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Tamsulosin for Urolithiasis in the Emergency Dept (STONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00382265
Recruitment Status : Completed
First Posted : September 29, 2006
Results First Posted : December 10, 2018
Last Update Posted : December 10, 2018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Andrew Meltzer, George Washington University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Ureterolithiases Drug: tamsulosin Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of Tamsulosin for Urolithiasis in the Emergency Department
Study Start Date : January 2008
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Tamsulosin
Tamsulosin 0.4mg PO qd for 28 days
Drug: tamsulosin
tamsulosin 0.4mg po qd for 28 days

Placebo Comparator: Placebo
Placebo PO qd for 28 days
Other: Placebo
placebo po qd for 28 days

Primary Outcome Measures :
  1. Proportion of Patients Passing Their Stone Within 28 Days by Self Report [ Time Frame: 28 days ]
    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.

Secondary Outcome Measures :
  1. Any Pain Medication [ Time Frame: 28 days ]
    Patients on any pain medication at day 28

  2. Need for Surgical Intervention [ Time Frame: 28 days ]
  3. Crossover to Open Label Tamsulosin [ Time Frame: 28 days ]
  4. Confirmation of Stone Passage on CT [ Time Frame: 28 days ]
  5. Return to Work (if Employed) [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Evidence of ureterolithiasis (i.e. stone is located in ureter, not in bladder) as demonstrated on radiographic studies, specifically non-contrast spiral CT.
  3. Willingness to participate and able to proceed with standard outpatient management (no personal or job-related issues, e.g. airline pilot.
  4. Has a telephone in order to be contacted for follow-up.

Exclusion Criteria:

  1. Patient desiring or requiring immediate surgical intervention making then not a candidate for outpatient kidney stone management.
  2. Current urinary tract infection based on urine dipstick as admission and urgent procedural management are likely indicated.
  3. Known anatomical genitourinary abnormalities or prior Genitourinary surgeries.
  4. Positive pregnancy test making proper radiological imaging contraindicated.
  5. Breastfeeding mothers.
  6. History of hypersensitivity to tamsulosin.
  7. Current use of alpha blockers or calcium channel blockers.
  8. Current use of steroids which may have an independent effect on stone expulsion.
  9. Spontaneous stone expulsion prior to enrollment.
  10. Largest stone dimension ≥ 9mm assessed using radiologic imaging, being very unlikely to pass spontaneously.
  11. Presence of stone in the bladder.
  12. Current use of vardenafil which is tamsulosin contraindicated.
  13. Ipsilateral, transplanted or solitary kidney as hospitalization may be necessary.
  14. Known renal insufficiency.
  15. Fever defined as >101.5°F which may indicate infection.
  16. Floppy iris syndrome which is tamsulosin contraindicated.
  17. Planned cataract surgery in the next 60 days which is tamsulosin contraindicated.
  18. Prisoners /wards of state.
  19. Prior enrollment in STONE (Candidates who are screened and found ineligible may be rescreened at a later date.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00382265

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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
Sponsors and Collaborators
Andrew Meltzer
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Andrew C Meltzer, MD The George Washington University
  Study Documents (Full-Text)

Documents provided by Andrew Meltzer, George Washington University:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Andrew Meltzer, Principal Investigator, George Washington University Identifier: NCT00382265    
Other Study ID Numbers: RO1 DK71603
U01DK096037 ( U.S. NIH Grant/Contract )
U01DK071603 ( U.S. NIH Grant/Contract )
U34DK090957 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2006    Key Record Dates
Results First Posted: December 10, 2018
Last Update Posted: December 10, 2018
Last Verified: November 2018
Keywords provided by Andrew Meltzer, George Washington University:
renal colic
kidney stones
urinary stone disease
Additional relevant MeSH terms:
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Urinary Calculi
Ureteral Calculi
Disease Attributes
Pathologic Processes
Urologic Diseases
Pathological Conditions, Anatomical
Ureteral Diseases
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents