The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

MaineHealth81 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nephrolithiasis Ureteral Calculi

Interventions

tamsulosinDRUG

Tamsulosin 0.4 mg orally daily for ten days.

Standard therapy with ibuprofen and oxycodone.DRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Maine Medical Center

Portland, Maine, United States