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.

项目摘要 产科瘘是一种创伤性的发病率，导致严重的尿失禁，增加了污名 并降低生活质量。两百万患有瘘管的妇女，大多数在撒哈拉以南非洲，面临着大量的多种多样的 手术修复的水平障碍。妇女需要一种可接受的非手术治疗选择 瘘管相关尿失禁的管理，但没有非手术标准的护理标准。使用 可插入的硅胶杯具有瘘管管理的巨大潜力。它对月经有效 管理和有效减少短期瘘管尿液泄漏。我们提出了一项临床试验并嵌套了 定性研究至1）量化可插入的阴道杯的有效性管理瘘管尿液 尿失禁，2）检查用户和实施者的可接受性，3）量化瘘管管理成本。 在等待瘘管手术或手术的女性中，将比较两种干预模型 失败：1）阴道杯（“杯”），以及2）通过橡胶管连接到腿部安全的尿液收集的杯子 袋子（'Cup+'），以增加尿液的能力。使用跨界设计以提高效率，将有100名参与者 在加纳的两个瘘管护理中心中随机分为两个漏漏，杯子和杯子+的序列之一 观察到四天（总观测= 400）。每种治疗（杯子，杯+或自由泄漏）用于24小时 日夜使用，然后跨越。数据是通过自我报告和临床清单捕获的。在第4天， 参与者被重新融合到在家中使用杯子或杯子+ 3个月。可接受性评估已通知 通过实施和健康行为理论。目标1。量化有效性和比较 杯子和杯子+的有效性。该试验将比较目标和患者报告的措施 杯子和杯子+的有效性，可以泄漏并将杯子泄漏到杯子+。短期评估将是 目的（尿液泄漏； 8、24小时），长期评估将是患者报告的（QOL； 1-3个月）。目标2。 检查杯子和杯子+的可接受性。用户和实施者的可接受性将使用 顺序挖掘的混合方法设计。试验参与者的可接受性将被衡量 纵向（1-3个月）。将在深入的访谈中检查用户和实施者的可接受性 在3个月和潜在的实施者（ob/gyns，助产士/护士，社区 卫生工作者，n〜20）。目标3。探索非手术瘘的材料和机会成本 管理。设施和社区的试用参与者之间的调查和时间运动研究将估计 从患者的角度来看，瘘管管理的直接和间接成本。拟议的长期目标 工作是要克服全面瘘管护理的障碍，并通过可接受的， 瘘管治疗管理的非手术选择。