subset of participants. We analyzed quantitative findings via univariate analyses, and qualitative findings were coded and analyzed thematically. OUTCOMES: We assessed sexual readiness, fears, and challenges following surgical repair of female genital fistula using quantitative and qualitative measures of sexual activity, pain with sex, sexual interest/disinterest, and sexual satisfaction/dissatisfaction. RESULTS: Among the 60 participants, 18% were sexually active at baseline, which decreased to 7% postsurgery and increased to 55% at 1 year after repair. Dyspareunia was reported by 27% at baseline and 10% at 1 year; few described leakage during sex or vaginal dryness. Qualitative findings showed wide variance of sexual experiences. Some reported sexual readiness quickly after surgery, and some were not ready after 1 year. For all, fears included fistula recurrence and unwanted pregnancy. CONCLUSION: These findings suggest that postrepair sexual experiences vary widely and intersect meaningfully with marital and social roles following fistula and repair. In addition to physical repair, ongoing psychosocial support is needed for comprehensive reintegration and the restoration of desired sexuality.

Feasibility and acceptability of mobile phone data collection for longitudinal follow-up among patients treated for obstetric fistula in Uganda.

Rapid dissemination of mobile technology provides substantial opportunity for overcoming challenges reaching rural and marginalized populations. We assessed feasibility and acceptability of longitudinal mobile data capture among women undergoing fistula surgery in Uganda (n = 60) in 2014-2015. Participants were followed for 12 months following surgery, with data captured quarterly, followed by interviews at 12 months. Participant retention was high (97%). Most respondents reported no difficulty with mobile data capture (range 93%-100%), and preferred mobile interview (88%-100%). Mobile data capture saved 1000 person-hours of transit and organizational time. Phone-based mobile data collection provided social support. Our results support this method for longitudinal studies among geographically and socially marginalized populations.

Validation of an adapted instrument to measure female genital fistula-related stigma.

Female genital fistula results in severe physical, psychological, and social sequelae. Qualitative research confirms stigma pervasiveness; however, no quantitative instrument exists to measure fistula-related stigma. We adapted an existing HIV-related stigma instrument to fistula-related stigma and assessed its reliability and validity. We recruited 60 Ugandan women seeking genital fistula surgery (December 2014-June 2015). We used exploratory factor analysis to explore the scale's latent structure and evaluated internal consistency reliability with Raykov's ρ statistic. We assessed construct validity through linear regression of stigma with quality of life, depressive symptoms and self-esteem. We retained 15 items across factors 'enacted stigma' and 'internalised stigma' (ρ = 0.960 and ρ = 0.748, respectively). Stigma was inversely associated with all quality of life domains; effect sizes were largest for environmental (enacted stigma, 0.69-point reduction) and psychological (internalised stigma, 0.67-point reduction) domains. Both stigma domains were associated positively with depressive symptoms and inversely with self-esteem, with 0.75 and 1.05-point increases in depressive symptoms and 0.45 and 0.77-point decreases in self-esteem for enacted and internalised stigma, respectively. Results suggest the reliability and validity of the adapted fistula stigma instrument. This instrument may help us understand stigma levels, compare stigma across individuals and communities, prioritise stigma-reduction strategies, and assess intervention impact.

Rehabilitation and reintegration programming adjunct to female genital fistula surgery: A systematic scoping review.

BACKGROUND: Female genital fistula is associated with significant physical, psychological, and economic consequences; however, a knowledge and practice gap exists around services adjunct to fistula surgery. OBJECTIVES: To examine rehabilitation and reintegration services provided adjunct to genital fistula surgery, map existing programming and outcomes, and identify areas for additional research. SEARCH STRATEGY: We searched the published and grey literature from January 2000 to June 2019. Two reviewers screened articles and extracted data using standardized methods. SELECTION CRITERIA: Research and programmatic articles describing service provision in addition to female genital fistula surgery were included. DATA COLLECTION AND ANALYSIS: Of 3047 published articles and 2623 unpublished documents identified, 26 and 55, respectively, were analyzed. MAIN RESULTS: Programming identified included combinations of health education, physical therapy, social support, psychosocial counseling, and economic empowerment, largely in sub-Saharan Africa. Improvements were noted in physical and psychosocial health. CONCLUSIONS: Existing literature supports holistic fistula care through adjunct reintegration programming. Improving the evidence base requires implementing robust study designs, increasing reporting detail, and standardizing outcomes across studies. Increased financing for holistic fistula care is critical for developing and supporting programming to ensure positive outcomes.

Women's experiences of fistula-related stigma in Uganda: a conceptual framework to inform stigma-reduction interventions.

