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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2007

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

  • 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

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Rate of spontaneous ureteral stone expulsion
    • Time Frame: 48, 120, 336 hours

Secondary Measures

  • Time to spontaneous ureteral stone expulsion.
    • Time Frame: 48, 120, 336 hours
  • Self-reported NRS-11 pain scores.
    • Time Frame: 48, 120, 336 hours
  • Number of colicky pain episodes.
    • Time Frame: 48, 120, 336 hours
  • Number of days missed work or usual functional ability.
    • Time Frame: 48, 120, 336 hours
  • Number of return ED visits or unscheduled PCP visits for continued pain.
    • Time Frame: 48, 120, 336 hours
  • Amount of narcotic pain medication used.
    • Time Frame: 48, 120, 336 hours
  • Adverse medication-related events.
    • Time Frame: 48, 120, 336 hours

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MaineHealth
  • Collaborator
    • Maine Medical Center Mentored Research Committee
  • Provider of Information About this Clinical Study
    • Andrew Perron, MD, Maine Medical Center
  • Overall Official(s)
    • Andrew D Perron, MD, Principal Investigator, MaineHealth

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