Extension of Urinary Stone Disease Research Network (USDRN) at Washington University

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， 达到和维持高尿量的策略的有效性，以及这些策略是否 降低USD复发率。水化预防尿路结石（PUSH）研究是一项 一项研究液体摄入量增加和尿量增加的影响的随机临床试验 对成人和儿童USD复发率的影响。在这项研究中，1，642名参与者将 随机分配到对照组或干预组。两组的参与者都会收到一个“智能水瓶”。 干预部门包括一个额外的行为干预计划，包括金融干预。 激励措施、结构化的问题解决和低接触干预措施，旨在提高对 规定的液体摄入量。主要终点是在两个- 年观察期。PUSH研究已经进入第三年，由于面临多重挑战， 研究参与者的招募、参与者的随访和数据收集尚未完成。 完成需要额外的时间来确保研究完成并实现所有研究目标。 虽然输尿管支架术是泌尿外科手术后常规进行的USD，以减轻并发症， 手术并发症、支架引起患者明显不适。因果机制只是 部分理解。提高对支架相关症状认识的研究 是一项前瞻性观察性队列研究， 输尿管镜介入治疗输尿管和/或肾结石。参与者经历详细的症状 使用有效问卷进行评估，心理社会评估，定量感官测试 用于评价疼痛敏感性，并详细收集临床和手术数据。 正在收集生物标本（血液和尿液）用于未来的研究。支架招募 对参加者的研究和后续工作预计将按时完成。但是，额外的 分析收集的研究数据需要时间和资源。在本申请的目标1中， 研究者将继续并完成PUSH研究的受试者入组，继续 为NIDDK储存库收集生物标本，分析数据，并准备和提交几份 与研究假设相关的计划手稿。在本申请的目标2中，研究人员 将分析支架研究的数据，解释结果，并通过以下方式传播结果： 同行评审的出版物。

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.