Fistula-related stigma is common. The absence of a unifying conceptual framework prevents a nuanced understanding of the nature of fistula-related stigma, comparison across contexts and the ability to contrast with other stigmas. It also hinders intervention development. We conducted in-depth interviews or focus groups with 60 women who had undergone fistula surgery 6-24 months prior at Mulago Hospital in Kampala, Uganda in 2014. Transcripts were analysed for experiences and consequences of enacted, anticipated and internalised stigma. Narratives revealed experiences with enacted stigma, including gossip, verbal abuse and social exclusion. Women also anticipated and feared stigma in the future. Internalised stigma reports revealed shame and low self-esteem: self-worth reduction, feeling disgraced and envisioning no future. Consequences included social isolation, changes to normal activities, non-disclosure and poor mental health. Refining stigma theory to specific conditions has resulted in a more nuanced understanding of stigma dimensions, manifestations, mechanisms and consequences, permitting comparison across contexts and populations and the development of stigma-reduction interventions. These lessons should be applied to fistula, acknowledging unique features: concealability, the potential for treatment, lack of community awareness and the social consequences of stillbirth. Reducing fistula-related stigma requires timely surgery and supportive care, stigma-reduction interventions and addressing the complex societal structures that perpetuate fistula.

Rehabilitation and reintegration programming adjunct to female genital fistula surgery: a scoping review protocol.

INTRODUCTION: Female genital fistula is a debilitating traumatic injury, largely birth-associated, globally affecting up to 2 million women, mostly in sub-Saharan Africa. Fistula has significant physical, psychological and economic consequences. Women often face challenges in reintegrating and resuming prior roles despite successful surgery. Synthesising the evidence on services adjunct to fistula surgery and their outcomes is important for developing the evidence base for best practices and identifying research priorities. This scoping review seeks to examine the range of rehabilitation and reintegration services provided as adjunct to genital fistula surgery, map the existing programming and outcomes, and identify areas for additional research. METHODS AND ANALYSIS: Our scoping review is informed by existing methodological frameworks and will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses-ScR guidelines. The search strategy will be applied to nine biomedical, public health and social science databases. The initial search was completed on 27 September 2018. Grey literature will be identified through targeted Google searches and from organisational websites identified as relevant by the United Nations Population Fund (UNFPA) Campaign to End Fistula. We will iteratively build our search strategy through term harvesting and review, and search reference lists of reports and articles to identify additional studies. Two reviewers will independently screen titles and abstracts, followed by full-text screening of all potentially relevant articles and standardised data extraction. Articles eligible for inclusion will discuss research or programmatic efforts around service provision in adjunct to surgery among females with genital fistula. Data will be presented in summary tables accompanied by narrative description. ETHICS AND DISSEMINATION: Ethics approval is not required for a scoping review. Our results can be used to inform policy, serve as support for funding and development of reintegration programmes and highlight areas for subsequent research. Results will be disseminated at relevant conferences and published in a peer-reviewed journal.

Trajectories of women's physical and psychosocial health following obstetric fistula repair in Uganda: a longitudinal study.

OBJECTIVES: To explore trajectories of physical and psychosocial health, and their interrelationship, among women completing fistula repair in Uganda for 1 year post-surgery. METHODS: We recruited a 60-woman longitudinal cohort at surgical hospitalisation from Mulago Hospital in Kampala Uganda (Dec 2014-June 2015) and followed them for 1 year. We collected survey data on physical and psychosocial health at surgery and at 3, 6, 9 and 12 months via mobile phone. Fistula characteristics were abstracted from medical records. All participants provided written informed consent. We present univariate analysis and linear regression results. RESULTS: Across post-surgical follow-up, most women reported improvements in physical and psychosocial health, largely within the first 6 months. By 12 months, urinary incontinence had declined from 98% to 33% and general weakness from 33% to 17%, while excellent to good general health rose from 0% to 60%. Reintegration, self-esteem and quality of life all increased through 6 months and remained stable thereafter. Reported stigma reduced, yet some negative self-perception remained at 12 months (mean 17.8). Psychosocial health was significantly impacted by the report of physical symptoms; at 12 months, physical symptoms were associated with a 21.9 lower mean reintegration score (95% CI -30.1, -12.4). CONCLUSIONS: Our longitudinal cohort experienced dramatic improvements in physical and psychosocial health after surgery. Continuing fistula-related symptoms and the substantial differences in psychosocial health by physical symptoms support additional intervention to support women's recovery or more targeted psychosocial support and reintegration services to ensure that those coping with physical or psychosocial challenges are appropriately supported.

Development and preliminary validation of a post-fistula repair reintegration instrument among Ugandan women.

