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

Sponsor

MaineHealth (Other)

Overall Status

Completed

CT.gov ID

NCT00600405

Collaborator

Maine Medical Center Mentored Research Committee (Other)

Enrollment

Location

Arms

Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrolithiasis Ureteral Calculi	Drug: tamsulosin Drug: Standard therapy with ibuprofen and oxycodone.	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.	Drug: tamsulosin Tamsulosin 0.4 mg orally daily for ten days. Other Names: Flomax
Other: II Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.	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.

Arm

Intervention/Treatment

Experimental: I

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

Drug: tamsulosin

Tamsulosin 0.4 mg orally daily for ten days.

Other Names:

Flomax

Other: II

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

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.

Outcome Measures

Primary Outcome Measures

Rate of spontaneous ureteral stone expulsion [48, 120, 336 hours]

Secondary Outcome Measures

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]
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]
Adverse medication-related events. [48, 120, 336 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.