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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2007

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.

Intervention(s) in this Clinical Trial

• Drug: tamsulosin
  • Tamsulosin 0.4 mg orally daily for ten days.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: I
  • Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
• Other: II
  • Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.

Primary Measures

• Rate of spontaneous ureteral stone expulsion
  • Time Frame: 48, 120, 336 hours
    Safety Issue?: No

Secondary Measures

• Time to spontaneous ureteral stone expulsion.
  • Time Frame: 48, 120, 336 hours
    Safety Issue?: No
• Self-reported NRS-11 pain scores.
  • Time Frame: 48, 120, 336 hours
    Safety Issue?: No
• Number of colicky pain episodes.
  • Time Frame: 48, 120, 336 hours
    Safety Issue?: No
• Number of days missed work or usual functional ability.
  • Time Frame: 48, 120, 336 hours
    Safety Issue?: No
• Number of return ED visits or unscheduled PCP visits for continued pain.
  • Time Frame: 48, 120, 336 hours
    Safety Issue?: No
• Amount of narcotic pain medication used.
  • Time Frame: 48, 120, 336 hours
    Safety Issue?: Yes
• Adverse medication-related events.
  • Time Frame: 48, 120, 336 hours
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Maine Medical Center

Overall Clinical Trial Officials and Contacts

Andrew D Perron, MD Principal Investigator Maine Medical Center  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00600405

Study ID Number: 2958

ClinicalTrials.gov Identifier: NCT00600405

Health Authority: United States: Institutional Review Board