Harnessing Behavior to Decrease Urinary Stone Disease Morbidity Research Project

项目总结 尿路结石病是一种日益流行和高度复发的疾病，与主要 发病率不断上升，给社会带来了成本。因此，改善管理可以显著减轻其健康负担。 建议所有美国患者增加液体摄入量。然而，关于以下方面的知识差距仍然存在 液体疗法在预防美元复发中的影响，包括实现和 保持较高的尿量，以及这些策略是否减少了美元兑美元的复发。预防尿失禁 结石与水化(PUSH)研究是一项随机临床试验，调查液体增加的影响 摄入量和尿量增加对成人和儿童尿崩症复发率的影响。在这项研究中，有1642人 参与者将被随机分配到对照组或干预组。双臂参赛的人都会得到一杯“智能水” 瓶子“。干预部门涉及一项额外的行为干预计划，包括金融干预 激励、结构化问题解决和低接触干预，旨在提高对 规定的液体摄入方案。主要终点是在两年内发生石块事件 观察期。PUSH研究已进入第三个年头，由于招生工作面临多重挑战 参与者、参与者的后续行动和数据收集尚未完成。需要更多的时间 确保完成学习并完成所有学习目标。尽管输尿管支架置入术是常规的 在为减少围手术期并发症而进行的泌尿外科手术后，支架对患者造成重大影响。 不舒服。人们对其中的因果机制只有部分了解。为加强对支架的认识而进行的研究- 相关症状(支架)是一项招募青少年和成人的前瞻性观察性队列研究 接受输尿管镜介入治疗输尿管和/或肾结石。参与者会经历详细的症状 使用有效的问卷进行评估，心理社会评估，定量感觉测试 评估疼痛敏感度，并详细收集临床和手术数据。生物制品(血液和 尿液)正在收集中，以供将来研究。对支架研究的招募和参与者的随访 预计将按时完工。然而，需要额外的时间和资源来分析 收集研究数据。在本申请的目标1中，调查人员将继续并完成参与者 注册PUSH研究，继续为NIDDK存储库收集生物样品，分析数据， 并准备并提交几份与研究假设相关的计划手稿。在这个目标2中 应用，调查人员将分析支架研究的数据，解释发现，并传播 通过同行评议出版物的调查结果。

PROJECT SUMMARY Urinary Stone Disease (USD) is an increasingly prevalent and highly recurrent condition associated with major morbidity at a rising cost to society. Thus, improved management can significantly reduce its health burden. Increasing fluid intake is recommended to all USD patients. However, knowledge gaps persist regarding the impact of fluid therapy in preventing USD recurrence including effectiveness of strategies to achieve and maintain a high urine volume, and whether such strategies reduce USD recurrence. The Prevention of Urinary Stones with Hydration (PUSH) study is a randomized clinical trial investigating the impact of increased fluid intake and increased urine output on the recurrence rate of USD in adults and children. In this study 1,642 participants will be randomized to a control or intervention arm. Participants in both arms receive a “smart water bottle”. The intervention arm involves an additional program of behavioral interventions, including financial incentives, structured problem solving, and low touch interventions designed to improve adherence to a prescribed fluid intake regimen. The primary endpoint is occurrence of a stone event during a two-year observation period. The PUSH study is in its third year, and due to multiple challenges to recruitment of study participants, follow-up of participants and data collection have not yet been completed. Additional time is needed to ensure study completion and to accomplish all study goals. Although ureteral stenting is routinely performed after urological procedures for USD to mitigate peri-operative complications, stents cause significant patient discomfort. The causal mechanisms are only partly understood. The STudy to Enhance uNderstanding of sTent- associated Symptoms (STENTS) is a prospective observational cohort study enrolling adolescents and adults undergoing ureteroscopic intervention for ureteral and/or renal stones. Participants undergo detailed symptom assessment using validated questionnaires, a psychosocial assessment, quantitative sensory testing for evaluation of pain sensitization, and detailed collection of clinical and operative data. Biospecimens (blood and urine) are being collected for future research. Recruitment to the STENTS study and follow-up of the participants are expected to be completed on time. However, additional time and resources are needed for analysis of collected study data. In Aim 1 of this application, the investigators will continue and complete participant enrollment for the PUSH study, continue biospecimen collection for the NIDDK Repository, analyze the data, and prepare and submit several planned manuscripts related to the study hypotheses. In Aim 2 of this applications, the investigators will analyze the data from the STENTS studies, interpret findings, and disseminate findings through peer reviewed publications.