Fluid Therapy and Stent Management in Nephrolithiasis, USDRN extension

项目总结： 尿路结石病是一种日益流行且高度复发的疾病。 随着严重发病率的增加，社会成本不断上升。因此，改进管理可以显著减少 它的健康负担。建议所有美国患者增加液体摄入量。然而，知识 关于液体疗法在预防美元复发方面的影响，包括有效性，仍然存在分歧。 关于实现和保持高尿量的策略，以及这些策略是否会减少美元 复发。水化预防尿结石(PUSH)研究是一项随机临床试验 研究液体摄入量增加和尿量增加对糖尿病复发率的影响 美元，成人和儿童。在这项研究中，1642名参与者将被随机分配到对照组或 介入臂。两个手臂的参与者都会收到一个“智能水瓶”。介入臂涉及 一项额外的行为干预计划，包括经济激励、结构化问题 旨在改善对规定液体摄入量的依从性的解决和低接触干预措施 养生法。主要终点是在两年的观察期内发生石块事件。 PUSH研究已进入第三个年头，由于招募研究参与者面临多重挑战， 参与者的后续行动和数据收集尚未完成。需要额外的时间来 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 为了减少围手术期并发症，支架引起的并发症 严重的病人不适。人们对其中的因果机制只有部分了解。这项研究旨在 提高对支架相关症状(支架)的认识是一个前瞻性的观察 青少年和成人接受输尿管镜介入治疗和/或输尿管的队列研究 肾结石。参与者使用经过验证的问卷进行详细的症状评估，a 心理社会评估，用于评估疼痛敏感化的定量感觉测试，以及详细的 临床和手术数据的收集。正在收集生物制品(血液和尿液)以备将来使用。 研究。支架研究的招募和参与者的随访预计将是 按时完工。然而，需要额外的时间和资源来分析收集到的研究 数据。在本申请的目标1中，调查人员将继续并完成以下参与者的登记 推送研究，继续为NIDDK存储库收集生物量，分析数据，以及 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 通过同行评议的出版物传播调查结果。

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 application, the investigators will analyze the data from the STENTS studies, interpret findings, and disseminate findings through peer reviewed publications.