The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
1 other identifier
interventional
81
1 country
1
Brief Summary
The purpose of this study is to determine the efficacy of the α-adrenergic antagonist tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic secondary to lower ureteral calculus. We hypothesize that there will be no difference in outcomes for subjects treated with and without tamsulosin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 14, 2008
CompletedFirst Posted
Study publicly available on registry
January 25, 2008
CompletedJanuary 25, 2008
January 1, 2008
1.3 years
January 14, 2008
January 14, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of spontaneous ureteral stone expulsion
48, 120, 336 hours
Secondary Outcomes (7)
Time to spontaneous ureteral stone expulsion.
48, 120, 336 hours
Self-reported NRS-11 pain scores.
48, 120, 336 hours
Number of colicky pain episodes.
48, 120, 336 hours
Number of days missed work or usual functional ability.
48, 120, 336 hours
Number of return ED visits or unscheduled PCP visits for continued pain.
48, 120, 336 hours
- +2 more secondary outcomes
Study Arms (2)
I
EXPERIMENTALSubjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
II
OTHERStandard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.
Interventions
Oxycodone: 5mg, one to two tablets every four to six hours as needed for pain. Ibuprofen: 800 mg, one three times a day with food as needed for pain.
Eligibility Criteria
You may qualify if:
- years of age or older;
- able to read, write, and speak English;
- able to use the NRS pain scale; and
- computed tomography diagnosed single lower ureteral calculus
You may not qualify if:
- allergy or sensitivity to the study drug (tamsulosin hydrochloride \[Flomax\]);
- sulfa/sulfonamide allergy;
- inability to provide informed consent;
- lithiasis of the ureteral intramural tract;
- acute or chronic renal failure;
- fever;
- presence of multiple ureteral stones;
- peptic ulcer disease;
- liver failure;
- concomitant treatment with alpha-lytic drugs, calcium antagonists, nitrates, or vardenafil (Levitra);
- pregnancy;
- breastfeeding; or
- a history of urinary surgery or endoscopic treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MaineHealthlead
- Maine Medical Center Mentored Research Committeecollaborator
Study Sites (1)
Maine Medical Center
Portland, Maine, 04102, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew D Perron, MD
MaineHealth
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 14, 2008
First Posted
January 25, 2008
Study Start
August 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
January 25, 2008
Record last verified: 2008-01