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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

Tracking Information
First Submitted Date  ICMJE September 28, 2006
First Posted Date  ICMJE September 29, 2006
Results First Submitted Date  ICMJE May 1, 2018
Results First Posted Date  ICMJE December 10, 2018
Last Update Posted Date December 10, 2018
Study Start Date  ICMJE January 2008
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Any Pain Medication [ Time Frame: 28 days ]
    Patients on any pain medication at day 28
  • Need for Surgical Intervention [ Time Frame: 28 days ]
  • Crossover to Open Label Tamsulosin [ Time Frame: 28 days ]
  • Confirmation of Stone Passage on CT [ Time Frame: 28 days ]
  • Return to Work (if Employed) [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Tamsulosin for Urolithiasis in the Emergency Dept
Official Title  ICMJE Study of Tamsulosin for Urolithiasis in the Emergency Department
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ureterolithiases
Intervention  ICMJE
  • Drug: tamsulosin
    tamsulosin 0.4mg po qd for 28 days
  • Other: Placebo
    placebo po qd for 28 days
Study Arms  ICMJE
  • Active Comparator: Tamsulosin
    Tamsulosin 0.4mg PO qd for 28 days
    Intervention: Drug: tamsulosin
  • Placebo Comparator: Placebo
    Placebo PO qd for 28 days
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2018)
Original Enrollment  ICMJE
 (submitted: September 28, 2006)
Actual Study Completion Date  ICMJE February 1, 2017
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00382265
Other Study ID Numbers  ICMJE RO1 DK71603
U01DK096037 ( U.S. NIH Grant/Contract )
U01DK071603 ( U.S. NIH Grant/Contract )
U34DK090957 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Andrew Meltzer, George Washington University
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Andrew Meltzer
Original Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Andrew C Meltzer, MD The George Washington University
PRS Account George Washington University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP