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


Background
Female genital stula is a traumatic debilitating injury affecting somewhere between 500,000 to 2 million women, mostly in sub-Saharan Africa, with up to 100,000 annual incident cases. 1,2 Most often caused by prolonged obstructed labor, other etiologies are iatrogenic or traumatic. Many births resulting in stula end in stillbirth. 3 Women with stula experience uncontrollable urinary and/or fecal leakage through the vagina. 4,5 Other consequences of obstructed labor injury complex include neurologic injury, gynecologic morbidity, and orthopedic trauma, resulting in pain, weakness, di culty walking and secondary infertility. 6,7 Women with stula are stigmatized, which restricts their participation in social and economic activities, 3,6 and report substantial psychiatric morbidity. [8][9][10] Although improved global surgical access has begun to reduce the signi cant physical, psychosocial, and economic consequences of stula, women with successful surgery may continue to face adverse experiences or events following surgery. Research estimates the incidence of surgical repair breakdown or post-repair stula recurrence in 2.1%-18.4% of women following surgery, largely within the rst 12 months. [11][12][13][14][15] Post-repair incontinence continues among about one-third of women despite closed stula, 16-18 with some individuals developing incident incontinence despite initial post-surgical resolution. 14,15 Fistula recurrence, urinary and fecal incontinence are associated with signi cant ongoing physical and psychological disability. From the patient perspective, stula closure and persistent incontinence are both associated with ongoing urinary leakage and can have similar repercussions including ongoing psychiatric morbidity and physical discomfort, 6,8-10,19−22 enacted and anticipated stigma causing social isolation, depressive symptoms and continued social and economic consequences. [23][24][25][26][27] Page 5/28 The evidence base regarding persistent post-repair risks and consequences is underdeveloped, which limits clinical and counseling interventions capable of mitigating harmful processes. Most evaluation has been retrospective. Most previous prospective research on repair failure is limited to the stula repair hospitalization or early clinical-follow up, with sparse data on predictors of later stula repair breakdown and recurrence. A study in Guinea reported that women not sexually active at follow-up and those with urethral involvement, damaged bladder neck, and presence of vaginal scarring had signi cantly higher incidence of stula recurrence. 14 Self-reported precursors to stula recurrence in this study included farm work (19%), walking (12%), sexual intercourse (10%), and pregnancy or childbirth (10%). 14 In Ethiopia, recurrence was linked to physical strain, sexual intercourse, heavy work, or jostling during transit. 15 Three smaller studies in Ethiopia, Malawi, and Sudan identi ed stula recurrences occurring during a subsequent childbirth. 12,28,29 Fistula recurrence can be mechanistically characterized as surgical breakdown or re-injury, thus capture of the biological and social factors important to each potential pathway is key. The literature on enhanced recovery after surgery has identi ed patient counseling, physical conditioning, avoidance of alcohol and smoking, and good nutrition as protective. 30 Surgical site infection, an intermediate factor associated with late breakdown, is more common among patients with co-morbidities (particularly diabetes), advanced age, risk indices, and lengthier surgery. 31 Factors responsible for re-injury may include the biological and social structures that increased women's risk of developing a rst stula, including limited access to emergency obstetric care, and it is possible that a woman's risk of stula recurrence following surgery will be different due to the biological alterations occurring within the surgery itself, largely impacted by stula characteristics which are likely to be important predictors of recurrence outcomes. A small Ethiopian study comparing women with and without persistent post-repair urinary incontinence found that leakage was signi cantly more likely among younger women at rst vaginal birth. 22 Urinary incontinence following stula repair is complex due to a variety of anatomic and functional factors at play which often remain uncharacterized, particularly over time. [32][33][34] Research on potential intervention points for reducing persistent and incident post-repair incontinence is limited by the breadth of factors assessed, lack of differentiation between incontinence types, and lack of longitudinal followup. Predictors of immediate post-repair incontinence include stula severity, including size and location, presence of vaginal scarring, and shorter urethral length. 11,16,35 Less is known about incident incontinence following successful surgical resolution. 14,17 To inform clinical and counseling interventions to optimize women's health and quality of life following stula repair, we have developed a mixed-methods research study incorporating a longitudinal cohort to robustly identify predictors of stula repair breakdown and recurrence (Aim 1), identify predictors and characteristics of post-repair incontinence (Aim 2), supplemented by qualitative work among key stakeholders to identify feasible and acceptable strategies for modifying key risk factors of adverse outcomes (Aim 3). The three proposed speci c aims address critical research gaps in the stula literature and are expected to tangibly inform the development of clinical and counseling interventions to mitigate complications, improve post-surgical outcomes and quality of life. Our investigative approach seeks to elucidate which factors (e.g., patient and stula characteristics, surgical factors, and post-repair behaviors and exposures) are most important in determining risk of post-surgical adverse outcome, thereby leading to appropriately targeted and contextually-adapted interventions, and will identify priority research areas needed for women with continued poor outcomes.

