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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nephrolithiasis, Ureteral Calculi

Intervention / Treatment
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* Drug: tamsulosin
* Drug: Standard therapy with ibuprofen and oxycodone.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days. | Drug: tamsulosin<br>* Tamsulosin 0.4 mg orally daily for ten days.<br>* Other names: Flomax;|
| Other: II<br>Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone. | Drug: Standard therapy with ibuprofen and oxycodone.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of spontaneous ureteral stone expulsion |  | 48, 120, 336 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nephrolithiasis, Ureteral Calculi