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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600405
First Posted: January 25, 2008
Last Update Posted: January 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Maine Medical Center Mentored Research Committee
Information provided by:
Maine Medical Center
  Purpose
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.

Condition Intervention
Nephrolithiasis Ureteral Calculi Drug: tamsulosin Drug: Standard therapy with ibuprofen and oxycodone.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

Resource links provided by NLM:


Further study details as provided by Maine Medical Center:

Primary Outcome Measures:
  • Rate of spontaneous ureteral stone expulsion [ Time Frame: 48, 120, 336 hours ]

Secondary Outcome 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 ]

Enrollment: 81
Study Start Date: August 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Flomax
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600405


Locations
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Maine Medical Center
Maine Medical Center Mentored Research Committee
Investigators
Principal Investigator: Andrew D Perron, MD Maine Medical Center
  More Information

Responsible Party: Andrew Perron, MD, Maine Medical Center
ClinicalTrials.gov Identifier: NCT00600405     History of Changes
Other Study ID Numbers: 2958
First Submitted: January 14, 2008
First Posted: January 25, 2008
Last Update Posted: January 25, 2008
Last Verified: January 2008

Keywords provided by Maine Medical Center:
Nephrolithiasis
Ureteral Calculi

Additional relevant MeSH terms:
Emergencies
Calculi
Nephrolithiasis
Kidney Calculi
Ureteral Calculi
Ureterolithiasis
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Ureteral Diseases
Ibuprofen
Oxycodone
Tamsulosin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics