The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Information source: Maine Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nephrolithiasis; Ureteral Calculi
Intervention: tamsulosin (Drug); Standard therapy with ibuprofen and oxycodone. (Drug)
Phase: N/A
Status: Completed
Sponsored by: Maine Medical Center Official(s) and/or principal investigator(s):
Andrew D Perron, MD, Principal Investigator, Affiliation: Maine Medical Center
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.
Clinical Details
Official title: The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rate of spontaneous ureteral stone expulsion
Secondary outcome: Time to spontaneous ureteral stone expulsion.Self-reported NRS-11 pain scores. Number of colicky pain episodes. Number of days missed work or usual functional ability. Number of return ED visits or unscheduled PCP visits for continued pain. Amount of narcotic pain medication used. Adverse medication-related events.
Detailed description:
This prospective, randomized controlled trial seeks to compare outcomes for adult emergency
department patients with lower ureteral calculus. Subjects will be randomized to receive
treatment with ibuprofen and oxycodone alone (standard therapy) or standard therapy plus
tamsulosin 0. 4mg orally once daily for ten days.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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.
Locations and Contacts
Maine Medical Center, Portland, Maine 04102, United States
Additional Information
Starting date: August 2006
Ending date: November 2007
Last updated: January 14, 2008
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