Tamsulosin for Urolithiasis in the Emergency Dept (STONE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00382265
First received: September 28, 2006
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.

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.


Condition Intervention Phase
Nephrolithiasis
Drug: tamsulosin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Tamsulosin for Urolithiasis in the Emergency Department

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Proportion of patients passing their stone within 28 days. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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.

    Determination of the symptomatic stone In cases in which there is more than one stone noted on the CT scan, the physician treating the patient will determine the likely location and dimensions of the stone causing symptoms by reviewing the patient's ED record.

    Multiple stones If the physician believes that the symptomatic stone has not yet reached the bladder the patient may be offered enrollment. If there are multiple stones and the physician believes that the stone causing symptoms has reached the bladder, the patient will not be eligible for enrollment.

    Definition of stone expulsion Stone expulsion will be defined as a report by the patient that the stone was noted to have passed by visualization or capture after urination and that the pain has been relieved.



Secondary Outcome Measures:
  • Length of time in pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • • Need for surgical intervention / lithotripsy • Cost savings • Time until stone expulsion • Total amount of analgesia • Days of work lost [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Together with these secondary hypotheses, a secondary objective is to identify the most appropriate clinical subgroup(s) for treatment.


Estimated Enrollment: 500
Study Start Date: January 2008
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Tamsulosin 0.4mg PO
Drug: tamsulosin
tamsulosin 0.4mg po qd for 28 days
Placebo Comparator: 2
Placebo
Drug: tamsulosin
tamsulosin 0.4mg po qd for 28 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 outside of the ureters (i.e. within kidney or 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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382265

Contacts
Contact: Andrew C Meltzer, MD 2027412952 ameltzer@mfa.gwu.edu
Contact: Pamela K Burrows, MS 301-881-9260 pam_b@bsc.gwu.edu

Locations
United States, District of Columbia
The George Washington University Medical Center Recruiting
Washington, District of Columbia, United States, 20037
Contact: Andrew C Meltzer, MD    202-445-7044    ameltzer@mfa.gwu.edu   
Contact: Reggie Williams    2020-741-2420    rewilliams@mfa.gwu.edu   
Principal Investigator: Andrew C Meltzer, MD         
Sub-Investigator: Thomas Jarrett, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Judd Hollander, MD       Judd.Hollander@uphs.upenn.edu   
Contact: Niel Chen    215-662-3908    Niel' 'Chen <Niel.Chen@uphs.upenn.edu>   
Principal Investigator: Judd Hollander, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Allan B Wolfson, MD       wolfsonab@upmc.edu   
Contact: Sara Vandruff       vandruffsm@upmc.edu   
Principal Investigator: Allan B Wolfson, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Andrew C Meltzer, MD The George Washington University
  More Information

No publications provided

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00382265     History of Changes
Other Study ID Numbers: DK71603 (completed)
Study First Received: September 28, 2006
Last Updated: July 22, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
urolithiasis
renal colic
kidney stones

Additional relevant MeSH terms:
Nephrolithiasis
Emergencies
Urolithiasis
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 09, 2014