The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MaineHealth
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Rate of spontaneous ureteral stone expulsion
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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;
- •presence of multiple ureteral stones;
- •peptic ulcer disease;
- •liver failure;
- •concomitant treatment with alpha-lytic drugs, calcium antagonists, nitrates, or vardenafil (Levitra);
- •pregnancy;
Arms & Interventions
I
Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
Intervention: tamsulosin (Drug)
II
Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.
Intervention: Standard therapy with ibuprofen and oxycodone. (Drug)
Outcomes
Primary Outcomes
Rate of spontaneous ureteral stone expulsion
Time Frame: 48, 120, 336 hours
Secondary Outcomes
- 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)