Ureterolithiases Clinical Trial
Official title:
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03656913 -
Validation of Low Dose CT for Diagnosis of Urolithiasis
|
N/A |