Harnessing Behavior to Decrease Urinary Stone Disease Morbidity Research Project

项目摘要 泌尿系结石病（USD）是一种日益普遍和高度复发的疾病，与主要的泌尿系疾病有关。 社会成本不断上升。因此，改善管理可以大大减轻其健康负担。 建议所有USD患者增加液体摄入量。然而，在以下方面仍然存在知识差距： 液体治疗对预防USD复发的影响，包括实现和 保持高尿量，以及这些策略是否会减少USD复发。预防尿 结石与水化（PUSH）研究是一项随机临床试验，研究液体增加的影响 摄入量和尿量增加对成人和儿童USD复发率的影响。在这项研究中，1，642 参与者将被随机分配到对照组或干预组。两组的参与者都将获得一种“智能水”， 瓶子”。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，以及旨在提高遵守 规定的液体摄入方案。主要终点是两年内发生结石事件 观察期。PUSH研究已进入第三年，由于研究招募面临多重挑战， 对参与者的跟踪和数据收集工作尚未完成。需要更多的时间 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手术， 在USD的泌尿外科手术以减轻围手术期并发症后，支架引起显著的患者 不适因果机制只被部分理解。加强对sTent的理解的研究- 相关症状（STENTS）是一项前瞻性观察性队列研究，招募了青少年和成人 因输尿管和/或肾结石接受输尿管镜介入治疗。参与者经历详细的症状 评估使用有效的问卷，心理社会评估，定量感官测试， 评估疼痛敏感性，并详细收集临床和手术数据。生物样本（血液和 尿液）被收集用于未来的研究。支架研究招募和参与者随访 预计将按时完成。然而，需要更多的时间和资源来分析 收集研究数据。在本申请的目标1中，研究者将继续完成参与者 入组PUSH研究，继续为NIDDK储存库采集生物标本，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 研究人员将分析支架研究的数据，解释结果，并传播 通过同行评审的出版物得出结论。

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.