Dataset from Study of Tamsulosin for Urolithiasis in the Emergency Department

Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In
the US there are over 1.1 million visits annually to Emergency Departments for renal colic.
The disease is extremely painful, often requiring large amounts of narcotic analgesia, and
results in lost work days. Moreover, up to 30% of patients may eventually require lithotripsy
or surgical removal of the stone. Currently there are no medical interventions other than
analgesia which are offered to patients.

Based on encouraging results from several small European clinical studies, the researchers
hypothesize that the administration of tamsulosin to patients with symptomatic urolithiasis
will enhance stone passage, and reduce both the time to recovery and the need for surgical
intervention or lithotripsy. The researchers will conduct a study by identifying and
recruiting patients presenting with urolithiasis in the emergency departments of four
institutions.

A total of 500 consenting subjects will be randomly assigned to one of two groups:

1. tamsulosin for a maximum of 28 days;

2. placebo for a maximum of 28 days.

In addition, both groups will receive standard analgesic therapy.

The study team, which will be blinded to treatment status, will monitor each subject's
clinical progress and outcome. The primary objectives of this study are:

1. to determine if tamsulosin is effective, and

2. to evaluate the safety of the therapy.

Another objective is to identify the most appropriate clinical subgroup(s) for treatment.

If the therapeutic benefits observed in smaller clinical studies are replicated,
administration of these medications should produce several benefits, including:

1. a reduction in time to pain free recovery and hence a more rapid return to employment;

2. decreased requirements for narcotic analgesia;

3. less need for urological out-patient clinic follow-up;

4. decreased need for surgical intervention or lithotripsy; and

5. substantial cost savings.

If this therapy is beneficial, it will represent a major advance in the treatment of
urolithiasis. This objective is a major stated goal of the NIDDK (National Institute of
Diabetes and Digestive and Kidney Diseases) Clinical Urology Program, which has a stated
mission to improve the treatment of urolithiasis.

Kidney stones are a major public health issue, and one person in eight will be affected by
the disease. If the hypothesis is verified, the researchers will provide the first medical
therapy ever for this disease. This therapy, if effective, will reduce the amount of time a
patient is off work because of the pain from the disease, and may also reduce the need for
expensive and time-consuming surgical treatments.

尿路结石症（Urolithiasis）是一种影响全球12%人口的疾病，且其发病率正逐年攀升。在美国，每年因肾绞痛前往急诊科就诊的人次超过110万。该疾病痛感剧烈，往往需要使用大量阿片类镇痛剂进行干预，还会导致患者误工。此外，多达30%的患者最终可能需要接受体外冲击波碎石术（lithotripsy）或手术取石。目前除镇痛治疗外，尚无其他针对该疾病的内科干预手段。

基于多项欧洲小型临床研究的喜人结果，研究人员提出假说：对有症状的尿路结石症患者给予坦索罗辛（tamsulosin）治疗，可促进结石排出，缩短患者康复时间，并减少手术干预或体外冲击波碎石术的需求。研究人员计划开展一项多中心临床研究，在四家医疗机构的急诊科中招募尿路结石症患者。

共计500名签署知情同意书的受试者将被随机分为两组：
1. 坦索罗辛治疗组，最长给药28天；
2. 安慰剂（placebo）对照组，最长给药28天。
两组受试者均将接受标准镇痛治疗。

研究团队将对治疗分配情况不知情（采用盲法设计），并对每位受试者的临床进程与转归进行监测。本研究的主要研究目标为：
1. 评估坦索罗辛的临床有效性；
2. 评价该治疗方案的安全性。
另一项研究目标为确定最适合接受该治疗的临床亚组人群。

若小型临床研究中观察到的治疗益处能够在本研究中得到复现，坦索罗辛治疗将为患者带来多重获益，包括：
1. 缩短无痛康复时间，从而更快重返工作岗位；
2. 减少阿片类镇痛剂的使用剂量；
3. 降低泌尿外科门诊随访的需求；
4. 减少手术干预或体外冲击波碎石术的必要性；
5. 显著节约医疗成本。

若该治疗方案确有疗效，将成为尿路结石症治疗领域的重大进展。这一目标也是美国国家糖尿病、消化和肾脏疾病研究所（National Institute of Diabetes and Digestive and Kidney Diseases, NIDDK）临床泌尿外科项目的核心既定目标，该机构的既定使命即为改善尿路结石症的临床治疗方案。

肾结石是一项重大的公共卫生问题，每8人中就有1人会受该疾病影响。若本研究验证了上述假说，将为尿路结石症带来首款内科治疗方案。该治疗手段若能生效，将缩短患者因疾病疼痛导致的误工时长，同时还可减少昂贵且耗时的外科治疗需求。