Methods
This sequential explanatory mixed-methods study incorporates a longitudinal cohort which will enroll and follow up to 1000 Ugandan women with successfully closed genital stula from the time of stula surgery through 36-months post-surgery (quantitative) and in-depth interviews which will be conducted with ~ 80 purposively selected key stakeholders for translation of quantitative ndings into feasible and acceptable interventions (Fig. 1). The summarized conceptual framework guiding our study ( Fig. 2) highlights factors to be explored including both invariable and potentially mutable factors to develop the evidence base that will allow them to maintain their reproductive and overall health over time.

Study setting and sites
Our research is situated in Uganda which reports a lifetime stula symptom prevalence of 19.2 per 1,000 reproductive aged women and ~ 5,000 new cases annually. 36-38 Uganda's National Fistula Technical Working Group (est. 2002) with representatives from the Ministry of Health, international and national non-governmental organizations (NGOs), medical professionals, and media has focused on increasing stula surgery availability; from 2010 to 2015 the annual number of stula surgeries in Uganda increased from 1377 to 2065. 39 Fistula surgery is available at 20 centers of excellence in Uganda, with 25 trained surgeons with various levels of experience employed by national and regional referral hospitals. Regional literature suggests that genital stula repair is successful among ~ 80% of affected women. 18,40 The research team is partnering with approximately 12 facilities across Uganda providing stula repair, selected for stula repair volume, geographic proximity, prior collaboration and research capability (Fig. 3). Various stula repair models are used across these sites; some sites conduct routine surgeries within ongoing urogynecological services only, others conduct stula repair camps only, and others combine both routine care and camp models. Patients who are under the care of our study providers and research assistants at alternative inconsistent locations will be considered eligible for study participation if they meet study eligibility criteria.

Longitudinal cohort study
Our study will recruit a longitudinal cohort of 1,000 women with successful (closed) vesicovaginal stula repair just after surgery (~ 48 hours later). Participants will be followed for 3 years in total, with data collected via questionnaire at baseline (surgery), 2 weeks (hospital discharge), 6 weeks, 3 months and quarterly thereafter.
Study participants. Inclusion criteria are vesicovaginal stula, completed stula surgery with con rmed closure, age 15 or above (where individuals 15-17 meet Ugandan legal criteria for emancipation), and capable and willing to provide informed consent. Exclusion criteria are do not live within a feasible location for follow-up, operationalized by return travel back to stula repair facility and cellular telephone network.
In the case of fresh stula, we allow for a special circumstance for study participant inclusion criteria: If limited in size (< 2cm) and time since occurrence (< 3 months), catheterization alone may successfully heal ~ 10% of stula. 41 Where a potential participant's stula is considered eligible for treatment via catheterization instead of surgery, and the participant undergoes catheterization and is cured (de ned as stula closure, con rmed by methylene blue test), this woman will be considered eligible for study enrollment if she meets all other study eligibility criteria except having undergone surgery.
