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
基本信息
- 批准号:10596641
- 负责人:
- 金额:$ 34.12万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AddressAdherenceAfrica South of the SaharaAtopobium vaginaeCaringClinicalClinical TrialsCollectionCommunitiesCommunity Health AidesConsolidated Framework for Implementation ResearchCross-Over TrialsCrossover DesignDataDevice DesignsDevicesDirect CostsDiscipline of obstetricsEconomic BurdenEconomicsEffectivenessEpidemiologyExtravasationFaceFacilities and Administrative CostsFeasibility StudiesFistulaFutureGhanaGoalsHealth behaviorHomeIncontinenceIndividualInternationalInterventionIntervention StudiesInterviewLegLongitudinal SurveysMeasuresMedicalMethodsMidwifeModelingModificationMotionNursesOperative Surgical ProceduresParticipantPatient Outcomes AssessmentsPatient Self-ReportPatientsPractice ManagementPreventionProcessProductivityProviderQuality of lifeRandomizedReportingResearchResourcesRisk ReductionRubberSecureSelf EfficacySiliconesSiteSocial ImpactsSurveysTestingTextilesTherapeuticTimeTime and Motion StudiesTubeUrinary FistulaUrinary IncontinenceUrineVaginaWomanWorkclinical practicecomparative effectivenesscopingcostcost effectivecost effectivenessdesigneconomic impacteffectiveness evaluationeffectiveness measureevidence basefollow-uphealth economicsimplementation researchimplementation scienceimplementation strategyimplementation studyimprovedlow and middle-income countriesmaternal morbiditymicrocostingobstetric fistulaopportunity costpeerprototyperepairedsocial stigmasocioeconomicsstandard of caretertiary preventiontheoriestime useuptakeurinary
项目摘要
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
产科瘘管病是一种创伤性的孕产妇疾病,导致严重的尿失禁,增加了耻辱
并降低生活质量。200万患有瘘管病的妇女,大多数在撒哈拉以南非洲,面临着大量的多方面的治疗。
为手术修复提供了障碍。女性需要一种可接受的非手术治疗选择,
瘘管相关性尿失禁的管理,但没有非手术护理标准存在。使用
可插入的硅胶阴道杯具有巨大的瘘管管理潜力;它对月经有效
管理和有效减少短期瘘尿漏。我们提出了一个临床试验和嵌套
定性研究:1)量化可插入阴道杯管理尿瘘的有效性
失禁,2)检查使用者和实施者可接受性,和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失败的妇女中进行比较。
不成功的:1)阴道杯(“杯”),2)通过橡胶管连接到腿固定尿液收集杯
袋('杯+')更大的尿液容纳能力。为了提高效率,将采用交叉设计,
在加纳的两个瘘管护理中心,随机分配至两个泄漏序列之一:自由泄漏、杯状泄漏和杯状泄漏+,
观察四天(观察总数= 400)。每次治疗(杯、杯+或自由泄漏)使用24小时,
白天和晚上使用,然后交叉。通过自我报告和临床检查表获取数据。在第四天,
参与者被重新随机分配在家使用Cup或Cup +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.量化的有效性和比较
杯子和杯子+的有效性。该试验将比较客观和患者报告的指标,
杯和杯+的有效性,以自由泄漏和杯杯的杯+。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cup和cup+的可接受性。使用者和实施者的可接受性将使用
序贯解释混合方法设计将测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以下人员的深入访谈中进行检查:
3个月时选定的试验参与者(n~30)和潜在实施者(产科医生/妇科医生、助产士/护士、社区
卫生工作者,n~20)。目标3。探讨非手术瘘管的物质成本和机会成本
管理在设施和社区的试验参与者中进行调查和时间运动研究将估计
从病人的角度来看瘘管病管理的直接和间接费用。拟议的长期目标
我们的工作是克服全面瘘管病护理的障碍,
瘘管治疗管理的非手术选择。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Alison M El Ayadi其他文献
User Acceptability and Perceived Impact of a Mobile Interactive Education and Support Group Intervention to Improve Postnatal Health Care in Northern India: A Qualitative Study
移动互动教育和支持团体干预改善印度北部产后保健的用户接受度和感知影响:定性研究
- DOI:
10.21203/rs.3.rs-3320095/v1 - 发表时间:
2023 - 期刊:
- 影响因子:0
- 作者:
Valentina Cox;Preetika Sharma;Garima Singh Verma;Navneet Gill;Nadia G Diamond;Mona Duggal;Vijay Kumar;Rashmi Bagga;Jasmeet Kaur;Pushpendra Singh;Alison M El Ayadi - 通讯作者:
Alison M El Ayadi
Alison M El Ayadi的其他文献
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{{ truncateString('Alison M El Ayadi', 18)}}的其他基金
Prevalence and correlates of adverse pregnancy outcomes following female genital fistula repair in Uganda: a mixed-methods study
乌干达女性生殖器瘘修复术后不良妊娠结局的患病率和相关性:一项混合方法研究
- 批准号:
10289053 - 财政年份:2021
- 资助金额:
$ 34.12万 - 项目类别:
Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair
确定预防女性生殖器瘘修复术后不良后果的机会
- 批准号:
10561711 - 财政年份:2021
- 资助金额:
$ 34.12万 - 项目类别:
Prevalence and correlates of adverse pregnancy outcomes following female genital fistula repair in Uganda: a mixed-methods study
乌干达女性生殖器瘘修复术后不良妊娠结局的患病率和相关性:一项混合方法研究
- 批准号:
10455568 - 财政年份:2021
- 资助金额:
$ 34.12万 - 项目类别:
Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair
确定预防女性生殖器瘘修复术后不良后果的机会
- 批准号:
10398810 - 财政年份:2021
- 资助金额:
$ 34.12万 - 项目类别:
Prevalence and correlates of adverse pregnancy outcomes following female genital fistula repair in Uganda: a mixed-methods study
乌干达女性生殖器瘘修复术后不良妊娠结局的患病率和相关性:一项混合方法研究
- 批准号:
10622974 - 财政年份:2021
- 资助金额:
$ 34.12万 - 项目类别:
Comprehensive Reintegration Assistance for Women with Obstetric Fistula
为患有产科瘘的妇女提供全面的重返社会援助
- 批准号:
9924584 - 财政年份:2018
- 资助金额:
$ 34.12万 - 项目类别:
Comprehensive Reintegration Assistance for Women with Obstetric Fistula
为患有产科瘘的妇女提供全面的重返社会援助
- 批准号:
9013324 - 财政年份:2016
- 资助金额:
$ 34.12万 - 项目类别:
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