Abstract

This project will determine if tamsulosin is useful in patients with a kidney stone. Tamsulosin is used for patients with an enlarged prostate gland, but it has other effects, including relaxing the smooth muscle of the ureters. It is thought that through this mechanism tamsulosin may aid patients with kidney stones that are located in the ureters. This study builds on an earlier placebo controlled double blind trial performed at the George Washington University Hospital that successfully enrolled 109 patients with kidney stones. A further 391 patients will be recruited to that a total of 500 patients will be in the stuy. The sites for the study will be the emergency departments at The George Washington University, the Hospital of University of Pennsylvania and University of Pittsburgh. The primary outcome will be the number of patients who have passed the kidney stone by 30 days after diagnosis. We will also determine if the drug causes other benefits such as reduced pain, less time off work, and a reduced need for surgical intervention.

Public Health Relevance

Kidney stones affect about 10% of the population and result in over one million visits every year to the emergency department. Although many stones pass, all cause considerable pain and many require follow up visits to a urologist and surgical intervention. If tamsulosin is shown to increase the rate of stone passage and decrease surgical complications, it will be a major health benefit.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK096037-02
Application #
8535752
Study Section
Special Emphasis Panel (ZDK1-GRB-6 (M2))
Program Officer
Kusek, John W
Project Start
2012-09-01
Project End
2016-05-31
Budget Start
2013-06-01
Budget End
2014-05-31
Support Year
2
Fiscal Year
2013
Total Cost
$1,030,830
Indirect Cost
$120,661

  Institution

Name
George Washington University
Department
Emergency Medicine
Type
Schools of Medicine
DUNS #
043990498
City
Washington
State
DC
Country
United States
Zip Code
20052

  Publications

Meltzer, Andrew C; Burrows, Pamela Katzen; Wolfson, Allan B et al. (2018) Effect of Tamsulosin on Passage of Symptomatic Ureteral Stones: A Randomized Clinical Trial. JAMA Intern Med 178:1051-1057
Burrows, Pamela K; Hollander, Judd E; Wolfson, Allan B et al. (2017) Design and challenges of a randomized clinical trial of medical expulsive therapy (tamsulosin) for urolithiasis in the emergency department. Contemp Clin Trials 52:91-94
Meltzer, Andrew C; Michel, Chloe (2016) The Importance of an Accurate Diagnosis for Renal Colic. Ann Emerg Med 68:643-644
Reynolds, Joshua C; Grunau, Brian E; Rittenberger, Jon C et al. (2016) Association Between Duration of Resuscitation and Favorable Outcome After Out-of-Hospital Cardiac Arrest: Implications for Prolonging or Terminating Resuscitation. Circulation 134:2084-2094