BACKGROUND: Obstetric fistula is a debilitating and traumatic birth injury affecting 2-3 million women globally, mostly in sub-Saharan Africa and Asia. Affected women suffer physically, psychologically and socioeconomically. International efforts have increased access to surgical treatment, yet attention to a holistic outcome of post-surgical rehabilitation is nascent. We sought to develop and pilot test a measurement instrument to assess post-surgical family and community reintegration. METHODS: We conducted an exploratory sequential mixed-methods study, beginning with 16 in-depth interviews and four focus group discussions with 17 women who underwent fistula surgery within two previous years to inform measure development. The draft instrument was validated in a longitudinal cohort of 60 women recovering from fistula surgery. Qualitative data were analyzed through thematic analysis. Socio-demographic characteristics were described using one-way frequency tables. We used exploratory factor analysis to determine the latent structure of the scale, then tested the fit of a single higher-order latent factor. We evaluated internal consistency and temporal stability reliability through Raykov's ρ and Pearson's correlation coefficient, respectively. We estimated a series of linear regression models to explore associations between the standardized reintegration measure and validated scales representing theoretically related constructs. RESULTS: Themes central to women's experiences following surgery included resuming mobility, increasing social interaction, improved self-esteem, reduction of internalized stigma, resuming work, meeting their own needs and the needs of dependents, meeting other expected and desired roles, and negotiating larger life issues. We expanded the Return to Normal Living Index to reflect these themes. Exploratory factor analysis suggested a four-factor structure, titled 'Mobility and social engagement', 'Meeting family needs', 'Comfort with relationships', and 'General life satisfaction', and goodness of fit statistics supported a higher-order latent variable of 'Reintegration.' Reintegration score correlated significantly with quality of life, depression, self-esteem, stigma, and social support in theoretically expected directions. CONCLUSION: As more women undergo surgical treatment for obstetric fistula, attention to the post-repair period is imperative. This preliminary validation of a reintegration instrument represents a first step toward improving measurement of post-surgical reintegration and has important implications for the evidence base of post-surgical reintegration epidemiology and the development and evaluation of fistula programming.

Vaginal Calculus in a Woman With Mixed Urinary Incontinence and Vaginal Mesh Exposure.

Vaginal calculi are extremely rare and are most commonly encountered in the setting of an urethrovaginal or vesicovaginal fistula. We present a case of a 72-year-old woman with mixed urinary incontinence and vaginal mesh exposure incidentally found to have a large vaginal calculus. We removed the calculus surgically and analyzed the components. Results demonstrated the presence of ammonium-magnesium phosphate hexahydrate and carbonate apatite.

Beyond repair - family and community reintegration after obstetric fistula surgery: study protocol.

BACKGROUND: Obstetric fistula is a debilitating birth injury that affects an estimated 2-3 million women globally, most in sub-Saharan Africa and Asia. The urinary and/or fecal incontinence associated with fistula affects women physically, psychologically and socioeconomically. Surgical management of fistula is available with clinical success rates ranging from 65-95 %. Previous research on fistula repair outcomes has focused primarily on clinical outcomes without considering the broader goal of successful reintegration into family and community. The objectives for this study are to understand the process of family and community reintegration post fistula surgery and develop a measurement tool to assess long-term success of post-surgical family and community reintegration. METHODS: This study is an exploratory sequential mixed-methods design including a preliminary qualitative component comprising in-depth interviews and focus group discussions to explore reintegration to family and community after fistula surgery. These results will be used to develop a reintegration tool, and the tool will be validated within a small longitudinal cohort (n = 60) that will follow women for 12 months after obstetric fistula surgery. Medical record abstraction will be conducted for patients managed within the fistula unit. Ethical approval for the study has been granted. DISCUSSION: This study will provide information regarding the success of family and community reintegration among women returning home after obstetric fistula surgery. The clinical and research community can utilize the standardized measurement tool in future studies of this patient population.

Teaching surgical skills using video internet communication in a resource-limited setting.

