Status:
COMPLETED
Tamsulosin for Urolithiasis in the Emergency Dept
Lead Sponsor:
Andrew Meltzer
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Ureterolithiases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Evidence of ureterolithiasis (i.e. stone is located in ureter, not in bladder) as demonstrated on radiographic studies, specifically non-contrast spiral CT.
- Willingness to participate and able to proceed with standard outpatient management (no personal or job-related issues, e.g. airline pilot.
- Has a telephone in order to be contacted for follow-up.
Exclusion
- Patient desiring or requiring immediate surgical intervention making then not a candidate for outpatient kidney stone management.
- Current urinary tract infection based on urine dipstick as admission and urgent procedural management are likely indicated.
- Known anatomical genitourinary abnormalities or prior Genitourinary surgeries.
- Positive pregnancy test making proper radiological imaging contraindicated.
- Breastfeeding mothers.
- History of hypersensitivity to tamsulosin.
- Current use of alpha blockers or calcium channel blockers.
- Current use of steroids which may have an independent effect on stone expulsion.
- Spontaneous stone expulsion prior to enrollment.
- Largest stone dimension ≥ 9mm assessed using radiologic imaging, being very unlikely to pass spontaneously.
- Presence of stone in the bladder.
- Current use of vardenafil which is tamsulosin contraindicated.
- Ipsilateral, transplanted or solitary kidney as hospitalization may be necessary.
- Known renal insufficiency.
- Fever defined as \>101.5°F which may indicate infection.
- Floppy iris syndrome which is tamsulosin contraindicated.
- Planned cataract surgery in the next 60 days which is tamsulosin contraindicated.
- Prisoners /wards of state.
- Prior enrollment in STONE (Candidates who are screened and found ineligible may be rescreened at a later date.)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
512 Patients enrolled
Trial Details
Trial ID
NCT00382265
Start Date
January 1 2008
End Date
February 1 2017
Last Update
December 10 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35249
2
The George Washington University Medical Center
Washington D.C., District of Columbia, United States, 20037
3
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261