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

Not Applicable

Completed

• Conditions: Nephrolithiasis; Ureteral Calculi
• Interventions: Drug: tamsulosin; Drug: Standard therapy with ibuprofen and oxycodone.

• Registration Number: NCT00600405
• Lead Sponsor: MaineHealth

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.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2008-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-14
• Last Update Submitted: 2008-01-14
• Study First Posted: 2008-01-25
• Last Update Posted: 2008-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	tamsulosin	Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
II	Standard therapy with ibuprofen and oxycodone.	Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.

Primary Outcome Measures

Name	Time	Method
Rate of spontaneous ureteral stone expulsion	48, 120, 336 hours

Secondary Outcome Measures

Name	Time	Method
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
Adverse medication-related events.	48, 120, 336 hours
Number of return ED visits or unscheduled PCP visits for continued pain.	48, 120, 336 hours
Amount of narcotic pain medication used.	48, 120, 336 hours

Trial Locations

Locations (1)

Maine Medical Center; 🇺🇸 Portland, Maine, United States