OBJECTIVE: To study the feasibility and acceptability of using video Internet communication to teach and evaluate surgical skills in a low-resource setting. METHODS: This case-controlled study used video Internet communication for surgical skills teaching and evaluation. We randomized intern physicians rotating in the Obstetrics and Gynecology Department at Mulago Hospital at Makerere University in Kampala, Uganda, to the control arm (usual practice) or intervention arm (three video teaching sessions with University of California, San Francisco faculty). We made preintervention and postintervention videos of all interns tying knots using a small video camera and uploaded the files to a file hosting service that offers cloud storage. A blinded faculty member graded all of the videos. Both groups completed a survey at the end of the study. RESULTS: We randomized 18 interns with complete data for eight in the intervention group and seven in the control group. We found score improvement of 50% or more in six of eight (75%) interns in the intervention group compared with one of seven (14%) in the control group (P=.04). Scores declined in five of the seven (71%) controls but in none in the intervention group. Both intervention and control groups used attendings, colleagues, and the Internet as sources for learning about knot-tying. The control group was less likely to practice knot-tying than the intervention group. The trainees and the instructors felt this method of training was enjoyable and helpful. CONCLUSION: Remote teaching in low-resource settings, where faculty time is limited and access to visiting faculty is sporadic, is feasible, effective, and well-accepted by both learner and teacher. LEVEL OF EVIDENCE: II.

Phase 2a study assessing colonization efficiency, safety, and acceptability of Lactobacillus crispatus CTV-05 in women with bacterial vaginosis.

BACKGROUND: Bacterial vaginosis (BV) is a common vaginal infection caused by a lack of endogenous lactobacilli and overgrowth of pathogens that frequently recurs following antibiotic treatment. METHODS: A phase 2a study assessed colonization efficiency, safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by a vaginal applicator. Twenty-four women with BV were randomized in a 3:1 ratio of active product to placebo. Participants used LACTIN-V at 2 × 10 colony-forming units (cfu)/dose or placebo for 5 initial consecutive days, followed by a weekly application over 2 weeks. They returned for follow-up on Days 10 and 28. RESULTS: Sixty-one percent of the 18 women randomized to the LACTIN-V group were colonized with L. crispatus CTV-05 at Day 10 or Day 28. Among LACTIN-V users with complete adherence to the study regimen, 78% were colonized at Day 10 or Day 28. Of the 120 adverse events (AEs) that occurred, 108 (90%) and 12 (10%) were of mild and moderate severity, respectively. AEs were evenly distributed between the LACTIN-V and placebo group. Of the total AEs, 93 (78%) were genitourinary in origin. The most common genitourinary AEs included vaginal discharge (46%), abdominal pain (46%), dysuria (21%), pollakiuria (21%), vaginal odor (21%), and genital pruritus (17%). No grade 3 or 4 AEs or serious AEs occurred and no deep epithelial disruption was seen during colposcopic evaluation. The product was well tolerated and accepted. CONCLUSIONS: LACTIN-V colonized well, and was safe and acceptable in women treated for BV.

Objective assessment of vaginal surgical skills.

OBJECTIVE: To develop and validate an instrument to assess surgical skills during vaginal surgery. STUDY DESIGN: Trainees from 2 institutions were directly assessed in the operating room by supervising surgeons while performing a vaginal hysterectomy using the new Vaginal Surgical Skills Index, global rating scale, and visual analogue scale. Trainees were assessed again by the same surgeons 4 weeks after the live surgery and by a blinded outside reviewer using a videotape of the case. Internal consistency, interrater and intrarater reliability, and construct validity were evaluated. RESULTS: Two hundred twelve evaluations were analyzed on 76 surgeries from 27 trainees. There was good internal consistency, interrater, and intrarater reliability. Vaginal Surgical Skills Index scores correlated with global rating score and visual analog scale scores. Increasing Vaginal Surgical Skills Index scores significantly correlated with year of training and surgical volume with an estimated increase in score of 0.3 per hysterectomy performed. CONCLUSION: The Vaginal Surgical Skills Index is a feasible, reliable, and valid instrument to assess vaginal surgical skills.

Establishing cutoff scores on assessments of surgical skills to determine surgical competence.

OBJECTIVE: The aim of this study was to establish minimum cutoff scores on intraoperative assessments of surgical skills to determine surgical competence for vaginal hysterectomy. STUDY DESIGN: Two surgical rating scales, the Global Rating Scale of Operative Performance and the Vaginal Surgical Skills Index, were used to evaluate trainees while performing vaginal hysterectomy. Cutoff scores were determined using the Modified Angoff method. RESULTS: Two hundred twelve evaluations were analyzed on 76 surgeries performed by 27 trainees. Trainees were considered minimally competent to perform vaginal hysterectomy if total absolute scores (95% confidence interval) on Global Rating Scale = 18 (16.5-20.3) and Vaginal Surgical Skills Index = 32 (27.7-35.5). On average, trainees met new cutoffs after performing 21 and 27 vaginal hysterectomies, respectively. With the new cutoffs applied to the same cohort of fourth-year obstetrics and gynecology trainees, all residents achieved competency in performing vaginal hysterectomy by the end of their gynecology rotations. CONCLUSION: Standard-setting methods using cutoff scores may be used to establish competence in vaginal surgery.