Study procedures. Local study researchers will recruit participants into the cohort following con rmation of successful stula repair. Potentially eligible women will be identi ed through review of urogynecology department surgical logbooks, patient medical records, and via direct communication with stula surgeons and other providers. After stula repair, women stay at the repair facility for 14 days at a minimum for post-repair catheterization. The local study researcher will approach women at the facility who meet the eligibility criteria in-person 24-48 hrs after surgery to explain the study to them, assess whether they are eligible and, if so, invite them to participate. The study researcher will complete the full informed consent procedure for those women who indicate that they would like to participate, at a convenient time, with the use of a decision tool developed by the University of California San Francisco Human Subjects Research Ethics Board. The study researcher will then collect participant contact information and administer the baseline questionnaire. Participants will be followed through 36 months post-repair, regardless of outcome.
Two-week data collection will occur prior to hospital discharge. Other planned follow-up data collection (6 weeks and quarterly, starting at 3 months) will occur over mobile phone, given high mobile phone penetration across Uganda. 42,43 Where women do not have their own phone, the study will provide them with a study phone and phone number. Airtime will be provided throughout the study to ensure that study participants have call time (minutes) available and could pay to charge their phone battery as needed.
Clinical exams will be conducted at baseline and 2 weeks post-surgery for stula and repair characterization, and as necessary based on women's self-report of symptom development across the study follow-up to validate outcomes. Participant questionnaires will include a series of signs and symptoms which, if reported, will trigger clinical evaluation at the repair facility for determination of study outcomes: de novo urinary or fecal incontinence signifying stula repair breakdown and recurrence, or any change in urinary incontinence. Women reporting such symptoms on interviewer-administered questionnaire or through other study or clinical communication will return to the stula repair facility for outcome assessment and clinical care following standard clinical procedures. Clinical assessment is routinely conducted at the in-person follow-up appointments at 6 weeks and 3 months post-repair. Transportation costs will be reimbursed for all follow-up data collection required.
It is possible that some participants may require multiple stula surgeries during the course of their study participation. If this occurs, participant follow-up will be adjusted to incorporate data collection at 6 weeks and 3 months following the subsequent surgery, after which the regular quarterly data collection will continue through the originally targeted 36 months after the participant's initial enrollment.
Measures. Primary predictors to be investigated include patient-related factors, stula-related factors, stula repair-related factors, and post-repair behaviors and exposures (Table 1), collected via structured questionnaire at all follow-up data collection points and from medical records and clinical forms when examinations are performed. Participant sociodemographic, stula and stula-repair characteristics will be measured at baseline, with questions on post-repair behaviors and exposures at each follow-up. Outcomes will be screened for at each data collection point; study interviewers will ask a series of questions on signs and symptoms to identify outcomes of interest, women who report new or changed urinary incontinence will be asked to return to the stula repair facility for clinical exam to con rm stula breakdown, recurrence, or incontinence. Women with persistent incontinence without stula breakdown/recurrence will be asked to respond to a short supplemental questionnaire to characterize this incontinence. Women identi ed as pregnant will be asked to respond to a short supplemental questionnaire on pregnancy-related exposures and outcomes. We seek to develop a comprehensive longitudinal dataset capable of supporting broad inquiry into health and wellbeing following stula repair. Data analysis. To identify predictors of post-repair stula breakdown and recurrence (Aim 1), we will rst calculate the incidence of post-repair stula breakdown and recurrence and its 95% con dence interval (CIs) overall by dividing the number of events identi ed by the total person-time observed. The probability of event-free survival at de ned time points will be calculated using the Kaplan-Meier estimate. We will then estimate the individual and joint-effects of the patient, stula, stula repair, and post-repair characteristics on time to post-repair stula breakdown and recurrence in order to identify signi cant factors in time to post-repair stula breakdown and recurrence. We will t proportional hazards frailty survival models to jointly analyze times to post-repair stula breakdown and recurrence. 44 These models will include a shared frailty at the subject level to accommodate within-subject correlation of times to breakdown and recurrence events and interactions of predictors with event type to accommodate potential differences in the association of predictors with times to the events. These models will also include a shared frailty at the provider level since patients will be clustered within providers within facilities. We will t the frailty survival models using routines in Stata statistical analysis software. 45 Prior to tting multivariable models, we will calculate the estimated correlation of all potential predictors to identify any highly correlated groups of predictors. We will not include such groups of predictors in any multivariable models. We will assess the adequacy of the proportional hazards assumption through inspection of Schoen eld residuals as a function of time. In the event our data violate the proportional hazards assumption, we will modify our modelling approach to accommodate interactions or strati cation, as is most appropriate for the data. We will subsequently t one multivariable proportional hazards regression model to document the comparative relationship between patient, stula, stula repair, and post-repair characteristics and the hazard rate of post-repair stula breakdown and recurrence integrating all independent variables that were associated with the outcome in bivariable analyses at a conservative p threshold of p < 0.1. Final model selection will be determined via Akaike's Information Criteria. 52 Secondary analyses will assess time to post-repair stula breakdown (< 3 months post-repair) and time to stula recurrence (≥ 3 months post-repair) separately, and by stula etiology (obstetric versus iatrogenic), although our study is not powered for secondary outcomes.
