Fluid Therapy and Stent Management in Nephrolithiasis, USDRN extension

项目摘要： 泌尿系结石病（USD）是一种日益流行和高度复发的疾病， 严重的发病率给社会带来的代价越来越高。因此，改善管理可以大大减少 健康负担。建议所有USD患者增加液体摄入量。然而，知识 关于液体治疗在预防USD复发方面的影响，包括有效性， 实现和维持高尿量的策略，以及此类策略是否可以减少美元 复发水化预防尿路结石（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复发率的影响， 成人和儿童美元。在这项研究中，1，642名参与者将被随机分配到对照组或 两组的参与者都收到一个“智能水瓶”。干预臂涉及 一个额外的行为干预计划，包括经济激励，结构化问题， 解决问题，以及旨在提高对规定液体摄入量的依从性的低接触干预措施 方案.主要终点是在两年观察期内发生结石事件。 PUSH研究已经进入第三年，由于招募研究参与者面临多重挑战， 对参与者的后续行动和数据收集工作尚未完成。需要更多的时间来 确保完成研究并实现所有研究目标。虽然输尿管支架植入术是常规的 在USD的泌尿外科手术后进行，以减轻围手术期并发症，支架引起 患者明显不适。因果机制只被部分理解。书房 加强对支架相关症状的了解（支架）是一项前瞻性观察性研究， 一项队列研究，入组了接受输尿管镜介入治疗的青少年和成人， 肾结石参与者使用有效的问卷进行详细的症状评估， 心理社会评估，定量感觉测试，用于评估疼痛敏感性，以及详细的 收集临床和手术数据。正在收集生物标本（血液和尿液），以备将来使用。 research.预计支架研究的招募和参与者的随访将 按时完成。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，研究者将继续并完成受试者入组， PUSH研究，继续为NIDDK储存库收集生物标本，分析数据， 准备并提交几份与研究假设相关的计划手稿。目标2 应用程序，研究者将分析支架研究的数据，解释结果， 通过同行审查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.