Nephrolithiasis Clinical Trial
Official title:
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Verified date | January 2008 |
Source | Maine Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Maine Medical Center | Portland | Maine |
Lead Sponsor | Collaborator |
---|---|
Maine Medical Center | Maine Medical Center Mentored Research Committee |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of spontaneous ureteral stone expulsion | 48, 120, 336 hours | No | |
Secondary | Time to spontaneous ureteral stone expulsion. | 48, 120, 336 hours | No | |
Secondary | Self-reported NRS-11 pain scores. | 48, 120, 336 hours | No | |
Secondary | Number of colicky pain episodes. | 48, 120, 336 hours | No | |
Secondary | Number of days missed work or usual functional ability. | 48, 120, 336 hours | No | |
Secondary | Number of return ED visits or unscheduled PCP visits for continued pain. | 48, 120, 336 hours | No | |
Secondary | Amount of narcotic pain medication used. | 48, 120, 336 hours | Yes | |
Secondary | Adverse medication-related events. | 48, 120, 336 hours | Yes |
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