Other methods will also be used to better understand the contribution of risk factors of stula repair breakdown and recurrence. To overcome the biases inherent to observational research in understanding causal effects, 46 we propose conducting a series of secondary analyses employing propensity score methods. 47 Propensity score methods account for systematic differences in baseline characteristics between exposed and unexposed participants, allowing for effects to be interpreted as causal, similar to a randomized experiment. 48,49 Indeed, propensity score methods may reduce systematic differences between treatment groups compared to covariate adjustment methods. 47 For these analyses, we will estimate a series of models for each key modi able factor to be assessed, rst developing models predicting the probability of the particular exposure using key baseline and other measures deemed to be relevant for developing the treatment weight, followed by analyses of the exposure and outcome incorporating the treatment weight to the methods described above. Finally, we will seek to construct a classi cation rule based on predictors using techniques such as recursive partitioning and random forests using routines in R to identify groups of women de ned by the exposure characteristics that have high probability of experiencing the adverse outcome. 50 To identify predictors and characteristics of post-repair incontinence (Aim 2), we will rst estimate the proportion of women who experience post-repair incontinence and the 95% con dence interval at multiple time points (e.g., 6m, 12m, 2y and 3y). Our primary analysis of predictors of persistent post-repair incontinence will focus on incontinence at 3 months, the time point by which incontinence resolvable through surgery will have resolved per expert opinion. We will rst estimate bivariable relationships between each predictor and post-repair incontinence at this time point using multi-level mixed effects logistic regression modeling procedures in Stata to accommodate the clustered nature of our data. 51 Subsequently, we will estimate one multivariable model to understand the independent and joint effects of patient, stula, stula repair, and post-repair characteristics on post-repair incontinence at 3m, integrating all independent variables that were associated with the outcome in bivariable analyses at conservative p < 0.1 and addressing correlation as described for Aim 1. To identify predictors of incident post-repair incontinence, we will assess incident post-repair incontinence and factors associated with time to incident post-repair incontinence using the survival analysis methods described for Aim 1. Finally, we will conduct analyses of binary predictors of interest employing propensity scores and seek to develop classi cation rules following the methods described for Aim 1.
Sample size. The sample size for our longitudinal cohort study (up to n = 1000 women) was calculated to provide adequate power to detect a minimum difference in effect for patient-related, stula-related, stula-repair related, post-repair behaviors and exposures on risk of stula repair breakdown or recurrence and incontinence of 20% (Aims 1 and 2) using the log-rank test for two-sample comparison of survivor functions (Aim 1) and the Pearson's chi-squared two-sample proportions test (Aim 2). These effect differences were determined to be clinically signi cant based on expert opinion.
Power calculations were developed using Stata's power procedure, with values α = 0.05 and 1-β = 0.80. 51 Prior research on stula recurrence risk elsewhere suggests that factors of interest for our survival analyses (Aim 1) may have hazard ratios ranging from 1.0 to 3.4. 14 Fig. 4 below illustrates the minimum sample size required for estimation of effect estimates ranging from 1.1 to 2.0 with parameters α = 0.05 and 1-β = 0.80, illustrating adequate power for two-sample comparison of survivor functions (i.e., time to stula repair breakdown, time to stula recurrence) with a sample size of 1000 for effect estimates (hazard ratios) of 1.2 or higher, illustrating a 20% or higher risk difference, accommodating some loss to follow-up. Research in other locations has reported a repair breakdown or recurrence rate of approximately 15%. With our target sample size of 1000, we anticipate being able to estimate this incidence with a range of precision of approximately 2.5% (i.e., between 12.8%-17.4%).
