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

MaineHealth

Status: Completed

Conditions: Ureteral Calculi; Nephrolithiasis

Treatments: Drug: Standard therapy with ibuprofen and oxycodone.; Drug: tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT00600405

2958

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

I

Experimental group

Description:

Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.

Treatment:

Drug: tamsulosin

II

Other group

Description:

Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.

Treatment:

Drug: Standard therapy with ibuprofen and oxycodone.