Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, 550 16Th Street, San Francisco, CA, 94158, USA.
Department of Urogynecology, Mulago Specialized Women and Neonatal Hospital, Kampala, Uganda.
Reprod Health. 2024 Jan 4;21(1):2. doi: 10.1186/s12978-023-01732-7.
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).
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.
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.
女性生殖器瘘是一种创伤性的使人虚弱的损伤，常由长时间的梗阻性分娩引起，在资源较少的环境中影响着 50 万至 200 万女性。膀胱阴道瘘导致尿失禁，瘘管发展过程中还可能出现其他发病率。患有瘘管的女性受到污名化，限制了她们的社会和经济参与，并经历精神疾病。手术机会的改善减少了瘘管的后果，但修复后的风险仍会影响生活质量和幸福感，包括瘘管修复失败或复发，以及持续或变化的尿漏或失禁。导致不良后果的危险因素的有限证据阻碍了减轻不良事件的干预措施。本研究旨在通过以下方式量化这些不良风险，并为临床和咨询干预措施提供信息，以优化女性瘘管修复后的健康和生活质量：确定修复后瘘管破裂和复发（目标 1）和修复后失禁（目标 2）的预测因素和特征，并确定可行且可接受的干预策略（目标 3）。
本混合方法研究纳入了在乌干达约 12 个瘘管修复中心成功进行膀胱阴道瘘修复的女性前瞻性队列（目标 1-2），随后对主要利益相关者进行定性研究（目标 3）。队列参与者将在手术时进行基线访视，然后在 2 周、6 周、3 个月和此后每季度进行数据收集，为期 3 年。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，这些因素将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、手术后 2 周以及症状出现时进行以确认结果。主要结局是瘘管修复失败或瘘管复发和修复后失禁。将对队列参与者（n ~ 40）和其他主要利益相关者（n ~ 40，包括家庭、同伴、社区成员和临床/社会服务提供者）进行深入访谈，以了解建议的可行性和可接受性。
参与者招募正在进行中。本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女性结局的关键预测因素，从而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的广泛研究。
ClinicalTrials.gov 标识符：NCT05437939。
