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Abstract：
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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
背景：女性生殖器瘘是一种创伤性衰弱损伤，经常是由长时间的难产引起的，影响了资源较少的地区的50万至200万妇女。膀胱阴道瘘引起尿失禁，和其他发病率可能发生在瘘管的发展过程中。患有瘘管病的妇女受到污名化，限制社会和经济参与，并经历精神病发病率。改进的手术进入减少了瘘管后果,但影响生活质量和健康的修复后风险包括瘘管修复破裂或复发以及持续或改变的尿渗漏或失禁。关于导致不良结局的风险因素的证据有限，阻碍了减轻不良事件的干预措施。本研究旨在量化这些不良风险，并告知临床和咨询干预措施，以优化瘘管修复后妇女的健康和生活质量：确定修复后瘘管破裂和复发（目标1）和修复后尿失禁（目标2）的预测因素和特征，并确定可行和可接受的干预策略(目标3)。
方法：这项混合方法研究纳入了乌干达约12个瘘管修补中心成功完成膀胱阴道瘘修补的妇女的前瞻性队列（目标1-2），然后对关键利益相关者进行定性调查（目标3）。队列参与者将在手术时进行基线访问，然后在2周收集数据，6周,3个月，此后每季度3年。要评估的主要预测因素包括患者相关因素，瘘管相关因素，瘘管修复相关因素,以及修复后的行为和暴露，在所有数据收集点通过结构化问卷收集。临床检查将在基线进行，术后2周,以及症状发展时的结果确认。主要结果是瘘管修复失败或瘘管复发和修复后尿失禁。将与队列参与者（n〜40）和其他关键利益相关者（约40包括家庭，同行,社区成员和临床/社会服务提供者)告知建议的可行性和可接受性。
结论：参与者招募正在进行中。这项研究预计将确定可以直接改善瘘管修复和修复后计划以及妇女预后的关键预测因子。优化健康和生活质量。此外，我们的研究将创建一个全面的纵向数据集,能够支持对瘘管修复后健康状况的广泛调查.试验注册ClinicalTrials.gov标识符：NCT05437939。
女性生殖器瘘是一种外伤性产伤，发生在无法获得紧急分娩护理的地方。它会导致无法控制的尿液泄漏，并与其他身体和心理症状有关。由于尿液泄漏及其气味，患有瘘管病的妇女受到污名化，这具有心理健康和经济后果。确保妇女获得瘘管手术和持续健康对于限制瘘管的影响很重要。瘘管手术后,健康风险，如瘘管修复失败或复发或尿漏的变化可能发生，但这段时间的研究是有限的。我们的研究旨在定量测量这些健康风险和影响这些风险的因素，和病人一起工作，社区成员,和瘘管护理提供者提出解决方案。我们将在瘘管手术时招募多达1000名参与者进入我们的研究，并随访他们三年。我们将收集患者社会人口统计学特征的数据，临床病史,通过患者调查和病历审查，以及瘘管修复后的行为。如果参与者尿漏有变化，他们将被要求返回瘘管修复医院进行检查。我们将采访大约80个人，以获得他们对可行和可接受的干预选择的想法。我们希望这项研究将有助于了解瘘管修复后健康状况不佳的危险因素，最终,改善瘘管术后妇女的健康和生活质量。
方法：这项混合方法研究纳入了乌干达约12个瘘管修补中心成功完成膀胱阴道瘘修补的妇女的前瞻性队列（目标1-2），然后对关键利益相关者进行定性调查（目标3）。队列参与者将在手术时进行基线访问，然后在2周收集数据，6周,3个月，此后每季度3年。要评估的主要预测因素包括患者相关因素，瘘管相关因素，瘘管修复相关因素,以及修复后的行为和暴露，在所有数据收集点通过结构化问卷收集。临床检查将在基线进行，术后2周,以及症状发展时的结果确认。主要结果是瘘管修复失败或瘘管复发和修复后尿失禁。将与队列参与者（n〜40）和其他关键利益相关者（约40包括家庭，同行,社区成员和临床/社会服务提供者)告知建议的可行性和可接受性。
结论：参与者招募正在进行中。这项研究预计将确定可以直接改善瘘管修复和修复后计划以及妇女预后的关键预测因子。优化健康和生活质量。此外，我们的研究将创建一个全面的纵向数据集,能够支持对瘘管修复后健康状况的广泛调查.试验注册ClinicalTrials.gov标识符：NCT05437939。
女性生殖器瘘是一种外伤性产伤，发生在无法获得紧急分娩护理的地方。它会导致无法控制的尿液泄漏，并与其他身体和心理症状有关。由于尿液泄漏及其气味，患有瘘管病的妇女受到污名化，这具有心理健康和经济后果。确保妇女获得瘘管手术和持续健康对于限制瘘管的影响很重要。瘘管手术后,健康风险，如瘘管修复失败或复发或尿漏的变化可能发生，但这段时间的研究是有限的。我们的研究旨在定量测量这些健康风险和影响这些风险的因素，和病人一起工作，社区成员,和瘘管护理提供者提出解决方案。我们将在瘘管手术时招募多达1000名参与者进入我们的研究，并随访他们三年。我们将收集患者社会人口统计学特征的数据，临床病史,通过患者调查和病历审查，以及瘘管修复后的行为。如果参与者尿漏有变化，他们将被要求返回瘘管修复医院进行检查。我们将采访大约80个人，以获得他们对可行和可接受的干预选择的想法。我们希望这项研究将有助于了解瘘管修复后健康状况不佳的危险因素，最终,改善瘘管术后妇女的健康和生活质量。
