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Tamsulosin for Urolithiasis in the Emergency Dept (STONE)

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ClinicalTrials.gov Identifier: NCT00382265
Recruitment Status : Completed
First Posted : September 29, 2006
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

September 28, 2006
September 29, 2006
April 4, 2017
January 2008
October 1, 2016   (Final data collection date for primary outcome measure)
Proportion of patients passing their stone within 28 days by self report [ Time Frame: 28 days ]
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.
Not Provided
Complete list of historical versions of study NCT00382265 on ClinicalTrials.gov Archive Site
  • Length of time in pain [ Time Frame: 30 days ]
  • Need for surgical intervention [ Time Frame: 90 Days ]
  • Crossover to open label Tamsulosin [ Time Frame: 30 days ]
  • Confirmation of Stone Passage on CT [ Time Frame: 30 days ]
  • Days of work lost [ Time Frame: 30 days ]
  • Amount of Analgesia [ Time Frame: 30 days ]
Not Provided
Not Provided
Not Provided
 
Tamsulosin for Urolithiasis in the Emergency Dept
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 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Ureterolithiases
Drug: tamsulosin
tamsulosin 0.4mg po qd for 28 days
  • Active Comparator: 1
    Tamsulosin 0.4mg PO
    Intervention: Drug: tamsulosin
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: tamsulosin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
302
Not Provided
October 1, 2016   (Final data collection date for primary outcome measure)

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 GU 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.)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00382265
RO1 DK71603
U34DK090957 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Andrew C Meltzer, MD The George Washington University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2017

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