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

NCT ID: NCT00600405

Last Updated: 2008-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-11-30

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.

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.

Conditions

Nephrolithiasis; Ureteral Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I

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

Group Type: EXPERIMENTAL

tamsulosin

Intervention Type: DRUG

Tamsulosin 0.4 mg orally daily for ten days.

II

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

Group Type: OTHER

Standard therapy with ibuprofen and oxycodone.

Intervention Type: 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.

Interventions

tamsulosin

Tamsulosin 0.4 mg orally daily for ten days.

Intervention Type: DRUG

Standard therapy with ibuprofen and oxycodone.

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.

Intervention Type: DRUG

Other Intervention Names

Flomax

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maine Medical Center Mentored Research Committee

UNKNOWN

Sponsor Role: collaborator

MaineHealth

OTHER

Sponsor Role: lead

Responsible Party

Maine Medical Center

Principal Investigators

Andrew D Perron, MD

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Locations

Maine Medical Center

Portland, Maine, United States

Countries

United States

Other Identifiers

2958

Identifier Type: -

Identifier Source: org_study_id