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

January 14, 2008 updated by: MaineHealth
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I
Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
Drug: tamsulosin
Tamsulosin 0.4 mg orally daily for ten days.
Other Names:
  • Flomax
Other: II
Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MaineHealth

Collaborators

Maine Medical Center Mentored Research Committee

Investigators

  • Principal Investigator: Andrew D Perron, MD, MaineHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

January 25, 2008

Last Update Submitted That Met QC Criteria

January 14, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2958

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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