Tamsulosin for Urolithiasis in the Emergency Dept (STONE)
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:
- tamsulosin for a maximum of 28 days;
- 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:
- to determine if tamsulosin is effective, and
- 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:
- a reduction in time to pain free recovery and hence a more rapid return to employment;
- decreased requirements for narcotic analgesia;
- less need for urological out-patient clinic follow-up;
- decreased need for surgical intervention or lithotripsy; and
- 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 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Study of Tamsulosin for Urolithiasis in the Emergency Department|
- Proportion of patients passing their stone within 28 days by self report [ Time Frame: 28 days ] [ Designated as safety issue: No ]
The administration of tamsulosin after the clinical and radiographic diagnosis of acute urolithiasis produces an increase in the proportion of patients passing their stone within 28 days.
Determination of the symptomatic stone In cases in which there is more than one stone noted on the CT scan, the physician treating the patient will determine the likely location and dimensions of the stone causing symptoms by reviewing the patient's ED record.
Multiple stones If the physician believes that the symptomatic stone has not yet reached the bladder the patient may be offered enrollment. If there are multiple stones and the physician believes that the stone causing symptoms has reached the bladder, the patient will not be eligible for enrollment.
Definition of stone expulsion Stone expulsion will be defined as a report by the patient that the stone was noted to have passed by visualization or capture after urination and that the pain has been relieved.
- Length of time in pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Need for surgical intervention [ Time Frame: 90 days ] [ Designated as safety issue: No ]Together with these secondary hypotheses, a secondary objective is to identify the most appropriate clinical subgroup(s) for treatment.
- Crossover to open label Tamsulosin [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Confirmation of Stone Passage on CT [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Days of work lost [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Amount of Analgesia [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Tamsulosin 0.4mg PO
tamsulosin 0.4mg po qd for 28 days
Placebo Comparator: 2
tamsulosin 0.4mg po qd for 28 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382265
|United States, Alabama|
|University of Alabama - Birmingham|
|Birmingham, Alabama, United States, 35249|
|United States, District of Columbia|
|The George Washington University Medical Center|
|Washington, District of Columbia, United States, 20037|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Andrew C Meltzer, MD||The George Washington University|