Limited Competition for Continuation of RIVUR

膀胱输尿管反流是儿童泌尿道感染最常见的先天性畸形。如果未被识别和治疗，它可能会导致复发性UTI和肾瘢痕，这反过来又可能是高血压和肾功能不全的原因。大多数较低级别的VUR病例随着生长而消退，但这可能需要多年时间。治疗仍有争议，包括观察，长期抗生素预防和手术矫正。最近，已经开发了用于手术矫正的微创技术，这导致了更广泛的干预，这可能是不适当的或不必要的。到目前为止，治疗算法一直基于非随机、非对照研究或无统计相关性的试验。RIVUR（膀胱输尿管反流儿童随机干预）试验设计为双盲、随机、统计学相关研究，比较安慰剂与1个月至6岁年龄的I-IV级VUR儿童的长期抗生素预防。这是同类研究中唯一的一项。它最初于2005年获得资金，计划于2010年完成。随机化后，观察儿童2年。方案制定和放射学试点研究在最初的1年半内取得了进展;大多数临床研究中心在2007年启动。必须在许多临床地点修改放射成像技术以实现诊断准确性。统计学分析确定每组需要300例患者才能获得足够的统计学把握度。制定了严格的入选标准，特别是关于UTI的诊断和指标UTI与VUR放射学发现之间的时间。目前，只有不到400名患者接受了随机分组，因此RIVUR试验将延长至2013年。总部位于布法罗的联盟是5个临床中心之一，最初的任务是每个中心招募120名儿童。我们只是害羞的目标，我们已经招募了113名儿童，比任何其他临床中心。因此，我们被要求招收120名以上的学生，我们希望在2010年初开始这样做。预计RIVUR试验的数据将使VUR儿童能够得到适当的治疗和利用医疗保健资源。

Vesicoureteral reflux (VUR) is the most common congenital anomaly associated with urinary tract infection (UTI) in children. If unrecognized and untreated it can lead to recurrent UTI and renal scarring, which in turn can be the cause of hypertension and renal insufficiency. Most cases of lower grade VUR resolve with growth, but this can take many years. Treatment remains controversial and includes observation, long term antibiotic prophylaxis and surgical correction. More recently, minimally invasive techniques for surgical correction have been developed and this has led to more widespread intervention, which may not be appropriate or necessary. Until now treatment algorithms have been based on non-randomized, uncontrolled studies or trials without statistical relevance. The RIVUR (Randomized Intervention for children with Vesicoureteral Reflux) trial was designed as a double blind, randomized, statistically relevant study, comparing placebo to long term antibiotic prophylaxis in children with grades l-IV VUR in children 1 month to 6 years of age. It is the only study of its kind. It was initially funded in 2005 and meant to be completed in 2010. After randomization, children are observed for 2 years. Protocol development and radiologic pilot studies progressed over the first 1 1/2 years; most clinical sites were activated in 2007. Radiologic imaging techniques had to be modified at a number of clinical sites to achieve diagnostic accuracy. Statistical analysis determined that 300 patients were needed in each arm to achieve adequate statistical power. Strict entrance criteria were developed, especially regarding the diagnosis of UTI and timing between the index UTI and radiologic discovery of VUR. At present fewer than 400 patients have been randomized and it is for that reason that the RIVUR trial is being extended to 2013. The Buffalo-based consortium is one of 5 clinical centers that were initially tasked to enroll 120 children each. We are just shy of that goal and we have enrolled 113 children, more than any other, clinical center. Thus, we have been asked to enroll beyond 120, which we hope to begin doing early in 2010. It is anticipated that data from the RIVUR trial will enable appropriate treatment and utilization of health care resources for children with VUR.