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 302 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.

The secondary 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 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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2010

Intervention(s) in this Clinical Trial

• Drug: tamsulosin
  • tamsulosin 0.4mg po qd for 28 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Tamsulosin 0.4mg PO
• Placebo Comparator: 2
  • Placebo

Primary Measures

• The proportion of patients passing their stone at 28 days
  • Time Frame: 28 days
    Safety Issue?: No

Secondary Measures

• Time to passage of stone Length of time in pain Number of days lost from work Need for surgical intervention or lithotripsy Overall costs
  • Time Frame: 28 days
    Safety Issue?: No

Inclusion Criteria:

• Age > 18
• Evidence of urolithiasis
• Acceptable for outpatient stone management

Exclusion Criteria:

• Urinary tract infection
• Known anatomical genitourinary (GU) abnormalities, or prior GU surgeries
• Diabetes
• Ulcer disease
• Osteoporosis
• Pregnancy
• Psychiatric disorder
• History of hypersensitivity to tamsulosin or corticosteroids
• Spontaneous stone expulsion in the ED
• Largest stone dimension .9mm
• Concurrent use of vardenafil (Levitra)
• Solitary kidney
• Transplanted kidney
• Renal insufficiency
• Fever
• Prisoners or wards of state

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Overall Clinical Trial Officials and Contacts

Jeremy Brown, MD Principal Investigator The George Washington University  

Overall Contact: Jeremy Brown, MD 2027412911 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00382265

Study ID Number: DK71603

ClinicalTrials.gov Identifier: NCT00382265

Health Authority: United States: Federal Government