Randomized Intervention for Vesico-Ureteral Reflux (RIV*

膀胱输尿管反流的随机干预 (RIV*

• 批准号: 7127268
• 负责人: RANJIV I MATHEWS
• 金额: $ 8.33万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7127268
• 关键词: antiinfective agents; biomaterials; chemoprevention; child (0-11); clinical research; clinical trials; cooperative study; disease /disorder prevention /control; human subject; human therapy evaluation; injury; kidney disorder; longitudinal human study; patient oriented research; pediatric pharmacology; pediatrics; relapse /recurrence; scars; urinary bladder disorder; urinary tract imaging /visualization; urinary tract infection; urinary tract surgery

DESCRIPTION (provided by applicant): Vesico-ureteral reflux (VUR) is a common condition seen among children with urinary tract infection (UTI). VUR is associated with serious conditions including acute pyelonephritis and permanent renal injury, leading to scarring, renal impairment ("reflux nephropathy") and end-stage renal disease. However, the optimal treatment for VUR remains unclear. Both prophylactic antibiotics and surgical correction have been widely implemented for management of children with VUR, but neither of these has been shown in prospective randomized trials to be superior in outcomes to surveillance, and both may have significant risks. The proposed research will identify the optimal initial management approach for children diagnosed with VUR, by comparing non-intervention (surveillance), prophylactic antibiotics, and surgical correction (endoscopic injection of bulking agent) in a prospective, randomized trial. In a multi-center collaboration of five clinical treatment centers and one data center, over 2 years we will enroll 600 patients with VUR (ages 10 years or less), and follow them for 2.5-4.5 years. This study will identify differences in incidence of UTI, reflux nephropathy, and other outcomes. The Brady Urological Institute and the Division of Pediatric Nephrology at Johns Hopkins Hospital are uniquely suited to the execution of the proposed research, with an integrated multi-disciplinary research team, extensive experience in the design and execution of multi-center clinical research, and substantive clinical caseload and experience in treatment of children with VUR. Much of the current management of VUR is based on case series and anecdotes. The information gained from this research has the potential to dramatically change clinical practice, by providing definitive evidence of the optimal initial management of children with VUR. Urinary tract infections in children account for over a million doctor visits per year, and 30,000-40,000 hospitalizations per year. Many of these children have vesico-ureteral reflux (a condition where urine improperly flows backwards out of the bladder toward the kidney), and this may predispose these children to urinary infections. While vesico-ureteral relux [sic] can be corrected surgically, it is unclear whether this is beneficial; this research study will compare several management approaches to vesicoureteral reflux to determine which is best

描述（由申请人提供）： 膀胱输尿管反流 (VUR) 是尿路感染 (UTI) 儿童的常见病症。 VUR 与严重疾病有关，包括急性肾盂肾炎和永久性肾损伤，导致疤痕、肾功能损害（“反流性肾病”）和终末期肾病。然而，VUR 的最佳治疗方案仍不清楚。预防性抗生素和手术矫正已广泛用于治疗 VUR 儿童，但前瞻性随机试验并未显示这两种方法的结果优于监测，并且两者都可能存在重大风险。拟议的研究将通过在一项前瞻性随机试验中比较不干预（监测）、预防性抗生素和手术矫正（内镜下注射填充剂）来确定诊断为 VUR 的儿童的最佳初始治疗方法。在五个临床治疗中心和一个数据中心的多中心合作中，我们将在两年多的时间里招募 600 名 VUR 患者（年龄不超过 10 岁），并对他们进行 2.5-4.5 年的随访。这项研究将确定尿路感染、反流性肾病和其他结果的发生率差异。约翰·霍普金斯医院的布雷迪泌尿外科研究所和儿科肾病科非常适合执行拟议的研究，拥有综合的多学科研究团队、在多中心临床研究的设计和执行方面的丰富经验以及实质性的研究成果。儿童 VUR 的临床病例数和治疗经验。目前 VUR 的大部分管理都是基于病例系列和轶事。从这项研究中获得的信息有可能极大地改变临床实践，为 VUR 儿童的最佳初始治疗提供明确的证据。 儿童尿路感染每年导致超过 100 万人次就诊，每年有 30,000-40,000 人次住院。这些儿童中的许多人患有膀胱输尿管反流（尿液不正常地从膀胱回流到肾脏的情况），这可能使这些儿童容易患泌尿道感染。虽然膀胱输尿管反流[原文如此]可以通过手术纠正，但尚不清楚这是否有益；这项研究将比较几种治疗膀胱输尿管反流的方法，以确定哪种方法最好