Tamsulosin for Urolithiasis in the Emergency Dept

Study Summary

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 the

Primary Outcome

Hypothesis: The administration of tamsulosin after the clinical and radiographic diagnosis of acute urolithiasis will produce an increase in the proportion of patients passing their stone within 28 days.

Conditions Studied

Interventions

• OTHER Placebo
• DRUG tamsulosin

Study Locations (4)