Effectiveness and acceptability of two insertable device models for non-surgical management of obstetric fistula in Ghana: a randomized crossover trial

加纳产科瘘管非手术治疗的两种可插入装置模型的有效性和可接受性：一项随机交叉试验

• 批准号: 10596641
• 负责人: Alison M El Ayadi
• 金额: $ 34.12万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10596641
• 关键词: Address; Adherence; Africa South of the Sahara; Atopobium vaginae; Caring; Clinical; Clinical Trials; Collection; Communities; Community Health Aides; Consolidated Framework for Implementation Research; Cross-Over Trials; Crossover Design; Data; Device Designs; Devices; Direct Costs; Discipline of obstetrics; Economic Burden; Economics; Effectiveness; Epidemiology; Extravasation; Face; Facilities and Administrative Costs; Feasibility Studies; Fistula; Future; Ghana; Goals; Health behavior; Home; Incontinence; Individual; International; Intervention; Intervention Studies; Interview; Leg; Longitudinal Surveys; Measures; Medical; Methods; Midwife; Modeling; Modification; Motion; Nurses; Operative Surgical Procedures; Participant; Patient Outcomes Assessments; Patient Self-Report; Patients; Practice Management; Prevention; Process; Productivity; Provider; Quality of life; Randomized; Reporting; Research; Resources; Risk Reduction; Rubber; Secure; Self Efficacy; Silicones; Site; Social Impacts; Surveys; Testing; Textiles; Therapeutic; Time; Time and Motion Studies; Tube; Urinary Fistula; Urinary Incontinence; Urine; Vagina; Woman; Work; clinical practice; comparative effectiveness; coping; cost; cost effective; cost effectiveness; design; economic impact; effectiveness evaluation; effectiveness measure; evidence base; follow-up; health economics; implementation research; implementation science; implementation strategy; implementation study; improved; low and middle-income countries; maternal morbidity; microcosting; obstetric fistula; opportunity cost; peer; prototype; repaired; social stigma; socioeconomics; standard of care; tertiary prevention; theories; time use; uptake; urinary

PROJECT SUMMARY Obstetric fistula is a traumatic maternal morbidity resulting in severe urinary incontinence that increases stigma and reduces quality of life. The two million women with fistula, most in sub-Saharan Africa, face substantial multi- level barriers to surgical repair. Women need an acceptable non-surgical option for therapeutic management of fistula-related urinary incontinence, yet no non-surgical standard of care exists. Use of an insertable silicone vaginal cup has great potential for fistula management; it is effective for menstrual management and efficacious at reducing short-term fistula urinary leakage. We propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup (‘cup’), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag (‘cup+’) for greater urine holding capacity. Using a cross-over design for efficiency, 100 participants will be randomized to one of two sequences of leaking freely, cup, and cup+ at two fistula care centers in Ghana and observed for four days (total observations=400). Each treatment (cup, cup+ or leaking freely) is used for 24h for day and night use, then crossover. Data are captured through self-report and clinical checklist. On day 4, participants are re-randomized to use cup or cup+ at home for 3 months. Acceptability assessment is informed by implementation and health behavior theory. Aim 1. To quantify the effectiveness and comparative effectiveness of the cup and cup+. The trial will compare objective and patient-reported measures of effectiveness of the cup and cup+ to leaking freely and of the cup to the cup+. Short-term assessment will be objective (urinary leakage; 8, 24hrs), long-term assessment will be patient-reported (QoL; 1-3 months). Aim 2. To examine acceptability of cup and cup+. User and implementer acceptability will be assessed using a sequential explanatory mixed-methods design. Acceptability among trial participants will be measured longitudinally (1-3 months). User and implementer acceptability will be examined within in-depth interviews of selected trial participants (n~30) at 3 months and potential implementers (ob/gyns, midwives/nurses, community health workers, n~20). Aim 3. To explore the material and opportunity costs to non-surgical fistula management. Surveys and time motion study among trial participants at facility and community will estimate direct and indirect costs of fistula management from a patient perspective. The long-term goal of the proposed work is to overcome barriers to comprehensive fistula care and increase quality of life through an acceptable, non-surgical option for therapeutic management of fistula.

项目概要 产科瘘是一种创伤性孕产妇疾病，可导致严重尿失禁，增加耻辱感 200 万患有瘘管病的妇女（大多数生活在撒哈拉以南非洲地区）面临着巨大的多重挑战。 女性需要一个可接受的非手术屏障来进行治疗。 治疗瘘管相关的尿失禁，但尚无非手术护理标准。 可插入的硅胶阴道杯对于瘘管管理具有巨大的潜力，对月经有效； 管理并有效减少短期瘘管漏尿。我们提出了一项临床试验和嵌套试验。 定性研究 1) 量化可插入阴道杯管理尿瘘的有效性 失禁，2) 检查用户和实施者的可接受性，以及 3) 量化瘘管管理成本。 将在等待瘘管手术或已接受手术的女性中比较两种干预模型 不成功：1) 阴道杯（“杯子”），2) 通过橡胶管将杯子连接到腿部固定的尿液收集器 袋子（“cup+”）具有更大的尿液容纳能力，采用交叉设计以提高效率，将容纳 100 名参与者。 在加纳的两个瘘管护理中心随机分配至自由渗漏、cup 和 cup+ 两个序列之一 观察四天（观察总数=400），每次处理（杯、杯+或自由泄漏）使用24小时。 白天和晚上使用，然后通过自我报告和临床检查表收集数据。 参与者被重新随机在家使用 cup 或 cup+ 3 个月。 通过实施和健康行为理论 目标 1. 量化有效性和比较。 该试验将比较cup 和cup+ 的客观测量值和患者报告的测量值。 杯子和杯子+对自由泄漏以及杯子对杯子+的有效性将进行短期评估。 目标（漏尿；8、24 小时），长期评估将由患者报告（生活质量；1-3 个月）。 为了检查 cup 和 cup+ 的可接受性，将使用 a 来评估用户和实施者的可接受性。 将测量试验参与者的顺序解释性混合方法设计。 将在深入访谈中纵向（1-3 个月）检查用户和实施者的可接受性。 选择 3 个月时的试验参与者（n~30）和潜在实施者（妇产科医生、助产士/护士、社区 卫生工作者，n~20) 目标 3. 探讨非手术瘘管的材料和机会成本。 设施和社区的试验参与者之间的调查和时间动态研究将进行估计。 从患者的角度来看，瘘管治疗的直接和间接成本 拟议的长期目标。 工作的目的是克服全面瘘管病护理的障碍，并通过可接受的、 瘘管治疗的非手术选择。