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

项目总结 产科瘘是一种创伤性母体疾病，导致严重的尿失禁，增加耻辱。 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，面临着相当多的 平整外科修复的障碍。女性需要一种可接受的非手术治疗选择 治疗瘘管相关性尿失禁，但不存在非手术护理标准。使用 可插入式硅胶阴道杯有很大的潜力用于瘘管治疗；它对月经有效 治疗和减少短期尿瘘的有效方法。我们建议进行一项临床试验并嵌套 定性研究：1)量化可插入式阴道杯治疗尿瘘的有效性 大小便失禁，2)检查使用者和实施者的可接受性，3)量化瘘管管理成本。 两种干预模式将在等待瘘管手术或手术已完成的女性中进行比较 不成功：1)阴道杯(‘杯’)，和2)杯子通过橡胶管固定在腿上的尿液收集 袋子(‘杯+’)，可容纳更多的尿液。使用交叉设计以提高效率，100名参与者将 在加纳和加拿大的两个瘘管护理中心，随机分为两个漏液序列之一，杯子和杯子+ 观察4天(共观察400次)。每种治疗(杯子、杯子+或自由渗漏)使用24小时 白天和晚上使用，然后交叉使用。数据是通过自我报告和临床检查表获取的。在第四天， 参与者被重新随机分配到家里使用杯子或杯子+，为期3个月。告知可接受性评估 通过实施和健康行为理论。目标1.量化有效性和可比性 奖杯和奖杯+的效力。这项试验将比较客观和患者报告的测量结果 杯子和杯子+对自由渗漏和杯子对杯子+的效力。短期评估将是 目的(尿漏；8，24小时)，长期评估将由患者报告(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 序贯解释性混合方法设计。将衡量试验参与者的可接受性 纵向(1-3个月)。用户和实施者的可接受性将在深入访谈中进行检查 3个月时选定的试验参与者(n~30人)和潜在的实施者(妇产科医生、助产士/护士、社区 卫生工作者，n~20)。目的3.探讨非手术瘘管的材料成本和机会成本 管理层。在设施和社区的试验参与者中进行的调查和时间运动研究将估计 从患者的角度看瘘管治疗的直接和间接成本。建议的长期目标是 工作是克服全面瘘管护理的障碍，通过可接受的、 非手术治疗瘘管的选择。

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.