Fluid Therapy and Stent Management in Nephrolithiasis, USDRN extension

肾结石的液体治疗和支架管理，USDRN 扩展

• 批准号: 10707884
• 负责人: NAIM M MAALOUF
• 金额: $ 59.61万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10707884
• 关键词: Address; Adherence; Adolescent; Adult; Behavior Therapy; Behavioral; Biological; Blood; COVID-19; COVID-19 pandemic; Caring; Child; Childhood; Clinic; Clinical; Clinical Research; Collection; Communities; Data; Data Collection; Deposition; Disease; Effectiveness; Endocrinologist; Enrollment; Ensure; Event; Excision; Fluid Therapy; Foundations; Funding; Future; Goals; Health; Hydration status; Individual; Institution; Intake; Intervention; Interview; Investigation; Kidney; Kidney Calculi; Knowledge; Lifting; Liquid substance; Manuscripts; Measures; Medical; Medicine; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Nephrolithiasis; Obstruction; Operative Surgical Procedures; Output; Pain; Participant; Patient Care; Patient Recruitments; Patients; Pediatric Hospitals; Peer Review; Pennsylvania; Perioperative complication; Philadelphia; Plasma; Prevalence; Prevention; Problem Solving; Procedures; Prospective, cohort study; Psychosocial Assessment and Care; Public Health; Publications; Questionnaires; Randomized; Recommendation; Recurrence; Recurrent disease; Regimen; Reporting; Research; Research Design; Research Institute; Research Personnel; Resources; Safety; Sampling; Science; Scientist; Sensory; Serum; Site; Societies; Stents; Structure; Symptoms; Texas; Thinness; Time; Touch sensation; Tube; Universities; Ureter; Ureteroscopy; Urinary Calculi; Urine; Urologist; Visit; Washington; Water; Whole Blood; arm; associated symptom; clinical care; clinical center; cohort; cost; design; effectiveness evaluation; electronic consent; evaluation/testing; experience; financial incentive; follow-up; health care service utilization; improved; innovation; insight; multidisciplinary; novel; observational cohort study; participant enrollment; prevent; primary endpoint; programs; prospective; radiologist; randomized, clinical trials; recruit; repository; response; success; therapy design; treatment arm; urinary; urologic; virtual visit

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.

项目概要： 尿路结石病 (USD) 是一种日益普遍且高度复发的疾病，与 发病率高，社会成本不断上升。因此，改进管理可以显着减少 它的健康负担。建议所有 USD 患者增加液体摄入量。然而，知识 关于液体疗法在预防 USD 复发方面的影响（包括有效性）仍然存在差距 实现和维持高尿量的策略，以及这些策略是否会减少美元 复发。通过水合预防尿路结石 (PUSH) 研究是一项随机临床试验 研究增加液体摄入量和增加尿量对复发率的影响 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对照组 干预臂。参与者的双臂都会收到一个“智能水瓶”。干预臂涉及 额外的行为干预计划，包括经济激励、结构化问题 解决问题和低接触干预措施，旨在提高对规定液体摄入量的依从性 养生法。主要终点是两年观察期内结石事件的发生。 PUSH 研究已进入第三年，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 确保学习完成并实现所有学习目标。虽然输尿管支架置入术是常规治疗 在 USD 泌尿外科手术后进行，以减轻围手术期并发症、支架引起的并发症 患者明显不适。因果机制仅被部分了解。该研究旨在 增强对支架相关症状 (STENTS) 的理解是一项前瞻性观察研究 队列研究招募青少年和成人接受输尿管镜介入治疗输尿管和/或 肾结石。参与者使用经过验证的问卷进行详细的症状评估， 心理社会评估、用于评估疼痛敏感性的定量感觉测试以及详细的 收集临床和手术数据。正在收集生物样本（血液和尿液）以供将来使用 研究。 STENTS 研究的招募和参与者的随访预计将在 按时完成。然而，需要额外的时间和资源来分析收集的研究 数据。在本申请的目标 1 中，研究人员将继续并完成参与者登记 PUSH 研究，继续为 NIDDK 存​​储库收集生物样本，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 应用程序中，研究人员将分析支架研究的数据，解释结果，并 通过同行评审出版物传播研究结果。

项目成果

Quality of life impact and recovery after ureteroscopy and stent insertion: insights from daily surveys in STENTS.

• DOI: 10.1186/s12894-022-01004-9
• 发表时间: 2022-04-06
• 期刊: BMC urology
• 影响因子: 2
• 作者: Harper JD;Desai AC;Antonelli JA;Tasian GE;Ziemba JB;Al-Khalidi HR;Lai HH;Maalouf NM;Reese PP;Wessells HB;Kirkali Z;Scales CD Jr;NIDDK Urinary Stone Disease Research Network (USDRN)
• 通讯作者: NIDDK Urinary Stone Disease Research Network (USDRN)