Sample size calculations for comparisons between risk factors of post-repair urinary incontinence at 6 and 12 months informing this analysis were estimated using the Pearson's chi-squared two-sample proportions test with parameters α = 0.05 and 1-β = 0.80. The prior literature does not provide a good estimate of what range of potential risk elevation we are likely to see, so we have estimated risk differences of approximately 10 percentage points, across a range of possibilities. As shown in Fig. 4, for a potential comparison of 9 percentage points (e.g., from 1-10%) we achieve power of 0.80 at approximately 200 study participants. On the other end of the range (e.g., a comparison between 50% and 60%; Fig. 6), statistical power of 0.80 is achieved with a minimum sample size of 800 participants.

Qualitative Component
Qualitative research with key stakeholders will be conducted to inform the development of feasible and acceptable intervention concepts targeting risk factors identi ed from our longitudinal cohort aims (Aims 1-2).
Study participants. We will enroll approximately 80 individuals in total, including women with stula, family members, community members, clinical and social service providers, and government. We will purposively sample ~ 40 longitudinal cohort participants to re ect study variability in region and adverse outcome experience. Other key stakeholders (~ 40) will be identi ed through discussion with study investigators, site leads and research assistants, and other clinical and social service providers for stula in Uganda, to maximize variability in respondent region and clinical and patient support roles. Identi ed individuals will be invited to participate over the phone, email, or in-person and those who are interested and are willing to provide informed consent will be scheduled for an in-depth interview with a trained qualitative interviewer at a convenient time and private location. Informed consent for all respondents will be conducted in person, with written or thumbprint con rmation obtained, as appropriate. To respect the privacy and con dentiality of longitudinal cohort participants, permission will rst be sought from the research participant before recruiting potential family member or peer qualitative participants.
Study procedures. Based on our quantitative ndings (Aims 1 and 2), literature, and expert clinical and contextual experience, the research team will develop a semi-structured and open-ended in-depth interview guide for key stakeholder interviews to obtain a nuanced understanding of their perspectives on feasible and acceptable potential intervention opportunities for addressing key risk and causal factors associated with adverse outcomes. Exploration of intervention possibilities with stakeholders may employ constructs from health behavior theories COM-B ('capability', 'opportunity', 'motivation', and 'behavior') model (Fig. 5) and the theoretical domains framework (TDF) for understanding individual and contextual issues, and the Consolidated Framework for Implementation Research (CFIR) for preimplementation assessment of factors important to successful implementation (i.e., intervention characteristics, inner setting (characteristics of implementing organization), outer setting (features of the external context or environment), and implementation process (strategies or tactics for implementation setup or delivery). 52,53 Interviews will be conducted in a private setting by an experienced qualitative interviewer and are anticipated to take 1-2 hours. Participants may be asked to respond iteratively as new data arises during the qualitative process. Interviews will be audio recorded and translated into English and transcribed.
Data analysis. During the iterative interview and analysis process, we will combine COM-B, 54 CFIR, 52 and TDF analyses to identify a series of behavioral and implementation targets for each risk factor identi ed within our quantitative analysis, and for each of these we will 1) classify using the COM-B, 54 2) detail potentially modi able determinants of behavior (e.g., barriers or facilitators) across CFIR 52 domains, 3), list the theoretical domain and techniques for behavior change using the TDF, and 4) develop and assess potential implementation strategies across multiple actors to achieve the desired change.
