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

This study has been completed.
Sponsor:
Collaborator:
Maine Medical Center Mentored Research Committee
Information provided by:
Maine Medical Center
ClinicalTrials.gov Identifier:
NCT00600405
First received: January 14, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Kidney Stones
U.S. FDA Resources

Further study details as provided by Maine Medical Center:

Primary Outcome Measures:
  • Rate of spontaneous ureteral stone expulsion [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Andrew Perron, MD, Maine Medical Center
ClinicalTrials.gov Identifier: NCT00600405     History of Changes
Other Study ID Numbers: 2958
Study First Received: January 14, 2008
Last Updated: January 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Maine Medical Center:
Nephrolithiasis
Ureteral Calculi

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

ClinicalTrials.gov processed this record on June 18, 2013