Nephrolithiasis, Ureteral Calculi
Conditions
Keywords
Nephrolithiasis, Ureteral Calculi
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.
Interventions
DRUGtamsulosin
Tamsulosin 0.4 mg orally daily for ten days.
DRUGStandard 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.
Sponsors
Maine Medical Center Mentored Research Committee
MaineHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of spontaneous ureteral stone expulsion | 48, 120, 336 hours |
Secondary
| Measure | 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 |
| Amount of narcotic pain medication used. | 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 |
Countries
United States
Outcome results
None listed