Further qualitative data analysis will follow a 2-stage systematic process. 55 The rst stage will involve data coding and classi cation by reviewing the transcripts for potential conceptual categories, using the in-depth interview guide. Two types of codes will be employed: deductive and inductive/emergent. First, deductive codes that represent expected in uences will be applied to the data; these will be taken from the existing literature and the theoretical orientation of the interview guide (i.e., COM-B, TFR and CFIR construct list). Next, inductive codes that emerge organically from the data will represent themes that were not expected by the researchers. Emergent themes will be identi ed based on recurrence rate and on similarities and differences noted across the texts. A codebook will be developed from the themes that will include a detailed description of each code, code inclusion and exclusion criteria, and examples of the code in use. Coded data will be analyzed to describe the different dimensions and commonalities of each theme, their distribution across socio-demographic variables, and the patterns and linkages between themes. Comparisons will be made to detect divergent views among participants and to contrast observations by sample population characteristics and type of key stakeholder.
Sample size. The qualitative sample size was selected on the basis of our prior experience with thematic saturation; however, nal sample size will be determined through iterative assessment of theme saturation as data are collected across different participant types. 56

Discussion
In this study, we seek to estimate the contribution of a broad range of potential risk factors of key adverse outcomes following genital stula repair: stula repair breakdown or recurrence, persistent urinary incontinence, and incident urinary incontinence. Our study overcomes several key limitations to the current evidence base through recruiting a sample size capable of robust assessment, employing a longitudinal design to enable evaluation of time-varying contributors and a longer time frame through extending participant follow-up. We also focus on a broad range of patient, clinical, and behavioral characteristics to best inform the development of relevant clinical care interventions, paying particular attention to those that are modi able without excluding those currently considered unmodi able, which will guide us to identifying subgroups at highest risk for ensuring care engagement and in uence subsequent research priorities.
The results of this study will inform key intervention targets for integration into clinical and counseling interventions to mitigate these risks and ensure women's high quality of life following genital stula repair. We engage key stakeholders (e.g., women with stula, family members, community members, clinical and social service providers, government) in interpretation of our ndings and strategy development activities to improve the translation of our quantitative ndings into feasible and acceptable intervention possibilities.
The next steps of this research program include intervention development, employing the strategies arising from the proposed research, assessment of acceptability and feasibility, and testing for effectiveness. This broader program is likely to result in tangible recommendations and intervention strategies for improving women's health and wellbeing following genital stula repair in the short and long term, allowing them to move on to healthy and productive lives. This work is an important corollary to existing efforts to increase access to genital stula surgery among the estimated 500,000-2 million women currently living with this condition. 1,57 In addition to informing an important evidence gap, establishing a large longitudinal cohort such as this represents an important opportunity to develop an important resource for investigating other important research questions on the period following genital stula repair, including those focused on other physical concerns and psychosocial trajectories and outcomes, and we will encourage and support investigation in these areas through professional development among research team members, collaborating with other researchers, and developing capacity through the involvement of trainees in our project.

Dissemination plan
Sharing of ndings generated by this study is an essential part of our research activities and will be carried out in several different ways. The research team's own academic and community settings offer many opportunities for learning and sharing. As the study progresses, we will arrange brie ng meetings with Ministry of Health o cials and other interested stakeholders, to keep them informed of our study progress. We will hold an in-person study dissemination meeting at the end of the study including important Ugandan key stakeholders and media. We will disseminate the study results through presenting at relevant global maternal health conferences. We will take the opportunity to disseminate our ndings at other important outlets, including invited meetings and webinars within the stula and maternal health communities. We will also share our ndings with the international community through peer-reviewed publications. We will make our results available to the community of scientists interested in genital stula and more broadly in maternal and reproductive health. At the end of the study and after the manuscripts addressing the primary analyses are published, the investigators will allow other interested investigators who were not part of the primary study to collaborate on other questions of mutual interest that t within the overall scope of the proposed implementation research. We will make the de-identi ed Overview of study data collection and timeline Summarized conceptual framework between predictors and adverse stula outcomes Page 26/28 Partnering stula repair study sites across Uganda Sample size calculations for robust estimation of stula breakdown or recurrence and persistent incontinence outcomes Page 28/28 Figure 5 COM-B ('capability', 'opportunity', 'motivation', and 'behavior') model to inform intervention exploration for qualitative aim 54